Search results for: randomized clinical trial
Commenced in January 2007
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Edition: International
Paper Count: 4802

Search results for: randomized clinical trial

4652 An Analysis of the Results of Trial Blasting of Site Development Project in the Volcanic Island

Authors: Dong Wook Lee, Seung Hyun Kim

Abstract:

Trial blasting is conducted to identify the characteristics of the blasting of the applicable ground before production blasting and to investigate various problems posed by blasting. The methods and pattern of production blasting are determined based on an analysis of the results of trial blasting. The bedrock in Jeju Island, South Korea is formed through the volcanic activities unlike the inland areas, composed of porous basalt. Trial blasting showed that the blast vibration frequency of sedimentary and metamorphic rocks in the inland areas is in a high frequency band of about 80 Hz while the blast vibration frequency of Jeju Island is in a low frequency band of 10~25 Hz. The frequency band is analyzed to be low due to the large cycle of blasting pattern as blast vibration passes through the layered structured ground layer where the rock formation and clickers irregularly repeat. In addition, the blast vibration equation derived from trial blasting was R: 0.885, S.E: 0.216 when applying the square root scaled distance (SRSD) relatively suitable for long distance, estimated at the confidence level of 95%.

Keywords: attenuation index, basaltic ground, blast vibration constant, blast vibration equation, clinker layer

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4651 Evidence-Based in Telemonitoring of Users with Pacemakers at Five Years after Implant: The Poniente Study

Authors: Antonio Lopez-Villegas, Daniel Catalan-Matamoros, Remedios Lopez-Liria

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Objectives: The purpose of this study was to analyze clinical data, health-related quality of life (HRQoL) and functional capacity of patients using a telemonitoring follow-up system (TM) compared to patients followed-up through standard outpatient visits (HM) 5 years after the implantation of a pacemaker. Methods: This is a controlled, non-randomised, nonblinded clinical trial, with data collection carried out at 5 years after the pacemakers implant. The study was developed at Hospital de Poniente (Almeria, Spain), between October 2012 and November 2013. The same clinical outcomes were analyzed in both follow-up groups. Health-Related Quality of Life and Functional Capacity was assessed through EuroQol-5D (EQ-5D) questionnaire and Duke Activity Status Index (DASI) respectively. Sociodemographic characteristics and clinical data were also analyzed. Results: 5 years after pacemaker implant, 55 of 82 initial patients finished the study. Users with pacemakers were assigned to either a conventional follow-up group at hospital (HM=34, 50 initials) or a telemonitoring system group (TM=21, 32 initials). No significant differences were found between both groups according to sociodemographic characteristics, clinical data, Health-Related Quality of Life and Functional Capacity according to medical record and EQ5D and DASI questionnaires. In addition, conventional follow-up visits to hospital were reduced in 44,84% (p < 0,001) in the telemonitoring group in relation to hospital monitoring group. Conclusion: Results obtained in this study suggest that the telemonitoring of users with pacemakers is an equivalent option to conventional follow-up at hospital, in terms of Health-Related Quality of Life and Functional Capacity. Furthermore, it allows for the early detection of cardiovascular and pacemakers-related problem events and significantly reduces the number of in-hospital visits. Trial registration: ClinicalTrials.gov NCT02234245. The PONIENTE study has been funded by the General Secretariat for Research, Development and Innovation, Regional Government of Andalusia (Spain), project reference number PI/0256/2017, under the research call 'Development and Innovation Projects in the Field of Biomedicine and Health Sciences', 2017.

Keywords: cardiovascular diseases, health-related quality of life, pacemakers follow-up, remote monitoring, telemedicine

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4650 A Two Arm Double Parallel Randomized Controlled Trail of the Effects of Health Education Intervention on Insecticide Treated Nets Use and Its Practices among Pregnant Women Attending Antenatal Clinic: Study Protocol

Authors: Opara Monica, Suriani Ismail, Ahmad Iqmer Nashriq Mohd Nazan

Abstract:

The true magnitude of the mortality and morbidity attributable to malaria worldwide is, at best, a scientific guess, although it is not disputable that the greatest burden is in sub-Saharan Africa. Those at highest risk are children younger than 5 years and pregnant women, particularly primigravidae. Nationally, malaria remains the third leading cause of death and is still considered a major public health problem. Therefore, this study is aimed to assess the effectiveness of health education intervention on insecticide-treated net use and its practices among pregnant women attending antenatal clinics. Materials and Methods: This study will be an intervention study with two arms double parallel randomized controlled trial (blinded) to be conducted in 3 stages. The first stage will develop health belief model (HBM) program, while in the second stage, pregnant women will be recruited, assessed (baseline data), randomized into two arms of the study, and follow-up for six months. The third stage will evaluate the impact of the intervention on HBM and disseminate the findings. Data will be collected with the use of a structured questionnaire which will contain validated tools. The main outcome measurement will be the treatment effect using HBM, while data will be analysed using SPSS, version 22. Discussion: The study will contribute to the existing knowledge on hospital-based care programs for pregnant women in developing countries where the literature is scanty. It will generally give insight into the importance of HBM measurement in interventional studies on malaria and other related infectious diseases in this setting.

Keywords: malaria, health education, insecticide-treated nets, sub-Saharan Africa

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4649 Abdominal Exercises Can Modify Abdominal Function in Postpartum Women: A Randomized Control Trial Comparing Curl-up to Drawing-in Combined With Diaphragmatic Aspiration

Authors: Yollande Sènan Djivoh, Dominique de Jaeger

Abstract:

Background: Abdominal exercises are commonly practised nowadays. Specific techniques of abdominal muscles strengthening like hypopressive exercises have recently emerged and their practice is encouraged against the practice of Curl-up especially in postpartum. The acute and the training effects of these exercises did not allow to advise one exercise to the detriment of another. However, physiotherapists remain reluctant to perform Curl-up with postpartum women because of its potential harmful effect on the pelvic floor. Design: This study was a randomized control trial registered under the number PACTR202110679363984. Objective: to observe the training effect of two experimental protocols (Curl-up versus Drawing-in+Diaphragmatic aspiration) on the abdominal wall (interrecti distance, rectus and transversus abdominis thickness, abdominal strength) in Beninese postpartum women. Pelvic floor function (tone, endurance, urinary incontinence) will be assessed to evaluate potential side effects of exercises on the pelvic floor. Method: Postpartum women diagnosed with diastasis recti were randomly assigned to one of three groups (Curl-up, Drawingin+Diaphragmatic aspiration and control). Abdominal and pelvic floor parameters were assessed before and at the end of the 6-week protocol. The interrecti distance and the abdominal muscles thickness were assessed by ultrasound and abdominal strength by dynamometer. Pelvic floor tone and strength were assessed with Biofeedback and urinary incontinence was quantified by pad test. To compare the results between the three groups and the two measurements, a two-way Anova test with repeated measures was used (p<0.05). When interaction was significant, a posthoc using Student t test, with Bonferroni correction, was used to compare the three groups regarding the difference (end value minus initial value). To complete these results, a paired Student t test was used to compare in each group the initial and end values. Results: Fifty-eight women participated in this study, divided in three groups with similar characteristics regarding their age (29±5 years), parity (2±1 children), BMI (26±4 kg/m2 ), time since the last birth (10±2 weeks), weight of their baby at birth (330±50 grams). Time effect and interaction were significant (p<0.001) for all abdominal parameters. Experimental groups improved more than control group. Curl-up group improved more (p=0.001) than Drawing-in+Diaphragmatic aspiration group regarding the interrecti distance (9.3±4.2 mm versus 6.6±4.6 mm) and abdominal strength (20.4±16.4 Newton versus 11.4±12.8 Newton). Drawingin+Diaphragmatic aspiration group improved (0.8±0.7 mm) more than Curl-up group (0.5±0.7 mm) regarding the transversus abdominis thickness (p=0.001). Only Curl-up group improved (p<0.001) the rectus abdominis thickness (1.5±1.2 mm). For pelvic floor parameters, both experimental groups improved (p=0.01) except for tone which improved (p=0.03) only in Drawing-in+Diaphragmatic aspiration group from 19.9±4.1 cmH2O to 22.2±4.5 cmH2O. Conclusion: Curl-up was more efficient to improve abdominal function than Drawingin+Diaphragmatic aspiration. However, these exercises are complementary. None of them degraded the pelvic floor, but Drawing-in+Diaphragmatic aspiration improved further the pelvic floor function. Clinical implications: Curl-up, Drawing-in and Diaphragmatic aspiration can be used for the management of abdominal function in postpartum women. Exercises must be chosen considering the specific needs of each woman’s abdominal and pelvic floor function.

Keywords: curl-up, drawing-in, diaphragmatic aspiration, hypopressive exercise, postpartum women

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4648 Bifidobacterium lactis Fermented Milk Was Not Effective to Eradication of Helicobacter Pylori Infection: A Prospective, Randomized, Double-Blind, Controlled Study

Authors: R. C. Barbuti, M. N. Oliveira, N. P. Perina, C. Haro, P. Bosch, C. S. Bogsan, J. N. Eisig, T. Navarro-Rodriguez

Abstract:

Background: The management of Helicobacter pylori (H. pylori) eradication is still a matter of discussion, full effectiveness is rarely achieved and it has many adverse effects. Probiotics are believed to have a role in eradicating and possibly preventing H. pylori infection as an adjunctive treatment. The present clinical study was undertaken to see the efficacy of a specially designed fermented milk product containing Bifidobacterium lactis B420 on the eradication of H. pylori infection in a prospective, randomized, double-blind, controlled study in humans. Method: Four test products were specially designed fermented milks, counts of viable cells in all products were 1010 Log CFU. 100 mL-1 for Bifidobacterium lactis-Bifidobacterium species 420, and 1011 Log CFU. 100 mL-1 for Streptococcus thermophiles were administered to subjects infected with H. pylori with a previous diagnosis of functional dyspepsia according to the Rome III criteria in a prospective, randomized, double-blind, placebo-controlled study in humans. Results: After FM supplementation, not all subjects showed a reduction in H. pylori colonization. Conclusion: Bifidobacterium lactis B420, administered twice a day for 90 days did not show an increase in H. pylori eradication effectiveness in Brazilian patients with functional dyspepsia.

Keywords: antibacterial therapy, Bifidobacteria fermented milk, Helicobacter pylori, probiotics

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4647 12-Week Comparative Clinical Trial with Low Dose Phentermine/Topiramate with Liraglutide on Obesity in Korea

Authors: Kyu Rae Lee

Abstract:

The aim of the study is to investigate the clinical efficacy of combination therapeutic modalities using liraglutide (1.2mg/d) add on low-dose phentermine (7.5 mg/d)/topiramate (50mg/d) medication on the obese patient in the bariatric clinic. We assessed the retrospective cohort clinical analyses to the clinical efficacy of medication and combination in the patients who visited the bariatric clinic. We measured all participants’ body fat (bioelectric impedance analysis), weight, height, and the cross-sectional areas of adipose tissues (umbilicus level) after keep fasting for 8 hours at 0, 4, 12 weeks. The design of the study was opened, paired t-test and Wilcoxon test were performed using SPSS for windows (ver.18, IL, USA) for comparison of weight, body fat, and adipose tissues. The participants were one hundred twenty-eight subjects aged 44.67 (1.18) years, 28.95 (0.39) kg/m², and female (82.7%). Their body fat was 40.57 (2.23%), and waist to hip ratio was 0.96 (0.01). The mean cross-sectional area of visceral adipose tissue was 142.59 (7.06) mm², and that of subcutaneous adipose was 274.37 (9.18) mm². 73 of them (57.5%) took medication only, 54 of them took medication with liraglutide for 12 weeks. The subjects in the medication group lost 5.4165 kg, 6.8069%, and those of the combination group did 6.2481 kg, 3.564%. The mean cross-sectional areas of visceral, subcutaneous adipose tissue in the medication group significantly decreased (p=.043), even more in the combination group. (p=.028). Further controlled clinical trials should be considered in the future. We conclude that the low dose of phentermine/topiramate with liraglutide therapeutic modalities would be more effective than phentermine/topiramate medication only in obesity treatment for 12 weeks.

Keywords: low dose phentermine, topiramate, liraglutide, obesity, efficacy

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4646 Comparison of Analgesic Efficacy of Ropivacaine and Levobupivacaine in Labour Analgesia by Dural Puncture Epidural Technique – A Prospective Double-blinded Randomized Trial

Authors: J. Punj, R. K. Pandey, V. Darlong, K. Thangavel

Abstract:

Background: Dural puncture epidural (DPE) technique has been introduced recently for labour analgesia however, no study has compared ropivacaine and levobupivacaine for the same. Methods: The primary aim of the study was to compare time to onset of the Numerical Pain Rating Score (NPRS) ≤ 1 in labour analgesia with both drugs. After obtaining ethics and patient consent, ASA I and ASA II parturient with single foetus in vertex presentation and cervical dilatation <5.0 cm were included. DPE was performed with 16/ 26 G combined spinal epidural (CSE) technique, and parturients randomized into two groups. In Group R ( Ropivacaine) 20 ml 0.125% ropivacaine+ fentanyl 2µg/ml was injected to a maximum of 20 ml in 20 minutes and in Group L (Levobupivacaine), 20 ml 0.125% levobupivacaine + fentanyl 2µg/ml was injected. Outcomes were assessed at 0.5,2,4,6,8,10,12,14,16,18,20 and 30 minutes, then every 90 minutes until delivery. Appropriate statistical analysis was done, and p value of <0.05 was considered statistically significant. Results: The median time to onset of NPRS ≤1 in both groups was comparable (group R= 16 minutes vs group L= 18 minutes (p = 0.076). Volume of drug for NPR ≤1 in both groups was also comparable (Group R 15.95± 2.03 ml vs Group L 16.35 ± 1.34 ml (p=0.47). Conclusion: DPE with 16 G epidural needle and 26 gauge spinal needle with both 0.125% ropivacaine and 0.125% levobupivacaine results in similar efficacy of labour analgesia.

Keywords: dural puncture epidural, labour analgesia, obstetric analgesia, hypotension

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4645 Screening of Different Exotic Varieties of Potato through Adaptability Trial for Local Cultivation

Authors: Arslan Shehroz, Muhammad Amjad Ali, Amjad Abbas, Imran Ramzan, Muhammad Zunair Latif

Abstract:

Potato (Solanum tuberosum L.) is the 4th most important food crop of the world after wheat, rice and maize. It is the staple food in many European countries. Being rich in starch (one of the main three food ingredients) and having the highest productivity per unit area, has great potential to address the challenge of the food security. Processed potato is also used as chips and crisps etc as ‘fast food’. There are many biotic and abiotic factors which check the production of potato and become hurdle in achievement production potential of potato. 20 new varieties along with two checks were evaluated. Plant to plant and row to row distances were maintained as 20 cm and 75 cm, respectively. The trial was conducted according to the randomized complete block design with three replications. Normal agronomic and plant protection measures were carried out in the crop. It is revealed from the experiment that exotic variety 171 gave the highest yield of 35.5 t/ha followed by Masai with 31.0 t/ha tuber yield. The check variety Simply Red 24.2 t/ha yield, while the lowest tuber yield (1.5 t/ha) was produced by the exotic variety KWS-06-125. The maximum emergence was shown by the Variety Red Sun (89.7 %). The lowest emergence was shown by the variety Camel (71.7%). Regarding tuber grades, it was noted that the maximum Ration size tubers were produced by the exotic variety Compass (3.7%), whereas 11 varieties did not produce ration size tubers at all. The variety Red Sun produced lowest percentage of small size tubers (12.7%) whereas maximum small size tubers (93.0%) were produced by the variety Jitka. Regarding disease infestation, it was noted that the maximum scab incidence (4.0%) was recorded on the variety Masai, maximum rhizoctonia attack (60.0%) was recorded on the variety Camel and maximum tuber cracking (0.7%) was noted on the variety Vendulla.

Keywords: check variety, potato, potential and yield, trial

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4644 Testing the Effectiveness of a Peer Facilitated Body Project Interventions Among Body Dissatisfied Young Women in China: A Randomized Control Trial

Authors: Todd Jackson

Abstract:

In this randomized control trial, we tested the effectiveness of a peer-facilitated version of the Body Project (BP) intervention among body-dissatisfied young women in China. Participants were randomly assigned to a peer-facilitator BP condition (N = 94) versus an educational video minimal intervention control condition (N = 89). Questionnaire measures of two primary outcomes (i.e., disordered eating and body dissatisfaction) and six secondary outcomes (thin-ideal internalization, pressure to be thin, negative affect, body surveillance, body shame, body appreciation and interest in cosmetic surgery) were administered at a pre-treatment baseline, a post-treatment assessment, and at a 12-month follow-up. A series of 2 (Group) x 2 (Time) analyses of variance indicated women in the peer-facilitated BP condition reported significant improvements in primary outcome measures of disordered eating and body dissatisfaction compared to women in the educational video control condition following treatment and at the 12-month follow-up. Furthermore, women in the peer-facilitated BP condition reported significant improvements in measures of body surveillance, body shame and body appreciation) compared to educational video controls that extended to the 12-month follow-up. Finally, although women in the peer-facilitated BP condition showed significant post-treatment improvements in thin-ideal internalization, negative affect, perceived pressure to be thin, and interest in cosmetic surgery compared to video controls, these differences were no longer statistically significant at the 12-month follow-up. In conclusion, findings supported the overall effectiveness of a peer-facilitated group version of the BP as an intervention for reducing disordered eating and several associated risk factors among at-risk young women in China.

Keywords: body project, disordered eating, body dissatisfaction, risk factors, prevention, China

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4643 Evaluation of the Effectiveness of the Argon Plasma Jet on Healing Process of the Wagner Grade 2 Diabetic Foot Ulcer

Authors: M. Khaledi Pour, P. Akbartehrani, M. Amini, M. Khani, M. Mohajeri Tehrani, R. Radi, B. Shokri

Abstract:

Diabetic Foot Ulcer (DFU) is one of the costly severe complications of diabetes. Neuropathy and Peripheral Arterial Disease (PAD) due to diabetes are significant causes of this complication. In 10 years the patients with DFUs are twice as likely to die as patients without DFUs. Cold Atmospheric Plasma (CAP) is a promising tool for medical purposes. CAP generate reactive species at room temperature and are effective in killing bacteria and fibroblast proliferation. These CAP-based tools produce NO, which has bactericidal and angiogenesis properties. It also showed promising effects in the DFUs surface reduction and the time to wound closure. In this paper, we evaluated the effect of the Argon Plasma Jet (APJ) on the healing process of the Wagner Grade 2 DFUs in a randomized clinical trial. The 20 kHz sinusoidal voltage frequency derives the APJ. Patients (n=20) were randomly double-blinded assigned into two groups. These groups receive the standard care (SC, n=10) and the standard care with APJ treatment (SC+APJ, n=10) for five sessions in four weeks. The results showed that the APJ treatment along standard care could reduce the wound surface by 20 percent more than the standard care. Also, It showed a more influential role in controlling wound infection.

Keywords: argon plasma jet, cold atmospheric plasma, diabetes, diabetic foot ulcer

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4642 Effectiveness of Mobile Health Augmented Cardiac Rehabilitation (MCard) on Health-Related Quality of Life among Post-Acute Coronary Syndrome Patients: A Randomized Controlled Trial

Authors: Aliya Hisam, Zia Ul Haq, Sohail Aziz, Patrick Doherty, Jill Pell

Abstract:

Objective: To determine the effectiveness of Mobile health augmented Cardiac rehabilitation (MCard) on health-related quality of life (HRQoL) among post-acute coronary syndrome(post-ACS) patients. Methodology: In a randomized controlled trial, post-ACS patients were randomly allocated (1:1) to an intervention group (received MCard; counseling, empowering with self-monitoring devices, short text messages, in addition to standard post-ACS care) or control group (standard post-ACS care). HRQoL was assessed by generic Short Form-12 and MacNew quality of life myocardial infarction (QLMI) tools. Participants were followed for 24 weeks with data collection and analysis at three-time points (baseline, 12 weeks and 24 weeks). Result: At baseline, 160 patients (80 in each group; mean age 52.66+8.46 years; 126 males, 78.75%) were recruited, of which 121(75.62%) continued and were analyzed at 12-weeks and 119(74.37%) at 24-weeks. The mean SF-12 physical component score significantly improved in the MCard group at 12 weeks follow-up (48.93 vs. control 43.87, p<.001) and 24 weeks (53.52 vs. 46.82 p<.001). The mean SF-12 mental component scores also improved significantly in the MCard group at 12 weeks follow-up (44.84 vs. control 41.40, p<.001) and 24 weeks follow-up (48.95 vs 40.12, p<.001). At 12-and 24-week follow-up, all domains of MacNew QLMI (social, emotional, physical and global) were also statistically significant (p<.001) improved in the MCard group, unlike the control group. Conclusion: MCard is feasible and effective at improving all domains of HRQoL. There was an improvement in physical, mental, social, emotional and global domains among the MCard group in comparison to the control group. The addition of MCard programs to post-ACS standard care may improve patient outcomes and reduce the burden on the health care setting.

Keywords: acute coronary syndrome, mobile health augmented cardiac rehabilitation (MCard), cardiovascular diseases, cardiac rehabilitation, health-related quality of life, short form 12, MacNew QLMI

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4641 Assessing the Impact of Pharmacist-Led Medication Therapy Management on Treatment Adherence and Clinical Outcomes in Cancer Patients: A Prospective Intervention Study

Authors: Omer Ibrahim Abdallh Omer

Abstract:

Cancer patients often face complex medication regimens, leading to challenges in treatment adherence and clinical outcomes. Pharmacist-led medication therapy management (MTM) has emerged as a potential solution to optimize medication use and improve patient outcomes in oncology settings. In this prospective intervention study, we aimed to evaluate the impact of pharmacist-led MTM on treatment adherence and clinical outcomes among cancer patients. Participants were randomized to receive either pharmacist-led MTM or standard care, with assessments conducted at baseline and follow-up visits. Pharmacist interventions included medication reconciliation, adherence counseling, and personalized care plans. Our findings reveal that pharmacist-led MTM significantly improved medication adherence rates and clinical outcomes compared to standard care. Patients receiving pharmacist interventions reported higher satisfaction levels and perceived value in pharmacist involvement in their cancer care. These results underscore the critical role of pharmacists in optimizing medication therapy and enhancing patient-centered care in oncology settings. Integration of pharmacist-led MTM into routine cancer care pathways holds promise for improving treatment outcomes and quality of life for cancer patients.

Keywords: cancer, medications adherence, medication therapy management, pharmacist

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4640 Combined Mindfulness and Exercise Intervention for Depressive and Insomnia Symptoms in Chinese Students: A Pilot Randomized Controlled Trial

Authors: Xinli Chi, Xiaoqi Wei

Abstract:

Background: Body-mind theory refers to the concept that the mind and body are interconnected; in this case, combining aerobic exercise and mindfulness-based training may be beneficial for mind-body health; however, there is limited evidence regarding their effects and potential mechanisms among Chinese university students. Therefore, the current study aims to examine the preliminary effects and feasibility of the combined intervention on depressive and insomnia symptoms, as well as to explore the underlying mechanisms. Methods: This is a two-arm pilot study of a randomized, controlled trial. Sixty-one Chinese university students were randomly allocated to 8-week combined intervention group (aerobic exercise plus mindfulness, N = 36) or control group (N = 36). In addition, 8 participants in combined intervention group were later volunteer to engage in semi-structured interview. The Self-Rating Depression Scale (SDS) and the Youth Self-Rating Insomnia Scales (YSIS) were used to measure depressive and insomnia symptoms, respectively. The intervention outcome and feasibility were tested by repeated-measures ANOVA, mediation model, and qualitative analysis. Results: The study included 31 participants in the intervention group and 30 participants in the control group, all of whom completed pre-test and post-test questionnaires. The results of the repeated-measures ANOVA showed that the combined intervention was effective in reducing depressive and insomnia symptoms among university students. Moreover, the mediation analysis suggested that improvement in insomnia symptoms might be a significant mechanism for the combined intervention. Qualitative analysis identified two main themes: “Helpful aspects of mind-body state” (including 7 sub-themes) and “Factors that influence the training effects” (including 3 sub-themes). Conclusions: The study confirmed the preliminary effect and feasibility of the combined intervention of mindfulness and aerobic exercise, while also exploring the potential mechanisms underlying this effect. Additionally, qualitative data provided valuable insights for optimizing future protocols.

Keywords: combined intervention, mindfulness, aerobic exercise, depressive symptoms, insomnia symptoms

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4639 Efficacy of Topical Ectoin Therapy for Acute Radiodermatitis Associated with Breast Cancer Radiotherapy: A Randomized Controlled Study

Authors: Nagwa E. Abd Elazim, Maha S. El-naggar, Rania H. Mohamed, Sara M. Awad

Abstract:

Background: Radiodermatitis is a common side effect of radiation therapy for breast cancer. However, there is no current consensus about effective standard therapy for the prevention and management of radiation dermatitis. Topical ectoine has demonstrated efficacy in the treatment of atopic dermatitis owing to its anti-inflammatory activity. Objective: To evaluate the efficacy of topical ectoine in comparison to traditional topical dexpanthenol treatment in the management of acute radiodermatitis in breast cancer patients undergoing adjuvant radiotherapy. Methods: Fifty patients were randomized to use either dexpanthenol 0.5% cream (25 patients), or ectoin 7% cream (25 patients), applied twice daily to the irradiated area during the radiation period and continued for 2 weeks after cessation of radiotherapy. Assessment of radiation skin toxicity using Common Terminology Criteria of Adverse Events (CTCAE) v4.0, radiation-associated symptoms, and adverse events were undertaken weekly during radiotherapy and 2 weeks after the end of radiotherapy. Results: Topical ectoine showed some clinical benefit over dexpanthenol, as shown by delayed time to onset (at week 3 versus week 2, respectively) and larger number of patients who reached grade 0 at the end of treatment (64% vs. 48%, respectively). The clinical symptoms of pain (p = 0.003) and itching (p = 0.001) attributable to radiation were less pronounced with ectoine than with dexpanthenol. Burning and hyperpigmentation were the most common side effects with ectoine. However, no significant difference between dexpanthenol and ectoine treatments was found in any of the side effects (p = 0.1). Conclusion: Ectoin was overall more effective in improving radiation dermatitis than topical dexpanthenol in breast cancer patients. Ectoin could be proposed as a preventive or curative treatment for patients undergoing postoperative irradiation for breast cancer. Further clinical studies with a larger number of patients are recommended for the confirmation of these preliminary results.

Keywords: breast cancer, dexapanthenol, ectoin, radiation dermatitis

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4638 Methylphenidate and Placebo Effect on Brain Activity and Basketball Free Throw: A Randomized Controlled Trial

Authors: Mohammad Khazaei, Reza Rostami, Hasan Gharayagh Zandi, Rouhollah Basatnia, Mahbubeh Ghayour Najafabadi

Abstract:

Objective: Methylphenidate has been demonstrated to enhance attention and cognitive processes, and placebo treatments have also been found to improve attention and cognitive processes. Additionally, methylphenidate may have positive effects on motion perception and sports performance. Nevertheless, additional research is needed to fully comprehend the neural mechanisms underlying the effects of methylphenidate and placebo on cognitive and motor functions. Methods: In this randomized controlled trial, 18 young semi-professional basketball players aged 18-23 years were randomly and equally assigned to either a Ritalin or Placebo group. The participants performed 20 consecutive free throws; their scores were recorded on a 0-3 scale. The participants’ brain activity was recorded using electroencephalography (EEG) for 5 minutes seated with their eyes closed. The Ritalin group received a 10 mg dose of methylphenidate, while the Placebo group received a 10mg dose of placebo. The EEG was obtained 90 minutes after the drug was administere Results: There was no significant difference in the absolute power of brain waves between the pre-test and post-tests in the Placebo group. However, in the Ritalin group, a significant difference in the absolute power of brain waves was observed in the Theta band (5-6 Hz) and Beta band (21-30 Hz) between pre- and post-tests in Fp2, F8, and Fp1. In these areas, the absolute power of Beta waves was higher during the post-test than during the pre-test. The Placebo group showed a more significant difference in free throw scores than the Ritalin group. Conclusions: In conclusion, these results suggest that Ritalin effect on brain activity in areas associated with attention and cognitive processes, as well as improve basketball free throws. However, there was no significant placebo effect on brain activity performance, but it significantly affected the improvement of free throws. Further research is needed to fully understand the effects of methylphenidate and placebo on cognitive and motor functions.

Keywords: methylphenidate, placebo effect, electroencephalography, basketball free throw

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4637 A Randomized Controlled Trial Study on the Effect of Adding Dexmedetomidine to Bupivacaine in Supraclavicular Block Using Ultrasound Guidance

Authors: Nazia Nazir

Abstract:

Background: The benefits of regional anesthetic techniques are well established. Use of additives to local anesthetics can prolong these benefits. The aim of this study was to observe the effect of adding dexmedetomidine to bupivacaine for the supraclavicular block. Methods (Design): In this randomized, double-blind study, seventy ASA I & II patients of either sex undergoing elective surgeries on the upper limb were given supraclavicular block under ultrasound guidance. Group C (n=35), received 38 mL 0.25% bupivacaine + 2mL normal saline and group D received 38 mL 0.25% bupivacaine + 1 µg/kg dexmedetomidine (2mL). Patients were observed for onset, duration of motor and sensory block, duration of analgesia, sedation score, hemodynamic changes and any adverse events. Results: In group D the onset was faster (P < 0.001), duration of sensory and motor block, as well as duration of analgesia, was prolonged as compared to group C (P < 0.0001). There was significant drop in heart rate (HR) from the baseline in group D (P < 0.05) at 30, 60, 90 and 120 min, however, none of the patients dropped HR below 50/min. Mean arterial Pressure (MAP) remained unaffected. The patients in group D were effectively sedated than those in group C (P < 0.05). No adverse event was reported in either group. Conclusion: Dexmedetomidine as adjuvant to bupivacaine in supraclavicular block resulted in faster action, prolonged motor and sensory block, prolonged analgesia with hemodynamic stability and adequate sedation.

Keywords: Analgesia, bupivacaine, dexmedetomidine, supraclavicular block

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4636 Rethinking the Pre-Trial Detention Law of Ethiopia: An International Law and Constitutional Law Perspective

Authors: Addisu Teshama

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The existing criminal procedure law which is the main determinant of the phenomena of pre-trial detention is under revision in Ethiopia. The drafting work is completed and submitted for approval to the House of Peoples Representatives. The drafters of the draft law claim that the existing law is not in harmony with the constitutionally and internationally recognized principles pertinent to pretrial detention regulation. Further, the drafters allege that the drafting process is dictated by human rights principles recognized in the FDRE constitution and international human rights instruments ratified by Ethiopia. This article aims to the asses the plausibility of the claims of the drafters. For that purpose, this article uses the standards and guidelines articulated by international human rights standard setters as bench marks to juxtapose and judge the existing law and the draft criminal procedure and evidence code (DCrimPEC). The study found that the many aspects of the pre-trial detention law of Ethiopia are not in compliance with international law standards in the existing criminal procedure law. The DCrimPEC is aimed to harmonize the existing law with the constitution and international law standards. In this regard, the study found that the DCrimPEC has made significant changes on pre-trial detention policies which are not in harmony the principle of presumption of innocence. However, there are still gaps.

Keywords: pre-trial detention, right to personal liberty, right to bail, Ethiopia

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4635 The Effectiveness of Psychosocial Intervention in Reducing Career Anxiety among Nigerian University Students

Authors: Mkpoikanke Sunday Otu

Abstract:

Introduction: Career anxiety is a common issue among university students, particularly in developing countries like Nigeria. This anxiety can significantly impact students' academic performance, overall well-being, and future career prospects. Therefore, it is crucial to explore effective interventions that can alleviate career anxiety among university students. The primary aim of this study was to determine the effectiveness of a psychosocial intervention in reducing career anxiety among Nigerian university students. The study employed a group randomized trial research design to further analyze the impact on career anxiety. Methodology: A total of 306 university students from various universities in Akwa Ibom State, Nigeria, were recruited for this study. The participants were purposively selected to ensure diversity and represent a range of academic disciplines. A group randomized trial research design was employed, with participants randomly assigned to either the treatment group or the control group. The treatment group received a comprehensive psychosocial intervention, while the control group served as a comparison group. The Career Anxiety Questionnaire (CAQ) was used to assess career anxiety levels among the participants. The CAQ is a validated and reliable tool that assesses various aspects of career-related anxiety, including uncertainty, fear, and self-doubt. It was administered to the participants at baseline (before the intervention), immediately after the intervention, and at follow-up (after the intervention). Results: Data analysis was conducted using statistical techniques, including analysis of variance (ANOVA). The results demonstrated that the treatment group showed a significantly lower mean score of career anxiety compared to the control group (p-value<0.05). This finding suggests that the psychosocial intervention was effective in reducing the career anxiety levels of the participants at post-test and follow-up. Conclusion: The findings of this study provide compelling evidence that psychosocial interventions have a significant impact on the reduction of career anxiety among Nigerian university students. The treatment group demonstrated a significant reduction in career anxiety scores, indicating the effectiveness of this intervention. Additionally, this study highlights the importance of addressing the career anxiety challenges faced by university students. By implementing targeted interventions, educational institutions can play a vital role in supporting the overall well-being and success of their students, both academically and professionally.

Keywords: psychosocial intervention, career anxiety, psychoeducation, university students

Procedia PDF Downloads 32
4634 Validation of a Placebo Method with Potential for Blinding in Ultrasound-Guided Dry Needling

Authors: Johnson C. Y. Pang, Bo Peng, Kara K. L. Reeves, Allan C. L. Fud

Abstract:

Objective: Dry needling (DN) has long been used as a treatment method for various musculoskeletal pain conditions. However, the evidence level of the studies was low due to the limitations of the methodology. Lack of randomization and inappropriate blinding is potentially the main sources of bias. A method that can differentiate clinical results due to the targeted experimental procedure from its placebo effect is needed to enhance the validity of the trial. Therefore, this study aimed to validate the method as a placebo ultrasound(US)-guided DN for patients with knee osteoarthritis (KOA). Design: This is a randomized controlled trial (RCT). Ninety subjects (25 males and 65 females) aged between 51 and 80 (61.26 ± 5.57) with radiological KOA were recruited and randomly assigned into three groups with a computer program. Group 1 (G1) received real US-guided DN, Group 2 (G2) received placebo US-guided DN, and Group 3 (G3) was the control group. Both G1 and G2 subjects received the same procedure of US-guided DN, except the US monitor was turned off in G2, blinding the G2 subjects to the incorporation of faux US guidance. This arrangement created the placebo effect intended to permit comparison of their results to those who received actual US-guided DN. Outcome measures, including the visual analog scale (VAS) and Knee injury and Osteoarthritis Outcome Score (KOOS) subscales of pain, symptoms, and quality of life (QOL), were analyzed by repeated measures analysis of covariance (ANCOVA) for time effects and group effects. The data regarding the perception of receiving real US-guided DN or placebo US-guided DN were analyzed by the chi-squared test. The missing data were analyzed with the intention-to-treat (ITT) approach if more than 5% of the data were missing. Results: The placebo US-guided DN (G2) subjects had the same perceptions as the use of real US guidance in the advancement of DN (p<0.128). G1 had significantly higher pain reduction (VAS and KOOS-pain) than G2 and G3 at 8 weeks (both p<0.05) only. There was no significant difference between G2 and G3 at 8 weeks (both p>0.05). Conclusion: The method with the US monitor turned off during the application of DN is credible for blinding the participants and allowing researchers to incorporate faux US guidance. The validated placebo US-guided DN technique can aid in investigations of the effects of US-guided DN with short-term effects of pain reduction for patients with KOA. Acknowledgment: This work was supported by the Caritas Institute of Higher Education [grant number IDG200101].

Keywords: ultrasound-guided dry needling, dry needling, knee osteoarthritis, physiotheraphy

Procedia PDF Downloads 94
4633 Evaluation of the Effect of Intravenous Dexamethasone on Hemodynamic Variables and Hypotension in Female Undergoing Cesarean Section With Spinal Anesthesia

Authors: Shekoufeh Behdad, Sahar Yadegari, Alireza Ghehrazad, Amirhossein Yadegari

Abstract:

Background: In this study, we compared the effect of intravenous dexamethasone with placebo on hemodynamic variables and hypotension in patients undergoing cesarean section under spinal anesthesia. Materials and methods: This double-blind, randomized clinical trial was conducted with the approval of the university ethics committee. Written informed consent was obtained from all participating patients. Before spinal anesthesia, patients were randomly assigned to receive either dexamethasone (8 mg IV) or placebo (normal saline). Hemodynamic variables, including systolic, diastolic, and mean arterial blood pressures, as well as heart rate, were measured before drug administration and every 3 minutes until the birth of the neonate and then every 5 minutes until the end of surgery. Side effects such as hypotension, bradycardia, nausea, and vomiting were assessed and recorded for all the patients. Results: There were no significant differences in mean systolic, diastolic, and mean arterial blood pressures before and after administration of the studied drugs in both groups (P.Value>0.05), but heart rate and the incidence of hypotension in the dexamethasone group were less than placebo significantly. Conclusions: Intravenous administration of 8 mg dexamethasone before spinal anesthesia in females undergoing cesarean section can reduce the incidence of post-spinal hypotension without causing serious side effects.

Keywords: cesarean section, hypotension, spinal anesthesia, dexamethasone

Procedia PDF Downloads 53
4632 The Role of Vitamin D Supplementation in Augmenting IFN-γ Production in Response to Mycobacterium Tuberculosis Infection: A Randomized Controlled Trial

Authors: Muhammad Imran Hussain, Ramisha Ibtisam, Tayyaba Fatima, Huba Khalid, Ayesha Aziz, Khansa, Adan Sitara, Anam Shahzad, Aymen Jabeen

Abstract:

Vitamin D supports the immune system fight TB by inhibiting Interferon-gamma (IFN-γ) and lowering host inflammation. The purpose of the research was to see if giving the vitamin D supplements to TB patients affected their prognosis. A randomized placebo control study of 200 TB patients was performed among which 106 received 400,000 IU of injectable vitamin D3 and 94 received placebo for 2 doses. Assessment was carried out at the end of every month for 3 months. IFN-γ responses to whole blood stimulation generated by the Mycobacterium tuberculosis sonicate (MTBs) antigen and early secreted and T cell activated 6 kDa (ESAT6) were assessed at 0 and 12 weeks. The statistical analysis used descriptive statistics (mean and standard deviation), Friedman's test and Fisher's test. The vitamin D group gained significantly more weight (+3.90 pounds) and had less persistent lung disease on imaging (1.33 zones vs. 1.84 zones). They also had a 50% decrease in cavity size. Additionally, patients with low baseline serum concentrations of 25-(OH)D had a significant increase in MTB-induced IFN-γ production after taking vitamin D supplements. Vitamin D administration in large amounts can hasten the recovery of TB patients. The findings point is a therapeutically useful activity of Vitamin D's in the management for tuberculosis.

Keywords: tuberculosis, vitamin D, interferon gamma, protein, infection

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4631 A Randomised Controlled Trial on the Nurse-Led Smartphone-Based Self-Management Programme for Type 2 Diabetes Patients with Poor Glycemic Control

Authors: Wenru Wang

Abstract:

Over the past decades, Asia has emerged as the ‘diabetes epicentre’ in the world due to rapid economic development, urbanization and nutrition transition. There is an urgent need to develop more effective and cost-effective care management strategies in response to this rising diabetes epidemic. This study aims to develop and compare a nurse-led smartphone-based self-management programme with an existing nurse-led diabetes service on health-related outcomes among type 2 diabetes patients with poor glycemic control in Singapore. We proposed a randomized controlled trial with pre- and repeated post-tests control group design. A total of 128 type 2 diabetes patients with poor glycemic control will be recruited from the diabetes clinic of an acute public hospital in Singapore through convenience sampling. Study participants will be either randomly allocated to the experimental group or control group. Outcome measures used will include the 10-item General Self-Efficacy Scale, 11-item Revised Summary of Diabetes Self-care Activities, and 19-item Diabetes-Dependent Quality of Life. Data will be collected at 3-time points: baseline, three months and six months from the baseline, respectively. It is expected that this programme will be an alternative offered to diabetes patients to master their self-care management skills, in addition to the existing diabetes service provided in diabetes clinics in Singapore hospitals. Also, the self-supporting and less resource-intensive nature of this programme, through the use of smartphone app as a mode of intervention delivery, will greatly reduce nurses’ direct contact time with patients and allow more time to be allocated to those who require more attention. The study has been registered with clinicaltrials.gov. The trial registration number is NCT03088475.

Keywords: type 2 diabetes, poor glycaemic control, nurse-led, smartphone-based, self-management, health-relevant outcomes

Procedia PDF Downloads 171
4630 Creatine Associated with Resistance Training Increases Muscle Mass in the Elderly

Authors: Camila Lemos Pinto, Juliana Alves Carneiro, Patrícia Borges Botelho, João Felipe Mota

Abstract:

Sarcopenia, a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength, currently affects over 50 million people and increases the risk of adverse outcomes such as physical disability, poor quality of life and death. The aim of this study was to examine the efficacy of creatine supplementation associated with resistance training on muscle mass in the elderly. A 12-week, double blind, randomized, parallel group, placebo controlled trial was conducted. Participants were randomly allocated into one of the following groups: placebo with resistance training (PL+RT, n=14) and creatine supplementation with resistance training (CR + RT, n=13). The subjects from CR+RT group received 5 g/day of creatine monohydrate and the subjects from the PL+RT group were given the same dose of maltodextrin. Participants were instructed to ingest the supplement on non-training days immediately after lunch and on training days immediately after resistance training sessions dissolved in a beverage comprising 100 g of maltodextrin lemon flavored. Participants of both groups undertook a supervised exercise training program for 12 weeks (3 times per week). The subjects were assessed at baseline and after 12 weeks. The primary outcome was muscle mass, assessed by dual energy X-ray absorptiometry (DXA). The secondary outcome included diagnose participants with one of the three stages of sarcopenia (presarcopenia, sarcopenia and severe sarcopenia) by skeletal muscle mass index (SMI), handgrip strength and gait speed. CR+RT group had a significant increase in SMI and muscle (p<0.0001), a significant decrease in android and gynoid fat (p = 0.028 and p=0.035, respectively) and a tendency of decreasing in body fat (p=0.053) after the intervention. PL+RT only had a significant increase in SMI (p=0.007). The main finding of this clinical trial indicated that creatine supplementation combined with resistance training was capable of increasing muscle mass in our elderly cohort (p=0.02). In addition, the number of subjects diagnosed with one of the three stages of sarcopenia at baseline decreased in the creatine supplemented group in comparison with the placebo group (CR+RT, n=-3; PL+RT, n=0). In summary, 12 weeks of creatine supplementation associated with resistance training resulted in increases in muscle mass. This is the first research with elderly of both sexes that show the same increase in muscle mass with a minor quantity of creatine supplementation in a short period. Future long-term research should investigate the effects of these interventions in sarcopenic elderly.

Keywords: creatine, dietetic supplement, elderly, resistance training

Procedia PDF Downloads 455
4629 Cytokine Changes of Auricular Point Acupressure to Manage Aromatase Inhibitor-Induced Arthralgia in Postmenopausal Breast Cancer Survivors

Authors: Chao Hsing Yeh, Wei Chun Lin

Abstract:

Background: Current management of aromatase inhibitor-induced arthralgia (AIA) in postmenopausal breast cancer survivors (PBCS) has limited effect. Method: In this prospective randomized clinical trial (RCT), a 4-week APA treatment was used to manage AIA. Twenty PBCS participated. After baseline data was collected, participants were waited for a month before they receive APA at a convenient time once a week for 4 weeks. Blood samples from participants in both groups were collected at baseline and after 4 weeks of treatment. The primary outcomes included: pain intensity, pain interference, stiffness, and physical function. Results: After the 4-week APA treatment, the pro-inflammatory cytokines and chemokines display a trend of mean percentage reduction (i.e., -22% in IL-1α, -4% in IL-1β, -1% in IL-2, -3% in IL-6, -19% in IL-12, -9% in Eotaxin, and -2% in MCP-1). The anti-inflammatory cytokine IL-10 and IL-13 (i.e., 5% in IL-10 and 29% in IL-13) increased from pre- to post-APA treatment. Significant positive correlation of percentage mean change was observed between symptom severity and eotaxin (ρ = 0.56; p < 0.01) & MCP-1 (ρ = 0.65; p < 0.01). Interference and chemokines (eotaxin & MIP-1) also shows positive correlation (ρ = 0.48; p < 0.01 & ρ = 0.39; p < 0.05). Another positive correlation was found between worst pain and chemokines (eotaxin, ρ = 0.48; p < 0.01 & MIP-1, ρ = 0.39; p < 0.05). Additionally, interference also shows positive correlation among IL-1α (ρ = 0.36; p < 0.05) and IL-β (ρ = 0.33; p < 0.05). Conclusion: These findings suggest that APA intervention may inhibit inflammation of AIA patients and chemokine could be one of the key factors of AIA symptom improvement.

Keywords: acupressure, cytokine, pain management, breast cancer survivors

Procedia PDF Downloads 241
4628 Validation of a Placebo Method with Potential for Blinding in Ultrasound-Guided Dry Needling

Authors: Johnson C. Y. Pang, Bo Pengb, Kara K. L. Reevesc, Allan C. L. Fud

Abstract:

Objective: Dry needling (DN) has long been used as a treatment method for various musculoskeletal pain conditions. However, the evidence level of the studies was low due to the limitations of the methodology. Lack of randomization and inappropriate blinding are potentially the main sources of bias. A method that can differentiate clinical results due to the targeted experimental procedure from its placebo effect is needed to enhance the validity of the trial. Therefore, this study aimed to validate the method as a placebo ultrasound(US)-guided DN for patients with knee osteoarthritis (KOA). Design: This is a randomized controlled trial (RCT). Ninety subjects (25 males and 65 females) aged between 51 and 80 (61.26±5.57) with radiological KOA were recruited and randomly assigned into three groups with a computer program. Group 1 (G1) received real US-guided DN, Group 2 (G2) received placebo US-guided DN, and Group 3 (G3) was the control group. Both G1 and G2 subjects received the same procedure of US-guided DN, except the US monitor was turned off in G2, blinding the G2 subjects to the incorporation of faux US guidance. This arrangement created the placebo effect intended to permit comparison of their results to those who received actual US-guided DN. Outcome measures, including the visual analog scale (VAS) and Knee injury and Osteoarthritis Outcome Score (KOOS) subscales of pain, symptoms and quality of life (QOL), were analyzed by repeated-measures analysis of covariance (ANCOVA) for time effects and group effects. The data regarding the perception of receiving real US-guided DN or placebo US-guided DN were analyzed by the chi-squared test. The missing data were analyzed with the intention-to-treat (ITT) approach if more than 5% of the data were missing. Results: The placebo US-guided DN (G2) subjects had the same perceptions as the use of real US guidance in the advancement of DN (p<0.128). G1 had significantly higher pain reduction (VAS and KOOS-pain) than G2 and G3 at 8 weeks (both p<0.05) only. There was no significant difference between G2 and G3 at 8 weeks (both p>0.05). Conclusion: The method with the US monitor turned off during the application of DN is credible for blinding the participants and allowing researchers to incorporate faux US guidance. The validated placebo US-guided DN technique can aid in investigations of the effects of US-guided DN with short-term effects of pain reduction for patients with KOA. Acknowledgment: This work was supported by the Caritas Institute of Higher Education [grant number IDG200101].

Keywords: reliability, jumping, 3D motion analysis, anterior crucial ligament reconstruction

Procedia PDF Downloads 102
4627 The Comparison of the Effect of Mindfulness-Based Relaxation Training and Trans Cranial Electrical Stimulation and Their Combination on Decreasing Physiological Distress in Patients with Type-2 Diabetes

Authors: Gholam Hossein Javanmard, Roghayeh Mohammadi Garegozlo

Abstract:

The present study was a randomized three-group double-blind clinical trial with repeated measures designs which aimed to determine the pure effect and combined effect of mindfulness based-relaxation (MBR) technique and Transcranial Electrical Simulation (tCES) on psychological distress decreasing of patients with type-2 diabetes. The sample of the study consisted of 30 patients with type-2 diabetes who were selected from the Diabetes Association of Bonab city in Iran. The participants were matched and then randomly assigned to the three groups of 10 subjects (MBR, CES, MBR+CES). The subjects received interventions related to their group in 10 individual sessions. Pre-test, post-test, and one-month follow-up were conducted using DASS-42. Analysis of variance with repeated measures showed a significant change in psychological distress. Multivariate covariance analysis and the paired interpersonal comparative test of Ben Foruni indicated that both interventions of MBR and CES have a similar effect on psychological distress decreasing in the post-test and follow-up phase. But, the combined therapy of MBR+CES was more efficient, and it had a more stable effect. However, all three interventions, especially combined intervention of MBR+CES, as efficient and stable treatment, are suggested for improving the psychological status of diabetic patients.

Keywords: mindfulness based-relaxation, transcranial electrical simulation, type 2 diabetes, psychological distress

Procedia PDF Downloads 116
4626 Feasibility and Acceptability of Mindfulness-Based Cognitive Therapy in People with Depression and Cardiovascular Disorders: A Feasibility Randomised Controlled Trial

Authors: Modi Alsubaie, Chris Dickens, Barnaby Dunn, Andy Gibson, Obioha Ukoumunned, Alison Evans, Rachael Vicary, Manish Gandhi, Willem Kuyken

Abstract:

Background: Depression co-occurs in 20% of people with cardiovascular disorders, can persist for years and predicts worse physical health outcomes. While psychosocial treatments have been shown to effectively treat acute depression in those with comorbid cardiovascular disorders, to date there has been no evaluation of approaches aiming to prevent relapse and treat residual depression symptoms in this group. Therefore, the current study aimed to examine the feasibility and acceptability of a randomised controlled trial design evaluating an adapted version of mindfulness-based cognitive therapy (MBCT) designed specifically for people with co-morbid depression and cardiovascular disorders. Methods: A 3-arm feasibility randomised controlled trial was conducted, comparing MBCT adapted for people with cardiovascular disorders plus treatment as usual (TAU), mindfulness-based stress reduction (MBSR) plus TAU, and TAU alone. Participants completed a set of self-report measures of depression severity, anxiety, quality of life, illness perceptions, mindfulness, self-compassion and affect and had their blood pressure taken immediately before, immediately after, and three months following the intervention. Those in the adapted-MBCT arm additionally underwent a qualitative interview to gather their views about the adapted intervention. Results: 3400 potentially eligible participants were approached when attending an outpatient appointment at a cardiology clinic or via a GP letter following a case note search. 242 (7.1%) were interested in taking part, 59 (1.7%) were screened as being suitable, and 33 (<1%) were eventually randomised to the three groups. The sample was heterogeneous in terms of whether they reported current depression or had a history of depression and the time since the onset of cardiovascular disease (one to 25 years). Of 11 participants randomised to adapted MBCT seven completed the full course, levels of home mindfulness practice were high, and positive qualitative feedback about the intervention was given. Twenty-nine out of 33 participants randomised completed all the assessment measures at all three-time points. With regards to the primary outcome (depression), five out of the seven people who completed the adapted MBCT and three out of five under MBSR showed significant clinical change, while in TAU no one showed any clinical change at the three-month follow-up. Conclusions: The adapted MBCT intervention was feasible and acceptable to participants. However, aspects of the trial design were not feasible. In particular, low recruitment rates were achieved, and there was a high withdrawal rate between screening and randomisation. Moreover, the heterogeneity in the sample was high meaning the adapted intervention was unlikely to be well tailored to all participants needs. This suggests that if the decision is made to move to a definitive trial, study recruitment procedures will need to be revised to more successfully recruit a target sample that optimally matches the adapted intervention.

Keywords: mindfulness-based cognitive therapy (MBCT), depression, cardiovascular disorders, feasibility, acceptability

Procedia PDF Downloads 194
4625 The Effect of Aerobic Exercise Training on the Improvement of Nursing Staff's Sleep Quality: A Randomized Controlled Study

Authors: Niu Shu Fen

Abstract:

Sleep disturbance is highly prevalent among shift-working nurses. We aimed to evaluate whether aerobic exercise (i.e., walking combined with jogging) improves objective Sleepparameters among female nurses at the end of an 8-week exercise program and 4 weeks after study completion. This single-blinded, parallel design, randomized controlled trial was conducted in the floor classroom of a would-be medical center in northern Taiwan. Sixtyeligible female nurses were randomly assigned to either aerobic exercise (n = 30) or usual care (n = 30) group. The moderate-intensity aerobic exercise program was performed over 5days (60 min per day) a week for 8 weeks after work hours. Objective sleep outcomes including total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), and sleep efficiency (SE), were retrieved using an Actigraph device. A generalized estimated equation model was used for data analyses. The aerobic exercise group had significant improvements in TST and SE at 4 weeks and 8 weeks compared with baseline evaluation(TST: B = 70.49 and 55.96, both p < 0.001; SE: B = 5.21 and 3.98, p < 0.001 and 0.002).Significant between-group differences were observed in SOL and WASO at 4 weeks but not8 weeks compared with the baseline evaluation (SOL: B = −7.18, p = 0.03; WASO: B =−11.38, p = 0.008). The positive lasting effects for TST were observed only until the 4-week follow-up. To improve sleep quality and quantity, we encourage female nurses to regularly perform moderate-intensity aerobic exercise.

Keywords: sleep quality, aerobic exercise, nurses, shift work

Procedia PDF Downloads 128
4624 The Effect of Newspaper Reporting on COVID-19 Vaccine Hesitancy: A Randomised Controlled Trial

Authors: Anna Rinaldi, Pierfrancesco Dellino

Abstract:

COVID-19 vaccine hesitancy can be observed at different rates in different countries. In June 2021, 1,068 people were surveyed in France and Italy to inquire about individual potential acceptance, focusing on time preferences in a risk-return framework: having the vaccination today, in a month, and in 3 months; perceived risks of vaccination and COVID-19; and expected benefit of the vaccine. A randomized controlled trial was conducted to understand how everyday stimuli like fact-based news about vaccines impact an audience's acceptance of vaccination. The main experiment involved two groups of participants and two different articles about vaccine-related thrombosis taken from two Italian newspapers. One article used a more abstract description and language, and the other used a more anecdotal description and concrete language; each group read only one of these articles. Two other groups were assigned categorization tasks; one was asked to complete a concrete categorization task, and the other an abstract categorization task. Individual preferences for vaccination were found to be variable and unstable over time, and individual choices of accepting, refusing, or delaying could be affected by the way news is written. In order to understand these dynamic preferences, the present work proposes a new model based on seven categories of human behaviors that were validated by a neural network. A treatment effect was observed: participants who read the articles shifted to vaccine hesitancy categories more than participants assigned to other treatments and control. Furthermore, there was a significant gender effect, showing that the type of language leading to a lower hesitancy rate for men is correlated with a higher hesitancy rate for women and vice versa. This outcome should be taken into consideration for an appropriate gender-based communication campaign aimed at achieving herd immunity. The trial was registered at ClinicalTrials.gov NCT05582564 (17/10/2022).

Keywords: vaccine hesitancy, risk elicitation, neural network, covid19

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4623 Clinical Outcomes of Critically Ill Patients with Sepsis Receiving Extended and Standard Meropenem Infusion in Malaysian Hospitals

Authors: Fahmi Hassan, Noorizan Abdul Aziz, Yahaya Hassan, Hazlinda Abu Hassan

Abstract:

Sepsis incidence in critical care settings is a major problem in health care. Extended antibiotic infusion is thought to be superior to traditional dosing especially when treating critically ill patients with sepsis. We compared clinical outcomes of critically ill patients with sepsis receiving 30-minute meropenem infusion and three-hour meropenem infusion. A retrospective case-control study was conducted among septic patients treated with meropenem infusion in ICUs of three hospitals. Patients included in the study received either extended or standard meropenem infusion as per the practice of individual settings. Outcomes and clinical data were retrospectively collected from the electronic databases and patients’ files. A total of 108 patients received extended meropenem infusion while another 117 patients received standard meropenem infusion. Patients receiving the extended meropenem infusion were found to have a significantly lower shorter length of hospital and ICU stay. It was also found that among those receiving extended meropenem infusion, 54.7% (64/117) had a reduction of SAPS II score, while only 44% (48/108) of patients receiving standard meropenem infusion had reduced scores. This study will strengthen the evidence in using extended meropenem infusion as a standard practice in critical care settings. As this is the first study of its kind done in Malaysia, it proves that prolonged meropenem infusion may be beneficial to critically ill patients with sepsis. However, randomized clinical trials with large sample size should be carried out in local settings in order to minimize other confounders that may influence with the result of the study.

Keywords: antibiotics, beta lactams, critical care, extended infusion, meropenem

Procedia PDF Downloads 379