Search results for: randomized trial

Authors: Kasra Afsahi, Maryam Soheilifar, S. Hossein Hosseini, Omid Seyed Esmaeili, Rouzbeh Kezemi, Noushin Mehrbod, Nazanin Vahed, Tahereh Hajiahmad, Noureddin Nakhostin Ansari

Abstract:

Background: Stroke is a disabling neurological disease. Rehabilitative therapies are important treatment methods. This clinical trial was done to compare the effects of VR beside conventional rehabilitation versus conventional rehabilitation alone on spasticity and motor function in stroke patients. Materials and Methods: In this open-label randomized controlled clinical trial, 40 consecutive patients with stable first-ever ischemic stroke in the past three to 12 months that were referred to a rehabilitation clinic in Tehran, Iran, in 2020 were enrolled. After signing the informed written consent form, subjects were randomly assigned by block randomization of five in each block as cases with 1:1 into two groups of 20 cases; conventional plus VR therapy group: 45-minute conventional therapy session plus 15-minute VR therapy, and conventional group: 60-minute conventional therapy session. VR rehabilitation is designed and developed with different stages. Outcomes were modified Ashworth scale, recovery stage score for motor function, range of motion (ROM) of shoulder abduction/wrist extension, and patients’ satisfaction rate. Data were compared after study termination. Results: The satisfaction rate among the patients was significantly better in the combination group (P=0.003). Only wrist extension was varied between groups and was better in the combination group. The variables generally had a statistically significant difference (P < 0.05). Conclusion: Virtual reality plus conventional rehabilitation therapy is superior versus conventional rehabilitation alone on the wrist and elbow spasticity and motor function in patients with stroke.

Keywords: stroke, virtual therapy, rehabilitation, treatment

Procedia PDF Downloads 187

Authors: Teris Cheung, Joyce Yuen Ting Lam, Kwan Hin Fong, Yuen Shan Ho, Tim Man Ho Li, Andy Choi-Yeung Tse, Cheng-Ta Li, Calvin Pak-Wing Cheng, Roland Beisteiner

Abstract:

Transcranial pulse stimulation (TPS) is a non-intrusive brain stimulation technology that has been proven effective in older adults with mild neurocognitive disorders and adults with major depressive disorder. Given these robust evidences, TPS might be an adjunct treatment options in neuropsychiatric disorders, for example, autism spectrum disorder (ASD) – which is a common neurodevelopmental disorder in children. This trial aimed to investigate the effects of TPS on right temporoparietal junction, a key node for social cognition for Autism Spectrum Disorder (ASD), and to examine the association between TPS, executive functions and social functions. Design: This trial adopted a two-armed (verum TPS group vs. sham TPS group), double-blinded, randomized, sham-controlled design. Sampling: 32 subjects aged between 12 and 17, diagnosed with ASD were recruited. All subjects were computerized randomized into either verum TPS group or the sham TPS group on a 1:1 ratio. All subjects undertook functional MRI before and after the TPS interventions. Intervention: Six 30-min TPS sessions were administered to subjects in 2 weeks’ time on alternate days assessing neural connectivity changes. Baseline measurements and post-TPS evaluation of the ASD symptoms, executive functions, and social functions were conducted. Participants were followed up at 2-weeks, at 1-month and 3-month, assessing the short-and long-term sustainability of the TPS intervention. Data analysis: Generalized Estimating Equations with repeated measures were used to analyze the group and time difference. Missing data were managed by multiple imputations. The level of significance was set at p < 0.05. To our best knowledge, this is the first study evaluating the efficacy and safety of TPS among adolescents with ASD in Hong Kong and nationwide. Results emerging from this study will develop insight on whether TPS can be used as an adjunct treatment on ASD in neuroscience and clinical psychiatry. Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT05408793.

Keywords: adolescents, autism spectrum disorder, neuromodulation, rct, transcranial pulse stimulation

Procedia PDF Downloads 45

Authors: Leili Iranirad, Mohammad Saleh Sadeghi, Seyed Fakhreddin Hejazi, Negar Vakili Razlighi

Abstract:

Objective: Contrast-induced nephropathy (CIN) or contrast-induced acute kidney injury (CI-AKI) is an unknown acute kidney injury (AKI) occurring after exposure to contrast media (CM). Contrast agents are most often used for diagnostic procedures or therapeutic angiographic interventions. Recently, Na/K citrate as a urine alkalinization has been evaluated for the prevention of CIN. We conducted this experiment to evaluate the efficiency of Na/K citrate on CIN in high-risk patients treated with cardiac catheterization. Methods: A prospective randomized clinical trial was conducted on 400 patients having moderate to high-risk factors for CIN treated with elective percutaneous coronary intervention (PCI) and were assigned randomly to the control group or the Na/K citrate group. The Na/K citrate group (n=200) received 5 g Na/K citrate solution, which was diluted in 200 mL water two h before and four hours after the first administration and intravenous hydration for two h prior to and six h after the procedure, while the control group (n=200) only received intravenous hydration. Serum creatinine (SCr) was calculated prior to the contrast exposure and after 48 h. CIN was described as a 25% increase in creatinine of serum (SCr) or >0.5 mg/dl 48 h after contrast administration. Results: CIN was observed in 33 patients (16.5%) in the control group and in 6 patients (3%) in the Na/K citrate group. A significant variation was recorded in the CIN incidence between the two groups 48 h after the radiocontrast agent administration (p < 0.001). Conclusion: Our results show that Na/K citrate is useful and substantially reduces the incidence of CIN.

Keywords: contrast media, citrate, PCI

Procedia PDF Downloads 60

Authors: Moustafa Ibrahim Moustafa

Abstract:

The purpose of this study was to determine the immediate and long term effects of a multimodal program, with the addition of cervical sagittal curve restoration and forward head correction, on severity of dizziness, disability, frequency of dizziness, and severity of cervical pain. 72 patients with cervicogenic dizziness, definite hypolordotic cervical spine, and forward head posture were randomized to experimental or a control group. Both groups received the multimodal program, additionally, the study group received the Denneroll cervical traction. All outcome measures were measured at three intervals. The general linear model indicated a significant group × time effects in favor of experimental group on measures of anterior head translation (F=329.4 P < .0005), cervical lordosis (F=293.7 P < .0005), severity of dizziness (F=262.1 P < .0005), disability (F=248.9 P < .0005), frequency of dizziness (F=53.9 P < .0005), and severity of cervical pain (F=350.1 P < .0005). The addition of Dennroll cervical traction to a multimodal program can positively affect dizziness management outcomes.

Keywords: randomized controlled trial, traction, dizziness, cervical

Procedia PDF Downloads 279

Authors: Keng H. Kong, Louis C. Tan, Wing L. Aw, Kay Y. Tay

Abstract:

Background: Fatigue is a common problem in patients with Parkinson's disease, with reported prevalence of up to 70%. Fatigue can be disabling and has adverse effects on patients' quality of life. There is currently no satisfactory treatment of fatigue. Acupuncture is effective in the treatment of fatigue, especially that related to cancer. Its role in Parkinson's disease-related fatigue is uncertain. Aims: To evaluate the clinical efficacy of acupuncture treatment in Parkinson's disease-related fatigue. Hypothesis: We hypothesize that acupuncture is effective in alleviating Parkinson's disease-related fatigue. Design: A single center, randomized, controlled study with two parallel arms. Participants: Forty participants with idiopathic Parkinson's disease will be enrolled. Interventions: Participants will be randomized to receive verum (real) acupuncture or placebo acupuncture. The retractable non-invasive sham needle will be used in the placebo group. The intervention will be administered twice a week for five weeks. Main outcome measures: The primary outcome will be the change in general fatigue score of the multidimensional fatigue inventory at week 5. Secondary outcome measures include other subscales of the multidimensional fatigue inventory, movement disorders society-unified Parkinson's disease rating scale, Parkinson's disease questionnaire-39 and geriatric depression scale. All outcome measures will be assessed at baseline (week 0), completion of intervention (week 5) and 4 weeks after completion of intervention (week 9). Results: To date, 23 participants have been recruited and nine have completed the study. The mean age is 63.5±14.2 years, mean duration of Parkinson’s disease is 6.4±1.8 years and mean MDS-UPDRS score is 8.3±2.8. The mean general fatigue score of the multidimensional fatigue inventory is 13.5±4.6. No significant adverse event related to acupuncture is noted. Potential significance: If the results are as expected, this study will provide preliminary scientific evidence for the efficacy of acupuncture in Parkinson's Disease-related fatigue, and opens the door for a larger multicentre trial to be performed. In the longer term, it may lead to the integration of acupuncture in the care of patients with Parkinson's disease.

Keywords: acupuncture, fatigue, Parkinson's disease, trial

Procedia PDF Downloads 275

Authors: Andreas Aceranti, Stefano Costa

Abstract:

The aim of this study was to demonstrate that manipulative treatment combined with therapeutic exercisetherapywas more effective than isolated therapeutic exercise in the short-term treatment of eye convergence disorders in boxers. A randomized controlled trial (RCT) pilot trial was performed at our physiotherapy practices. 30 adult subjects who practice the discipline of boxing were selected after an initial skimming defined by the Convergence Insufficiency Symptom Survey (CISS) test (results greater than or equal to 10) starting from the initial sample of 50 subjects; The 30 recruits were evaluated by an orthoptist using prisms to know the diopters of each eye and were divided into 2 groups (experimental group and control group). The members of the experimental group were subjected to manipulation of the lateral strain of sphenoid from the side contralateral to the eye that had fewer diopters and were subjected to a sequence of 3 ocular motor exercises immediately after manipulation. The control group, on the other hand, received only ocular motor treatment. A secondary outcome was also drawn up that demonstrated how changes in ocular motricity also affected cervical rotation. Analysis of the data showed that the experimental treatment was in the short term superior to the control group to astatistically significant extent both in terms of the prismatic delta of the right eye (0 OT median without manipulation and 10 OT median with manipulation) and that of the left eye (0 OT median without manipulation and 5 OT median with manipulation). Cervical rotation values also showed better values in the experimental group with a median of 4° in the right rotation without manipulation and 6° with thrust; the left rotation presented a median of 2° without manipulation and 7° with thrust. From the results that emerged, the treatment was effective. It would be desirable to increase the sample number and set up a timeline to see if the net improvements obtained in the short term will also be maintained in the medium to long term.

Keywords: boxing, basilar spheno synchondrosis, ocular convergence deficit, osteopathic treatment

Procedia PDF Downloads 56

Authors: Nasrin Galehdar, Sedigheh Nadri, Elham Nazari, Isan Darvishi, Abouzar Mohammadi

Abstract:

Background and aim:Nausea and vomiting are complications of cesarean section. The pharmacological and non-pharmacological approaches were applied to decrease postoperative nausea and vomiting. The aim of the present study was to compare the effects of Ondansetron and acupressure on postoperative nausea and vomiting in patients undergone an elective cesarean section. Materials and method: The study was designed as a randomized clinical trial. A total of 120 patients were allocated to two equal groups. Four mgs of Ondansetron was administered for the Ondansetron group after clamping the umbilical cord. The acupressure bracelets were fastened in the PC6 point for acupressure group for 15 minutes. The patients were monitored in terms of incidence, severity, and episodes of nausea and vomiting. The data obtained were analyzed by SPSS software version 18 with a significance level of 0.05. Results: There was no significant statistical difference in nausea severity among the groups intra-operatively, in the recovery and surgery wards. The incidence and episodes of vomiting were significantly higher in patients undergone acupressure intra-operatively, in the recovery and surgery wards (P< 0.05). No significant effect of acupressure was reported in reducing postoperative nausea and vomiting. Conclusion: No significant effect of acupressure was reported in reducing postoperative nausea and vomiting. Thus, it is suggested to perform the studies with larger size and comparing the effects of acupressure with other antiemetic medications.

Keywords: ondansetron, acupressure, nausea, vomiting

Procedia PDF Downloads 82

Authors: James Jin, Weisi Xia, Runzhe Gao, Alain Vandal, Darren Svirkis, Andrew Hill

Abstract:

Background: Post-haemorrhoidectomy pain is concerned by patients/clinicians. Minimizing the postoperation pain is highly interested clinically. Combinations of topical cream targeting three hypothesised post-haemorrhoidectomy pain mechanisms were developed and their effectiveness were evaluated. Specifically, a multi-centred double-blinded randomized clinical trial (RCT) was conducted in adults undergoing excisional haemorrhoidectomy. The primary analysis was conveyed on the data collected to evaluate the effectiveness of the combinations of topical cream targeting three hypothesized pain mechanisms after the operations. Methods: 192 patients were randomly allocated to 4 arms (each arm has 48 patients), and each arm was provided with pain cream 10% metronidazole (M), M and 2% diltiazem (MD), M with 4% lidocaine (ML), or MDL, respectively. Patients were instructed to apply topical treatments three times a day for 7 days, and record outcomes for 14 days after the operations. The primary outcome was VAS pain on day 4. Covariates and models were selected in the blind review stage. Multiple imputations were applied for the missingness. LMER, GLMER models together with natural splines were applied. Sandwich estimators and Wald statistics were used. P-values < 0.05 were considered as significant. Conclusions: The addition of topical lidocaine or diltiazem to metronidazole does not add any benefit. ML had significantly better pain and recovery scores than combination MDL. Multimodal topical analgesia with ML after haemorrhoidectomy could be considered for further evaluation. Further trials considering only 3 arms (M, ML, MD) might be worth exploring.

Keywords: RCT, primary analysis, multiple imputation, pain scores, haemorrhoidectomy, analgesia, lmer

Procedia PDF Downloads 76

Authors: Maryam Shayani Rad, Seyed Ahmad Mohajeri, Mohsen Mouhebati, Seyed Danial Mousavi

Abstract:

High blood pressure is one of the most important and serious health-threatening because of no symptoms in most people, which can lead to sudden heart attack, heart failure, and stroke. Nowadays, herbal medicine is one of the best and safest strategies for treatment that have no adverse effects. Apium graveolens (celery) can be used as an alternative treatment for many health conditions such as hypertension. Natural compounds reduce blood pressure via different mechanisms in which Apium graveolens extract provides potent calcium channel blocking properties. A randomized, double-blind, placebo-controlled, cross-over clinical trial was done to evaluate the efficacy of formulated Apium graveolens extract with a maximum yield of 3-n-butylphthalide to reduce systolic and diastolic blood pressure in patients with hypertension. 54 hypertensive patients in the range of 20-68 years old were randomly assigned to the treatment group (26 cases) and the placebo control group (26 cases) and were crossed over after washout duration. The treatment group received at least 2 grams of formulated powder in hard capsules orally, before each meal, 2 times daily. The control group received 2 grams of placebo in hard capsules orally, exactly as the same as shape, time, and doses of treatment group. Treatment was administrated in 12 weeks with 4 weeks washout period at the middle of the study, meaning 4 weeks drug consumption for the treatment group, 4 weeks washout and 4 weeks placebo consumption, and vice versa for the placebo control group. The clinical assessment was done 4 times, including at the beginning and ending of the drug and placebo consumption period by 24-hour ambulatory blood pressure monitoring (ABPM) holter, which measured blood pressure every 15 minutes continuously. There was a statistically significant decrease in both systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the end of drug duration compared to baseline. The changes after 4 weeks on average was about 12.34 mm Hg for the SBP (P < 0.005) and 7.83 mm Hg for the DBP (P < 0.005). The results from this clinical trial study showed this Apium graveolens extract formulation in the mentioned dosage had a significant effect on blood pressure-lowering for hypertensive patients.

Keywords: Apium graveolens extract, clinical trial, cross-over, hypertension

Procedia PDF Downloads 180

Authors: Fasanmi Samuel Sunday

Abstract:

This study investigated the influence of gender and personality traits on emotional distress among awaiting trial inmates in Nigeria. Participants were three hundred and twenty (320) awaiting trial inmates, drawn from three main correctional centres in Northeast Nigeria, namely: Gashua Correctional Centre, Postiskum Correctional Centre, and Bauchi Correctional Centre. Expo facto research design was adopted. Questionnaires such as the Big Five Inventory and the Perceived Emotional Distress Inventory (PEDI) were used to measure the variables of the study. Three hypotheses were tested. Logistic regression was used for data analysis. Results of the analysis indicated that conscientiousness significantly predicted emotional distress among awaiting trial inmates. However, most of the identified personality traits did not significantly predict emotional distress among awaiting trial inmates. There was no significant gender difference in emotional distress among awaiting-trial inmates. The implications of the study were discussed.

Keywords: personality traits, emotional distress, awaiting-trial inmates, gender

Procedia PDF Downloads 69

Authors: Foong Kiew Ooi, Aidi Naim Mohamad Samsani, Chee Keong Chen, Mohamed Saat Ismail

Abstract:

Introduction: Prolonged exercise in a hot and humid environment can result in glycogen depletion and associated with loss of body fluid. Carbohydrate contained in sports beverages is beneficial for improving sports performance and preventing dehydration. Carbohydrate contained in honey is believed can be served as an alternative form of carbohydrate for enhancing sports performance. Objective: To investigate the effectiveness of honey drink compared to sports drink as a recovery aid for running performance and physiological parameters in the heat. Method: Ten male recreational athletes (age: 22.2 ± 2.0 years, VO2max: 51.5 ± 3.7 ml.kg-1.min-1) participated in this randomized cross-over study. On each trial, participants were required to run for 1 hour in the glycogen depletion phase (Run-1), followed by a rehydration phase for 2 hours and subsequently a 20 minutes time trial performance (Run-2). During Run-1, subjects were required to run on the treadmill in the heat (31°C) with 70% relative humidity at 70 % of their VO2max. During rehydration phase, participants drank either honey drink or sports drink, or plain water with amount equivalent to 150% of body weight loss in dispersed interval (60 %, 50 % and 40 %) at 0 min, 30 min and 60 min respectively. Subsequently, time trial was performed by the participants in 20 minutes and the longest distance covered was recorded. Physiological parameters were analysed using two-way ANOVA with repeated measure and time trial performance was analysed using one-way ANOVA. Results: Result showed that Acacia honey elicited a better time trial performance with significantly longer distance compared to water trial (P<0.05). However, there was no significant difference between Acacia honey and sport drink trials (P > 0.05). Acacia honey and sports drink trials elicited 249 m (8.24 %) and 211 m (6.79 %) longer in distance compared to the water trial respectively. For physiological parameters, plasma glucose, plasma insulin and plasma free fatty acids in Acacia honey and sports drink trials were significantly higher compared to the water trial respectively during rehydration phase and time trial running performance phase. There were no significant differences in body weight changes, oxygen uptake, hematocrit, plasma volume changes and plasma cortisol in all the trials. Conclusion: Acacia honey elicited greatest beneficial effects on sports performance among the drinks, thus it has potential to be used for rehydration in athletes who train and compete in hot environment.

Keywords: honey drink, rehydration, sports performance, plasma glucose, plasma insulin, plasma cortisol

Procedia PDF Downloads 281

Authors: Moses Mwangi, Geert Verbeke, Geert Molenberghs

Abstract:

Cross-over designs are commonly used in randomized clinical trials to estimate efficacy of a new treatment with respect to a reference treatment (placebo or standard). The main advantage of using cross-over design over conventional parallel design is its flexibility, where every subject become its own control, thereby reducing confounding effect. Jones & Kenward, discuss in detail more recent developments in the analysis of cross-over trials. We revisit the simple piecewise linear mixed-effects model, proposed by Mwangi et. al, (in press) for its first application in the analysis of cross-over trials. We compared performance of the proposed piecewise linear mixed-effects model with two commonly cited statistical models namely, (1) Grizzle model; and (2) Jones & Kenward model, used in estimation of the treatment effect, in the analysis of randomized cross-over trial. We estimate two performance measurements (mean square error (MSE) and coverage probability) for the three methods, using data simulated from the proposed piecewise linear mixed-effects model. Piecewise linear mixed-effects model yielded lowest MSE estimates compared to Grizzle and Jones & Kenward models for both small (Nobs=20) and large (Nobs=600) sample sizes. It’s coverage probability were highest compared to Grizzle and Jones & Kenward models for both small and large sample sizes. A piecewise linear mixed-effects model is a better estimator of treatment effect than its two competing estimators (Grizzle and Jones & Kenward models) in the analysis of cross-over trials. The data generating mechanism used in this paper captures two time periods for a simple 2-Treatments x 2-Periods cross-over design. Its application is extendible to more complex cross-over designs with multiple treatments and periods. In addition, it is important to note that, even for single response models, adding more random effects increases the complexity of the model and thus may be difficult or impossible to fit in some cases.

Keywords: Evaluation, Grizzle model, Jones & Kenward model, Performance measures, Simulation

Procedia PDF Downloads 94

Authors: Muhammad Fatahillah Akbar

Abstract:

Criminal Procedural Law is established to protect the society from the abuse of authority. To achieve that purpose, the criminal procedural law shall be established in accordance with the laws of human right and the protection of the society. One of the mechanisms to protect human rights and to ensure the compliance of authorities in criminal procedural law is pre-trial mechanism. In many countries, there are various mechanisms of pre-trial. In the recent cases in Indonesia, pre-trial has been an interesting issue. The issue is also addressed by the Constitutional Court Decision Number 21/PUU-XII/2014 which enhance the competence of pre-trial which includes the suspect determination and the legality of seizure and search. Before that decision, some pre-trial decisions have made landmark decision by enhancing the competence of pre-trial, such as the suspect determination case in Budi Gunawan Case and legality of the investigation in Hadi Purnomo Case. These pre-trial cases occurred because the society needs protection even though it is not provided by written legislations, in this matter, The Indonesian Criminal Procedural Code (KUHAP). For instance, a person can be a suspect for unlimited time because the Criminal Procedural Code does not regulate the limit of investigation, so the suspect enactment shall be able to be challenged to protect human rights. Before the Constitutional Court Decision Suspect Determination cannot be challenged so that the society is not fully protected. The Constitutional Court Decision has provided more protections. Nowadays, investigators shall be more careful in conducting the investigation. However, those decisions, including the Constitutional Court Decision are not sufficient for society to be protected by abuse of authority. For example, on 7 March 2017, a single judge, in a Pre-Trial, at the Surabaya District Court, decided that the investigation was unlawful and shall be terminated. This is not regulated according to the Code and also any decisions in pre-trial. It can be seen that the reform of pre-trial is necessary. Hence, this paper aims to examine how pre-trial shall be developed in the future to provide wide access for society to have social justice in criminal justice system. The question will be answered by normative, historical, and comparative approaches. Firstly, the paper will examine the history of pre-trial in Indonesia and also landmark decisions on pre-trial. Then, the lessons learned from other countries regarding to the pre-trial mechanism will be elaborated to show how pre-trial shall be developed and what the competences of a pre-trial are. The focus of all discussions shall be on how the society is protected and provided access to legally complain to the authority. At the end of the paper, the recommendation to reform the pre-trial mechanism will be suggested.

Keywords: pre-trial, criminal procedural law, society

Procedia PDF Downloads 137

Authors: Nuraisyah H. Zulkifley, Suriani Ismail, Rosliza Abdul Manaf, Poh Y. Lim

Abstract:

Taking care of a person with dementia (PWD) is one of the most problematic and challenging caregiving situations. Without proper support, caregiver would need to deal with the impact of caregiving that would lead to caregiver burden. One of the most common tools used to measure caregiver burden among caregivers of PWD is Zarit Burden Interview (ZBI). A systematic review has been conducted through searching Medline, Science Direct, Cochrane Library, Embase, PsycINFO, ProQuest, and Scopus databases to identify relevant articles that elaborate on intervention and outcomes on ZBI among informal caregiver of PWD. The articles were searched in October 2019 with no restriction on language or publication status. Inclusion criteria are randomized control trial (RCT) studies, participants were informal caregivers of PWD, ZBI measured as outcomes, and intervention group was compared with no intervention control or usual care control. Two authors reviewed and extracted the data from the full-text articles. From a total of 344 records, nine studies were selected and included in this narrative review, and eight studies were included in the meta-analysis. The types of interventions that were implemented to ease caregiver burden are psychoeducation, physical activity, psychosocial, and computer-based intervention. The meta-analysis showed that there is a significant difference in the mean score of ZBI (p = 0.006) in the intervention group compared to the control group after implementation of intervention. In conclusion, interventions such as psychoeducation, psychosocial, and physical activity can help to reduce the burden experiencing by the caregivers of PWD.

Keywords: dementia, informal caregiver, randomized control trial, Zarit burden interview

Procedia PDF Downloads 155

Authors: Brian Moore, Stuart Woodcock, Dean Dudley

Abstract:

Mental health problems have significant social and economic consequences; however, many individuals do not seek traditional assistance for mental health difficulties. Martial arts training may provide an inexpensive alternative to traditional psychological therapy. While limited research has suggested martial arts training may be an efficacious intervention, the validity and reliability of this are questionable given the small number of relevant studies and other methodological problems. The study examined the effects of 10-week martial arts-based psycho-social intervention which was evaluated using a randomized controlled trial. The intervention was delivered to 283 secondary school students, aged between 12-14 years, who were recruited from government and catholic secondary schools in New South Wales, Australia. The intervention was delivered in a group format onsite at participating schools and had an intervention dose of 10 x 50-60 minute sessions, once per week for 10 weeks. Data were collected at baseline, post-intervention, and 12-week follow-up. Results found a consistent pattern for strength based wellbeing outcomes. All primary and secondary measures relating to resilience and self-efficacy improved for the intervention group and declined for the control group. As these findings were derived from a robust design and rigorous evaluation, they provide valid and reliable evidence that martial arts-based psycho-social interventions can be considered as an efficacious method of improving strength and wellbeing outcomes.

Keywords: martial arts, mental health, resilience, self-efficacy

Procedia PDF Downloads 131

Authors: Zia Ul Haq, Saleem Muhammad, Naeem Ullah, Abbas Shah, Abdullah Shah

Abstract:

Pakistan being the developing country is facing double burden of communicable and non-communicable disease. The aspect of secondary prevention of ischemic heart disease in developing countries is the dire need for public health specialists, clinicians and policy makers. There is some evidence that psychotherapeutic measures, including psychotherapy, recreation, exercise and stress management training have positive impact on secondary prevention of cardiovascular diseases but there are some contradictory findings as well. Cardiac rehabilitation program (CRP) has not yet fully implemented in Pakistan. Psychological, physical and specific health-related quality of life (HRQoL) outcomes needs assessment with respect to its practicality, effectiveness, and success. Objectives: To determine the effect of cardiac rehabilitation program (CRP) on the health-related quality of life (HRQoL) measures of post MI patients compared to the usual care. Hypothesis: Post MI patients who receive the interventions (CRP) will have better HRQoL as compared to those who receive the usual cares. Methods: The randomized control trial was conducted at a Cardiac Rehabilitation Unit of Lady Reading Hospital (LRH), Peshawar. LRH is the biggest hospital of the Province Khyber Pakhtunkhwa (KP). A total 206 participants who had recent first myocardial infarction were inducted in the study. Participants were randomly allocated into two group i.e. usual care group (UCG) and cardiac rehabilitation group (CRG) by permuted-block randomization (PBR) method. CRP was conducted in CRG in two phases. Three HRQoL outcomes i.e. general health questionnaire (GHQ), self-rated health (SRH) and MacNew quality of life after myocardial infarction (MacNew QLMI) were assessed at baseline and follow-up visits among both groups. Data were entered and analyzed by appropriate statistical test in STATA version 12. Results: A total of 195 participants were assessed at the follow-up period due to lost-to-follow-up. The mean age of the participants was 53.66 + 8.3 years. Males were dominant in both groups i.e. 150 (76.92%). Regarding educational status, majority of the participants were illiterate in both groups i.e. 128 (65.64%). Surprisingly, there were 139 (71.28%) who were non-smoker on the whole. The comorbid status was positive in 120 (61.54%) among all the patients. The SRH at follow-up among UCG and CRG was 4.06 (95% CI: 3.93, 4.19) and 2.36 (95% CI: 2.2, 2.52) respectively (p<0.001). GHQ at the follow-up of UCG and CRG was 20.91 (95% CI: 18.83, 21.97) and 7.43 (95% CI: 6.59, 8.27) respectively (p<0.001). The MacNew QLMI at follow-up of UCG and CRG was 3.82 (95% CI: 3.7, 3.94) and 5.62 (95% CI: 5.5, 5.74) respectively (p<0.001). All the HRQoL measures showed strongly significant improvement in the CRG at follow-up period. Conclusion: HRQOL improved in post MI patients after comprehensive CRP. Education of the patients and their supervision is needed when they are involved in their rehabilitation activities. It is concluded that establishing CRP in cardiac units, recruiting post-discharged MI patients and offering them CRP does not impose high costs and can result in significant improvement in HRQoL measures. Trial registration no: ACTRN12617000832370

Keywords: cardiovascular diseases, cardiac rehabilitation, health-related quality of life, HRQoL, myocardial infarction, quality of life, QoL, rehabilitation, randomized control trial

Procedia PDF Downloads 197

Authors: Matthew Cameron, Stephen Yang, Latifa Al Kharusi, Adam Gosselin, Anissa Chirico, Pouya Gholipour Baradari

Abstract:

Background: Iron supplementation has been evaluated in several randomized controlled trials (RCTs) for the potential to increase baseline hemoglobin and decrease the incidence of red blood cell (RBC) transfusion during cardiac surgery. This study's main objective was to evaluate the evidence for iron administration in cardiac surgery patients for its effect on the incidence of perioperative RBC transfusion. Methods: This systematic review protocol was registered with PROSPERO (CRD42020161927) on Dec. 19th, 2019, and was prepared as per the PRISMA guidelines. MEDLINE, EMBASE, CENTRAL, Web of Science databases, and Google Scholar were searched for RCTs evaluating perioperative iron administration in adult patients undergoing cardiac surgery. Each abstract was independently reviewed by two reviewers using predefined eligibility criteria. The primary outcome was perioperative RBC transfusion, with secondary outcomes of the number of RBC units transfused, change in ferritin level, reticulocyte count, hemoglobin, and adverse events, after iron administration. The risk of bias was assessed with the Cochrane Collaboration Risk of Bias Tool, and the primary and secondary outcomes were analyzed with a random-effects model. Results: Out of 1556 citations reviewed, five studies (n = 554 patients) met the inclusion criteria. The use of iron demonstrated no difference in transfusion incidence (RR 0.86; 95% CI 0.65 to 1.13). There was a low heterogeneity between studies (I²=0%). The trial sequential analysis suggested an optimal information size of 1132 participants, which the accrued information size did not reach. Conclusion: The current literature does not support the routine use of iron supplementation before cardiac surgery; however, insufficient data is available to draw a definite conclusion. A critical knowledge gap has been identified, and more robust RCTs are required on this topic.

Keywords: cardiac surgery, iron, iron supplementation, perioperative medicine, meta-analysis, systematic review, randomized controlled trial

Procedia PDF Downloads 106

Authors: Meryem Aydin, Serdar Karadas, Ercan Ceyhan

Abstract:

The research was conducted to determine effects of salt concentrations on emergence of cowpea genotypes. Trials were performed during the year of 2014 on the laboratory of Agricultural Faculty, Selcuk University. Emergency trial was set up according to “Randomized Plots Design” by two factors and four replications with three replications. Samandag, Akkiz-86, Karnikara and Sarigobek cowpea genotypes have been used as trial material in this study. Effects of the five doses of salt concentrations (control, 30 mM, 60 mM, 90 mM and 120 mM) on the ratio of emergency, speed of emergency, average time for emergency, index of sensibility were evaluated. Responses of the cowpea genotypes for salt concentrations were found different. Comparing to the control, all of the investigated characteristics on the cowpea genotypes showed significant reduction by depending on the increasing salt application. According to the effects of salt application, the cowpea genotypes Samandag and Karnikara were the most tolerant in respect to index of sensibility while the Sarigobek genotypes was the most sensitive.

Keywords: cowpea, Vigna sinensis, emergence, salt tolerant

Procedia PDF Downloads 231

Authors: Carla Nardelli, Jérome Holtzmann, Céline Baeyens, Catherine Bortolon

Abstract:

Background. Emotion regulation (ER) is a process associated with difficulties in mental health. Given its transdiagnostic features, its improvement could facilitate the recovery of various psychological issues. A limit of current studies is the lack of knowledge regarding whether available interventionsimprove ER flexibility (i.e., the ability to implement ER strategies in line with contextual demands), even though this capacity has been associated with better mental health and well-being. Therefore, the aim of the study is to test the efficacy of a 9-weeks ER group program (the Affect Regulation Training-ART), using the most appropriate measures (i.e., experience sampling method) in a student population. Plus, the goal of the study is to explore the potential mediative role of ER flexibility on mental health improvement. Method. This Randomized Controlled Trial will comparethe ER program group to an active control group (a relaxation program) in 100 participants. To test the mediative role of ER flexibility on mental health, daily measures will be used before, during, and after the interventions to evaluate the extent to which participants are flexible in their ER. Expected outcomes. Using multilevel analyses, we expect an improvement in anxious-depressive symptomatology for both groups. However, we expect the ART group to improve specifically on ER flexibility ability and the last to be a mediative variable on mental health. Conclusion. This study will enhance knowledge on interventions for students and the impact of interventions on ER flexibility. Also, this research will improve knowledge on ecological measures for assessing the effect of interventions. Overall, this project represents new opportunities to improve ER skills to improve mental health in undergraduate students.

Keywords: emotion regulation flexibility, experience sampling method, psychological intervention, emotion regulation skills

Procedia PDF Downloads 109

Authors: D. Farsi, G. Dokhtvasi, S. Abbasi, S. Shafiee Ardestani, E. Payani

Abstract:

Background and aim:It has not been well studied whether fentanyl-thiopental (FT) is effective and safe for PSA in orthopedic procedures in Emergency Department (ED). The aim of this trial was to evaluate the effectiveness of intravenous FTversusfentanyl-midazolam (FM)in patients who suffered from shoulder dislocation or distal radial fracture-dislocation. Methods:In this randomized double-blinded study, Seventy-six eligible patients were entered the study and randomly received intravenous FT or FM. The success rate, onset of action and recovery time, pain score, physicians’ satisfaction and adverse events were assessed and recorded by treating emergency physicians. The statistical analysis was intention to treat. Results: The success rate after administrating loading dose in FT group was significantly higher than FM group (71.7% vs. 48.9%, p=0.04); however, the ultimate unsuccess rate after 3 doses of drugs in the FT group was higher than the FM group (3 to 1) but it did not reach to significant level (p=0.61). Despite near equal onset of action time in two study group (P=0.464), the recovery period in patients receiving FT was markedly shorter than FM group (P<0.001). The occurrence of adverse effects was low in both groups (p=0.31). Conclusion: PSA using FT is effective and appears to be safe for orthopedic procedures in the ED. Therefore, regarding the prompt onset of action, short recovery period of thiopental, it seems that this combination can be considered more for performing PSA in orthopedic procedures in ED.

Keywords: procedural sedation and analgesia, thiopental, fentanyl, midazolam, orthopedic procedure, emergency department, pain

Procedia PDF Downloads 233

Authors: Teagan Fink, Lynn Chong, Michael Hii, Brett Knowles

Abstract:

Background: Telemedicine is a rapidly advancing field providing healthcare to patients at a distance from their treating clinician. There is a paucity of high-quality evidence detailing the safety and acceptability of telemedicine for postoperative outpatient follow-up. This randomized controlled trial – conducted prior to the COVID 19 pandemic – aimed to assess patient satisfaction and safety (as determined by readmission, reoperation and complication rates) of telephone compared to face-to-face clinic follow-up after uncomplicated general surgical procedures. Methods: Patients following uncomplicated laparoscopic appendicectomy or cholecystectomy and laparoscopic or open umbilical or inguinal hernia repairs were randomized to a telephone or face-to-face outpatient clinic follow-up. Data points including patient demographics, perioperative details and postoperative outcomes (eg. wound healing complications, pain scores, unplanned readmission to hospital and return to daily activities) were compared between groups. Patients also completed a Likert patient satisfaction survey following their consultation. Results: 103 patients were recruited over a 12-month period (21 laparoscopic appendicectomies, 65 laparoscopic cholecystectomies, nine open umbilical hernia repairs, six laparoscopic inguinal hernia repairs and two laparoscopic umbilical hernia repairs). Baseline patient demographics and operative interventions were the same in both groups. Patient or clinician-reported concerns on postoperative pain, use of analgesia, wound healing complications and return to daily activities at clinic follow-up were not significantly different between the two groups. Of the 58 patients randomized to the telemedicine arm, 40% reported high and 60% reported very high patient satisfaction. Telemedicine clinic mean consultation times were significantly shorter than face-to-face consultation times (telemedicine 10.3 +/- 7.2 minutes, face-to-face 19.2 +/- 23.8 minutes, p-value = 0.014). Rates of failing to attend clinic were not significantly different (telemedicine 3%, control 6%). There was no increased rate of postoperative complications in patients followed up by telemedicine compared to in-person. There were no unplanned readmissions, return to theatre, or mortalities in this study. Conclusion: Telemedicine follow-up of patients undergoing uncomplicated general surgery is safe and does not result in any missed diagnosis or higher rates of complications. Telemedicine provides high patient satisfaction and steps to implement this modality in inpatient care should be undertaken.

Keywords: general surgery, telemedicine, patient satisfaction, patient safety

Procedia PDF Downloads 95

Authors: Mostafa Solati

Abstract:

Objectives: Considering the gap of information regarding the optimal antimicrobial efficacy of metronidazole for application in the implant screw hole, this study aimed to compare the antimicrobial efficacy of 0.75% metronidazole and 2% chlorhexidine (CHX) gel applied in the implant screw hole. Materials and Methods: This randomized controlled clinical trial evaluated 60 implants (20 patients, each requiring three implants) in three groups (n=20). In group 1, 0.75% metronidazole gel was applied to the implant screw hole. In group 2, 2% CHX gel was applied, and in group 3, no material was used. Microbial samples were collected from the screw holes after three months, and the microbial colonies were counted. Data were analyzed using ANOVA. Results: The number of bacteria in the control group was significantly higher than that in 0.75% metronidazole gel and 2% CHX groups (P<0.05). The CHX group caused the maximum reduction in colony count with no significant difference from the metronidazole group (P>0.05). Conclusion: The application of 0.75% metronidazole gel and 2% CHX can effectively decrease the colony count in the implant screw hole and can probably play a role in the preservation of peri-implant tissue health.

Keywords: dental implant, metronidazole, CHX, screw hole

Procedia PDF Downloads 45

Authors: Ghada M. R. Koura, Mohamed N. Mohamed, Ahmed M. F. El Shiwi

Abstract:

Chronic mechanical Low back dysfunction (CMLBD) is the most common problem of the working-age population in modern industrial sociaty; it causes a substantial economic burden due to the wide use of medical services and absence from work. Aim of work: the aim of this study was to investigate the effect of positional release technique on patients with chronic mechanical low back pain. Materials and Methods: Thirty two patients from both sexes were diagnosed with CMLBP, aged 20 to 45 years and were divided randomly into two equal groups; sixteen patients each; group A (control group) received therapeutic exercises that include (Stretch and Strength exercises for back and abdominal muscles). Group B (experimental group) received therapeutic exercises with positional release technique; treatment was applied 3 days/week for 4 weeks. Pain was measured by Visual Analogue Scale, Lumbar range of motion was measured by Inclinometer and Functional disability was measured by Oswestry disability scale. Measurements were taken at two intervals pre-treatment and post-treatment. Results: Data obtained was analyzed via paired and unpaired t-Test. There were statistical differences between the 2 groups, where the experimental group showed greater improvement than control group. Conclusion: Positional release technique is considered as an effective treatment for reducing pain, functional disability and increasing lumbar range of motion in individuals with chronic mechanical low back pain.

Keywords: chronic mechanical low back pain, traditional physical therapy program, positional release technique, randomized controlled trial

Procedia PDF Downloads 567

Authors: Mahboobeh Sadeghi, Zahra Izadi Khah, Mansour Hakim Javadi, Masoud Gholamali Lavasani

Abstract:

Background: Since there is a relation between psychological and physiological factors, the aim of this study was to examine the effect of Emotion Regulation training on cognitive emotion regulation problem in patients with Multiple Sclerosis(MS) Method: In a randomized clinical trial thirty patients diagnosed with Multiple Sclerosis referred to state welfare organization were selected. The sample group was randomized into either an experimental group or a nonintervention control group. The subjects participated in 75-minute treatment sessions held three times a week for 4weeks (12 sessions). All 30 individuals were administered with Cognitive Emotion Regulation questionnaire (CERQ). Participants completed the questionnaire in pretest and post-test. Data obtained from the questionnaire was analyzed using Mancova. Results: Emotion Regulation significantly decreased the Cognitive Emotion Regulation problems patients with Multiple sclerosis (p < 0.001). Conclusions: Emotion Regulation can be used for the treatment of cognitive-emotion regulation problem in Multiple sclerosis.

Keywords: Multiple Sclerosis, cognitive-emotion regulation, emotion regulation, MS

Procedia PDF Downloads 429

Authors: Ying-Yi Laio, Yea-Ru Yang, Yih-Ru Wu, Ray-Yau Wang

Abstract:

Background: Virtual reality (VR) systems are proved to increase motor performance in stroke and elderly. However, the effects have not been established in patients with Parkinson’s disease (PD). Purpose: To examine the effects of VR based training in improving muscle strength, sensory integration ability and walking abilities in patients with PD by a randomized controlled trial. Method: Thirty six participants with diagnosis of PD were randomly assigned to one of the three groups (n=12 for each group). Participants received VR-based Wii Fit exercise (VRWii group) or traditional exercise (TE group) for 45 minutes, followed by treadmill training for another 15 minutes for 12 sessions in 6 weeks. Participants in the control group received no structured exercise program but fall-prevention education. Outcomes included lower extremity muscle strength, sensory integration ability, walking velocity, stride length, and functional gait assessment (FGA). All outcomes were assessed at baseline, after training and at 1-month follow-up. Results: Both VRWii and TE groups showed more improvement in level walking velocity, stride length, FGA, muscle strength and vestibular system integration than control group after training and at 1-month follow-up. The VRWii training, but not the TE training, resulted in more improvement in visual system integration than the control. Conclusions: VRWii training is as beneficial as traditional exercise in improving walking abilities, sensory integration ability and muscle strength in patients with PD, and such improvements persisted at least for 1 month. The VRWii training is then suggested to be implemented in patients with PD.

Keywords: virtual reality, walking, sensory integration, muscle strength, Parkinson’s disease

Procedia PDF Downloads 306

Authors: Muhammad Tanziel Aziezi

Abstract:

In Indonesia, pre-trial (in Indonesia called ‘praperadilan’) is a mechanism that is regulated on Criminal Procedure Code as a form of oversight and check and balance on the process at the stage of inquiry, investigation, and prosecution, so that actions taken by the State (in this case, the police and prosecutor) is carried out in accordance with its authority and not violate human rights. Article 77 of the Criminal Procedure Code has been set that the object may be filed pretrial is just about the lawfulness of the arrest, the lawfulness of the detention, and the legitimacy of stopping investigation and prosecution. However, since the beginning of 2015, there was a further object which is then entered as a pre-trial object, namely the lawfulness of the determination of a criminal suspect. This is because the determination of the suspect is considered as one of the forceful measures that could restrict the rights of a person, so the implementation should have oversight and checks and balances by the courts. This paper will discuss the development of the pre-trial on the lawfulness of the determination of a criminal suspect as a new judicial mechanism as the protection of human rights in Indonesia.

Keywords: criminal procedure law, pre-trial, lawfulness of determination of a criminal suspect, check and balance by the court

Procedia PDF Downloads 310

Authors: Pitchaporn Purngpiputtrakul, Suttasinee Petsakul, Sunisa Chatmongkolchart

Abstract:

Nasogastric tube (NGT) insertion in anaesthetized and intubated patients can be challenging even for experienced anesthesiologists. Various techniques have been proposed to facilitate NGT insertion in these patients. This study aimed to compare the success rate and time required for NGT insertion between the GlideScope visualization and neck flexion with lateral neck pressure techniques. This randomized clinical trial was performed at a teaching hospital on 86 adult patients undergoing abdominal surgery under relaxant general anaesthesia who required intraoperative NGT insertion. The patients were randomized into two groups, the GlideScope group (group G) and the neck flexion with lateral neck pressure group (group F). The success rate of first and second attempts, duration of insertion, and complications were recorded. The total success rate was 79.1% in Group G compared with 76.7% in Group F (P=1) The median time required for NGT insertion was significantly longer in Group G, for both first and second attempts (97 vs 42 seconds P<0.001) and (70 vs 48.5 seconds P=0.015), respectively. Complications were reported in 23 patients (53.5%) in group G and 13 patients (30.2%) in group F. Bleeding and kinking were the most common complications in both techniques. Using GlideScope visualization to facilitate NGT insertion was comparable to neck flexion with lateral neck pressure technique in degree of success rate of insertion, while neck flexion with lateral neck pressure technique had fewer complications and was less time-consuming.

Keywords: anaesthesia, nasogastric tube, GlideScope, intubation

Procedia PDF Downloads 134

Authors: Nalanda Roy

Abstract:

The project will offer a fresh and critical perspective into the Tokyo Trial judgment led by the Indian Jurist Dr. Radha Binod Pal. The project will focus on the Third World Approach to International Law (TWAIL) methodology to examine the relevance of international law from the post-colonial perspectives. The project will analyze Pal’s dissenting arguments from a new and comparative perspective, apply for work from other disciplines, and create an understanding of the significance of the historic judgment considering its contemporary relevance, and fill in the gaps that exist in the call for global justice.

Keywords: Tokyo trial, third world, judgment, international law

Procedia PDF Downloads 61

Authors: Erinda Male

Abstract:

Participation of a lawyer in any criminal proceedings on behalf of an accused person or a victim is essential to a fair trial. Legal representation is particularly crucial in proceedings before international tribunals, especially in the International Criminal Court. The paper thus focuses on the importance of the legal representation of victims and defendants before the ICC, as well as on the role of the legal representative in the proceedings before the court and the principle of freedom of choice of legal representatives. Also, the paper presents a short overview of the significance of legal representatives for victims and the necessity to protect their primary role in the ICC system, and ensure that it is coherent and respectful of victims’ rights. Victim participation is an important part of the ICC Statute and it is designed to help ensure that those most affected by the crimes are able to engage with the Court. Proper and quality legal representation ensures meaningful participation of victims at stages of the proceedings before ICC. Finally, the paper acknowledges the role of legal representatives during the pre-trial, trial and post-trial phase, the different modalities in selecting the legal representatives as well as balancing victims’ participation with the right of the accused to a fair trial.

Keywords: fair trial, freedom of choice principle, international criminal court, legal representatives, victims

Procedia PDF Downloads 363

Authors: Navid P Roodaki, Rochelle Abila, Daisy Evangeline Garcia

Abstract:

Background and Objective: Respiratory Distress Syndrome (RDS) among premature infants is a major causes of neonatal death. The use of Continuous Positive Airway Pressure (CPAP) has become a standard of care for preterm newborns with RDS hence cost-effective innovations are needed. This study compared a novel low-cost Bubble CPAP (bCPAP) device to ventilator driven CPAP in the treatment of RDS. Methods: This is a single-blind, randomized controlled trial done on May 2022 to October 2022 in a Level III Neonatal Intensive Care Unit in the Philippines. Preterm newborns (<36 weeks) with RDS were randomized to receive Vayu bCPAP device or Ventilator-derived CPAP. Arterial Blood Gases, Oxygen Saturation, administration of surfactant, and CPAP failure rates were measured. Results: Seventy preterm newborns were included. No differences were observed between the Ventilator driven CPAP and Vayu bCPAP on the PaO2 (97.51mmHg vs 97.37mmHg), So2 (97.08% vs 95.60%) levels, amount of surfactant administered between groups. There were no observed differences in CPAP failure rates between Vayu bPCAP (x̄ 3.23 days) and ventilator-driven CPAP (x̄ 2.98 days). However, a significant difference was noted on the CO2 level (40.32mmHg vs 50.70mmHg), which was higher among those hooked to Ventilator-driven CPAP (p 0.004). Conclusion: This study has shown that the novel low-cost bubble CPAP (Vayu bCPAP) can be used as an efficacious alternate non invasive oxygen therapy among preterm neonates with RDS, although the CO2 levels were higher among those hooked to ventilator driven CPAP, other outcome parameters measured showed that both devices are comparable. Recommendation: A multi-center or national study to account for geographic region, which may alter the outcomes of patients connected to different ventilatory support. Cost comparison between devices is also suggested. A mixed-method research assessing the experiences of health care professionals in assembling and utilizing the gadget is a second consideration.

Keywords: bubble CPAP, ventilator-derived CPAP; infant, premature, respiratory distress syndrome

Procedia PDF Downloads 48