Search results for: randomized controlled trial

Authors: Ali Faisal Saleem, Farheen Quadri, Mach Ondrej, Anita Zaidi

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Purpose: Pakistan is the final frontier for a polio-free world. Chronic malnutrition is associated with lack of effective gut immunity, and possibly associated with poliomyelitis in children received multiple OPV. We evaluate IPV dose administered together with OPV results in higher immunogenicity and mucosal immunity compared to OPV alone in chronically malnourished infants. Methods AND Materials: A community-based, unblinded-randomized-trial, conducted in 5 peri-urban, low-middle-income households of Karachi, in infants 9-12 months. Two study groups were non-malnourished (HAZ= -2 or more) and chronic malnourished (HAZ <-2SD), with 2-arms each i) OPV and ii) OPV and IPV. Two blood specimens (2ml) at baseline and at day 28 and two stool specimens (6 gm.) at day 29 and after 7 days. All infants received a bOPV challenge dose after first stool specimen. Calculates sample size was 210 in each arm. Serological (baseline compared to 28 days post-vaccine) and mucosal immunity after one week of bOPV challenge dose were study outcomes. Results: Baseline seroprevalence in malnourished infants were low compared to non-malnourished (P1, P2 and P3 (p=<0.001). There is significant rise in antibody titer and P1 seroprevalence in Mal A and B after receiving study vaccine; much higher in Mal B. Infants randomized to bOPV + IPV study vaccine showed incremental immune response against P1 (Mal B, 92.2%; Nor B, 98.4%), P2 (Mal B, 90.4%; Nor B, 94.7%), and P3 (Mal B, 85.6% and Nor B, 93.5%) was observed. A significant proportion of infants in malnourished (P1, 13%; P2, 24%; P3, 26%) and normally nourished group (P1, 5%; P2, 11%; P3, 14%) were found to be seronegative at baseline. Infants who received BOPV + IPV as their study vaccine showed a very high seroconversion response after vaccine (p=<0.001 for P1, P2 and P3). Majority of the specimens were negative at baseline (Mal A, 2%, Mal B, 1%; Nor A, 2%; Nor B, 1%), and remains negative after bOPV challenge dose (Mal A, 8%, Mal B, 6%; Nor A, 11%; Nor B, 10%). Conclusion: Malnourished-infants have low poliovirus-seroprevalence that increased remarkably after IPV. There is less viral shedding after IPV in infants.

Keywords: chronic malnutrition, infants, IPV, OPV

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Authors: Denis Duagi, Ben Carter, Maria Farrelly, Stephen Lisk, June S. L. Brown

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Background: Adolescence represents a distinctive phase of development, and variables linked to this developmental period could affect the efficiency of prevention and treatment for depression and anxiety, as well as the long-term prognosis. The objectives of this study were to investigate the long-term effectiveness of psychosocial interventions for adolescents on depression and anxiety symptoms and to assess the influence of different intervention parameters on the long-term effects. Methods: Searches were carried out on the 11ᵗʰ of August 2022 using five databases (Cochrane Library, Embase, Medline, PsychInfo, Web of Science), as well as trial registers. Randomized controlled trials of psychosocial interventions targeting specifically adolescents were included if they assessed outcomes at 1-year post-intervention or more. The Cochrane risk of bias-2 quality assessment tool was used. The primary outcome was depression, and studies were pooled using a standardised mean difference, with an associated 95% confidence interval, p-value, and I². The study protocol was pre-registered (CRD42022348668). Findings: A total of 57 reports (n= 46,678 participants) were included in the review. Psychosocial interventions led to small reductions in depressive symptoms, with a standardised mean difference (SMD) at 1-year of -0.08 (95%CI -0.20, -0.03, p=0.002, I²=72%), 18-months SMD=-0.12, 95% CI -0.22, -0.01, p=0.03, I²=63%) and 2-years SMD=-0.12 (95% CI -0.20, -0.03, p=0.01, I²=68%). Sub-group analyses indicated that targeted interventions produced stronger effects, particularly when delivered by trained mental health professionals (K=18, SMD=-0.24, 95% CI -0.38, -0.10, p=0.001, I²=60%). No effects were detected for anxiety at any assessment. Conclusion: Psychosocial interventions specifically targeting adolescents were shown to have small but positive effects on depression symptoms but not anxiety symptoms, which were sustained for up to 2 years. These findings highlight the potential population-level preventive effects if such psychosocial interventions become widely implemented in accessible settings such as schools.

Keywords: psychosocial, adolescent, interventions, depression, anxiety, meta-analysis, randomized controlled trial

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

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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

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Authors: Umair Shoukat Ali, Rashna Hoshang Sukhia, Mubassar Fida

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Introduction: The objective of the study was to compare outcomes in terms of Bleeding index (BI), Gingival Index (GI), and Orthodontic Plaque Index (OPI) with video graphics and plaque disclosing tablets (PDT) versus verbal instructions in adult orthodontic patients undergoing fixed appliance treatment (FAT). Materials and Methods: Adult orthodontic patients have recruited from outpatient orthodontic clinics who fulfilled the inclusion criteria and were randomly allocated to three groups i.e., video, PDT, and verbal groups. We included patients undergoing FAT for six months of both genders with all teeth bonded mesial to first molars having no co-morbid conditions such as rheumatic fever and diabetes mellitus. Subjects who had gingivitis as assessed by Bleeding Index (BI), Gingival Index (GI), and Orthodontic Plaque Index (OPI) were recruited. We excluded subjects having > 2 mm of clinical attachment loss, pregnant and lactating females, any history of periodontal therapy within the last six months, and any consumption of antibiotics or anti-inflammatory drugs within the last one month. Pre- and post-interventional measurements were taken at two intervals only for BI, GI, and OPI. The primary outcome of this trial was to evaluate the mean change in the BI, GI, and OPI in the three study groups. A computer-generated randomization list was used to allocate subjects to one of the three study groups using a random permuted block sampling of 6 and 9 to randomize the samples. No blinding of the investigator or the participants was performed. Results: A total of 99 subjects were assessed for eligibility, out of which 96 participants were randomized as three of the participants declined to be part of this trial. This resulted in an equal number of participants (32) that were analyzed in all three groups. The mean change in the oral hygiene indices score was assessed, and we found no statistically significant difference among the three interventional groups. Pre- and post-interventional results showed statistically significant improvement in the oral hygiene indices for the video and PDT groups. No statistically significant difference for age, gender, and education level on oral hygiene indices were found. Simple linear regression showed that the video group produced significantly higher mean OPI change as compared to other groups. No harm was observed during the trial. Conclusions: Visual aids performed better as compared to the verbal group. Gender, age, and education level had no statistically significant impact on the oral hygiene indices. Longer follow-ups will be required to see the long-term effects of these interventions. Trial Registration: NCT04386421 Funding: Aga Khan University and Hospital (URC 183022)

Keywords: oral hygiene, orthodontic treatment, adults, randomized clinical trial

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Authors: Paria Baharvand, Mohammad Reza Abbasi, Soha Namazi

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Introduction: Uremic pruritus (UP) is one of the major complaints in hemodialysis patients. The aim of this randomized clinical trial study was the evaluation of the anti-pruritus effect of Melatonin on hemodialysis patients with UP. Methods: This multi-centered double, blinded randomized clinical trial study was conducted on hemodialysis patients with UP that referred to the dialysis department of Imam Khomeini Hospital, Labbafinezhad Hospital and Ghiasi Hospital in Tehran, Iran, in 2018. Forty participants were enrolled and block randomization was performed by using a randomized list and divided into 2 groups of twenty patients. Evaluation of the 12-Item Pruritus Severity Scale (12-PSS), Visual analog scale (VAS), and Calculation of the affected body surface area for pruritus extent (BSA %) was performed every week. The Melatonin group received a 10 mg soft gel capsule, and the placebo group received a soft gel capsule placebo after dinner. For statistical analysis used by SPSS version 21(IRCT20180714040462N1). Results: 38 hemodialysis patients enrolled in this study. The mean age in the placebo group and in the Melatonin group was 55.88 ± 11.70 and 54.52 ± 13.00 years (p> 0.05). Also, 46% of all participants were female. Aspartate transaminase, alanine transaminase and C-reactive protein have significant differences between the two groups (p< 0.05). VAS score reduction in the two groups had a statistically significant (CI 95% = -1.71, P= 0.015(.The results of BSA% showed Melatonin had a significant effect on the decrease of the pruritus extent compared to placebo (CI 95% = -22.82, P= 0.001(. Conclusion: According to the results of this study and the preliminary effects of Melatonin on uremic pruritus, we suggest performing advanced clinical trials studies.

Keywords: Melatonin, Uremic Pruritus, hemodialysis, anti-pruritus

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Authors: Razieh Karimian, Kim Burton, Mohammad Mehdi Naghizadeh, Maryam Karimian

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Introduction: Habitual upper body postures are associated with online learning during the COVID-19 pandemic. This study explored whether adding an exercise routine to an ergonomic advice intervention improves these postures. Methods: In this randomized trial, 42 male adolescent students with a forward head posture were randomly divided into two equal groups, one allocated to ergonomic advice alone and the other to ergonomic advice plus an exercise routine. The angles of forward head, shoulder, and back postures were measured with a photogrammetric profile technique before and after the 8-week intervention period. Findings: During home quarantine, 76% of the students used their mobile phones, while 35% used a table-chair-computer for online learning. While significant reductions of the forward, shoulder, and back angles were found in both groups (P < 0.001), the effect was significantly greater in the exercise group (P < 0.001: forward head, shoulder, and back angles reduced by some 9, 6, and 5 degrees respectively, compared with 4 degrees in the forward head, and 2 degrees in the shoulder and back angles for ergonomic advice alone. Conclusion: The exercise routine produced a greater improvement in habitual upper body postures than ergonomic advice alone, a finding that may extend beyond online learning at home.

Keywords: randomized trial, online learning, adolescent, posture, exercise, ergonomic advice

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Authors: Hasanzadeh Tahraband F., Kheirkhah M.

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The trauma resulting from abortion causes fear, frustration, inability, lack of self-confidence, and psychological distress in women. The present study was conducted to determine the effect of midwifery counseling based on the Gamble approach on coping strategies of women with abortion. This randomized controlled clinical trial was conducted on women with abortions in April–October 2021, Karaj, Iran. Ninety-six eligible women were randomly assigned to two 48-member groups with 4, 6, and 8 blocks. The women in the intervention group participated in two 45-75-minute Gamble counseling programs. They were asked to fill out the demographic and fertility information questionnaire before the intervention and the cope operations preference inquiry questionnaire before, immediately (in the 4-6th week of the study), and three months after the intervention. The analysis of the data was done through Chi-square, independent sample t-test. The significance level was considered P<0.05. The results showed that the differences between the two groups before the intervention were not statistically significant in terms of demographic and fertility variables (P>0.05). However, the total mean score of the problem-focused dimension in 3-month post-abortion (97/34±8/69) and the emotion-focused dimension in 4-6 weeks and 3-month post-abortion (34/14±3/48 and 32/41±3/41) in the intervention group was significantly different from the control group (P<0.001). According to the results of the repeated measures ANOVA, the level of coping and its dimensions significantly changed in the intervention group over time (P<0.001). The results of the present study showed that Gamble counseling promoted the problem-focused dimension score and reduced the emotion-focused dimension score in women with abortion. It is recommended that Gamble counseling should be used as midwife-led counseling to increase coping strategies and reduce the psychological distress of women who have experienced abortion.

Keywords: midwife-led counseling, coping strategies, post-abortion, psychological distress, Iran

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

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

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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

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Authors: Nahla Al-Bayyari, Rae’d Hailat

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Vitamin D deficiency and overweight are common in women suffering from polycystic ovary syndrome (PCOS). Weight gain in PCOS is an important factor for the development of menstrual dysfunction and signs of hyperandrogenism and alopecia. Features of PCOS such as oligomenorrhea can be predicted by anthropometric measurements as body mass index (BMI). Therefore, the aim of this trial was to study the effect of 50,000 IU/week of vitamin D₃ supplementation on the body composition and on the anthropometric measurements of overweight women with PCOS and to examine the impact of this effect on ovaries ultrasonography and menstrual cycle regularity. The study design was a prospective randomized, double-blinded placebo-controlled clinical trial conducted on 60 overweight Jordanian women aged (18-49) years with PCOS and vitamin D deficiency. The study participants were divided into two groups; vitamin D group (n = 30) who were assigned to receive 50,000 IU/week of vitamin D₃ and placebo group (n = 30) who were assigned to receive placebo tablets orally for 90 days. The anthropometric measurements and body composition were measured at baseline and after treatment for the PCOS and vitamin D deficient women. Also, assessment of the participants’ picture of ovaries by ultrasound and menstrual cycle regulatory were performed before and after treatment. Results showed that there were no significant (p > 0.05) differences between the placebo and vitamin D group basal 25(OH)D levels, body composition and anthropometric parameters. After treatment, vitamin D group serum levels of 25(OH)D increased (12.5 ± 0.61 to 50.2 ± 2.04 ng/mL, (p < 0.001), and decreased (50.2 ± 2.04 to 48.2 ± 2.03 ng/mL, p < 0.001) after 14 days of vitamin D₃ treatment cessation. There were no significant changes in the placebo group. In the vitamin D group, there were significant (p < 0.001) decreases in body weight, BMI, waist, and hip circumferences and fat mass. In addition, there were significant increases (p < 0.05) in fat free mass and total body water. These improvements in both anthropometric and body composition as well as in 25(OH)D concentrations, resulted in significant improvements in the picture of PCOS women ovaries ultrasonography and in menstrual cycle regularity, where nearly most of them (93%) had regular cycles after vitamin D₃ supplementation. In the placebo group, there were only significant decreases (p < 0.05) in waist and hip circumferences. It can be concluded that vitamin D supplementation improving serum 25(OH)D levels and PCOS prognosis by reducing body weight of overweight PCOS women and regulating their menstrual cycle.

Keywords: anthropometric, overweight, polycystic ovary syndrome, vitamin D₃

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Authors: Niu Shu Fen

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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

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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

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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

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Authors: Mostafa Solati

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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

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

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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

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Authors: R. Botrugno, S Basyuni, G. Nugent, I. Jenkyn, A. Ferro, H. Bennett, C. Hjalmarsson, J. Chu, V. Santhanam

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This trainee led randomised controlled trial (RCT) aims to assess various outcomes for resorbable versus non-resorbable sutures for traumatic lacerations to the face. Within this trial of resorbable versus non-resorbable sutures for traumatic lacerations of the face (TORNFace), patient recruitment was facilitated by trainees who were employed at an NHS University Teaching Hospital in the United Kingdom. The trainees received appropriate training prior to recruiting patients for the trial. This included the completion of a national research e-learning module and face-to-face training that was provided locally. The locally delivered training provided an understanding of the eligibility criteria for the trial and the consent process. Existing trainee skills were utilised involving clinical photography to record baseline data and delivering the intervention based on the treatment arm selected. Eligible patients who required primary closure of traumatic lacerations of the face were randomised into one of two treatment arms. These comprised of resorbable (vicryl rapide) or non-resorbable sutures (ethilon). Primarily the cosmetic outcome was assessed. Secondary outcomes included: complications rates, health care economics, and patient-reported outcomes. Remote follow-up of recruited patients utilised photographs of the facial laceration which had received the intervention. These took place at 1 week, 3 months and 6 months post-intervention. This study aims to demonstrate an example of trainee-led research within the specialty of oral and maxillofacial surgery. The available data for the randomised controlled trial will also be presented.

Keywords: laceration, suture, trauma, trial

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Authors: Zenah Gheblawi, Susan Armijo-Olivo, Elisa B. Pelai, Vaishali Sharma, Musa Tashfeen, Angela Fung, Francisca Claveria

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Due to physiological differences between men and women, pain is experienced differently between the two sexes. Chronic pain disorders, notably temporomandibular disorders (TMDs), disproportionately affect women in diagnosis, and pain severity in opposition of their male counterparts. TMDs are a type of musculoskeletal disorder that target the masticatory muscles, temporalis muscle, and temporomandibular joints, causing considerable orofacial pain which can usually be referred to the neck and back. Therapeutic methods are scarce, and are not TMD-centered, with the latest research suggesting that subjects with chronic musculoskeletal pain disorders have abnormal alterations in the grey matter of their brains which can be remedied with exercise, and thus, decreasing the pain experienced. The aim of the study is to investigate the effects of exercise therapy in TMD female patients experiencing chronic jaw pain and to assess the consequential effects on brain activity. In a randomized controlled trial, the effectiveness of an exercise program to improve brain alterations and clinical outcomes in women with TMD pain will be tested. Women with chronic TMD pain will be randomized to either an intervention arm or a placebo control group. Women in the intervention arm will receive 8 weeks of progressive exercise of motor control training using visual feedback (MCTF) of the cervical muscles, twice per week. Women in the placebo arm will receive innocuous transcutaneous electrical nerve stimulation during 8 weeks as well. The primary outcomes will be changes in 1) pain, measured with the Visual Analogue Scale, 2) brain structure and networks, measured by fractional anisotropy (brain structure) and the blood-oxygen level dependent signal (brain networks). Outcomes will be measured at baseline, after 8 weeks of treatment, and 4 months after treatment ends and will determine effectiveness of MCTF in managing TMD, through improved clinical outcomes. Results will directly inform and guide clinicians in prescribing more effective interventions for women with TMD. This study is underway, and no results are available at this point. The results of this study will have substantial implications on the advancement in understanding the scope of plasticity the brain has in regards with pain, and how it can be used to improve the treatment and pain of women with TMD, and more generally, other musculoskeletal disorders.

Keywords: exercise therapy, musculoskeletal disorders, physical therapy, rehabilitation, tempomandibular disorders

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Authors: Ajay Agrawal, Pritha Basnet, Achala Thakur, Pappu Rizal, Rubina Rai

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Context: Rapid expulsion of fetus in intrauterine fetal death (IUFD) is usually requested without any medical grounds for it. So; an efficient, safe method for induction of labor (IOL) is required. Objective: To determine if pre-treatment with mifepristone followed by IOL with misoprostol in late IUFD is more efficacious. Methods: We conducted a randomized controlled trial in 100 patients. Group-A women received single oral dose of 200 mg mifepristone, followed by induction with vaginal misoprostol after 24-hour. Group-B women were induced only with vaginal misoprostol. In each group 5 dose of misoprostol was used 4 hourly. If first cycle was unsuccessful, after break of 12 hour, second course of misoprostol was started. The primary outcome was a measure of induction to delivery time and vaginal delivery within 24 hours. Secondary outcome was to measure need of oxytocin and complications. Results: Maternal age, parity and period of gestation were comparable between groups. Number of misoprostol dose needed in group A was significantly less than group B. Mann Whitney U test showed, women in group A had significantly earlier onset of labor, however total induction to delivery interval was not significant. In group-A, 85.7% delivered within 24 hours of first dose of misoprostol while in group-B 70% delivered within 24 hour (p=0.07). More women in Group B required oxytocin. Conclusion: Pretreatment with mifepristone before IOL following late IUFD is an effective and safe regimen. It appears to shorten the duration of induction to onset of labor.

Keywords: induction of labor, intrauterine fetal death, mifepristone, misoprostol

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Authors: Wenru Wang

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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

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Authors: Woolfrey K., Woolfrey M., Bolton C. L., Warchuk D.

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Objectives: Osteoarthritis is the most common joint disease of adults worldwide. Despite total knee arthroplasty (TKA) demonstrating high levels of success, 20% of patients report dissatisfaction with their result. VOXX Wellness Stasis Socks are embedded with a proprietary pattern of neuro-receptor activation points that have been proven to activate a precise neuro-response, according to the pattern theory of haptic perception, which stimulates improvements in pain and function. The use of this technology in TKA patients may prove beneficial as an adjunct to recovery as many patients suffer from deficits to their proprioceptive system caused by ligamentous damage and alterations to mechanoreceptors during the procedure. We hypothesized that VOXX Wellness Stasis Socks are a safe, cost-effective, and easily scalable strategy to support TKA patients through their recovery. Design: Double-blinded, placebo-controlled randomized trial. Participants: Patients scheduled to receive TKA were considered eligible for inclusion in the trial. Interventions: Intervention group (I): VOXX Wellness Stasis socks containing receptor point-activation technology. Control group (C): VOXX Wellness Stasis socks without receptor point-activation technology. Sock use during the waking hours x 6 weeks. Main Outcome Measures: Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) questionnaire completed at baseline, 2 weeks, and 6 weeks to assess pain, stiffness, and physical function. Results: Data analysis using SPSS software. P-values, effect sizes, and confidence intervals are reported to assess clinical relevance of the finding. Physical status classifications were compared using t-test. Within-subject and between-subject differences in the mean WOMAC were analyzed by ANOVA. Effect size was analyzed using Cramer’s V. Consistent improvement in WOMAC scores for pain and stiffness at 2 weeks post op in the I over the C group. The womac scores assessing physical function showed a consistent improvement at both 2 and 6 weeks post op in the I group compared to C group. Conclusions: VOXX proved to be a low cost, safe intervention in TKA to help patients improve with regard to pain, stiffness, and physical function. Disclosures: None

Keywords: osteoarthritis, RCT, pain management, total knee arthroplasty

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

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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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Authors: Maryam Bordbar, Yaser Mokhayeri, Sajjad Roosta, Fatemeh Ghasemi, Saeed Choobkar, Hamidreza Nikbakht, Ebrahim Falahi

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Objective: Diabetes mellitus type 2 is the most common metabolic disorder that is growing exponentially worldwide. Satureja Khuzestanica Jamzad is a native plant of Iran that grows widely in the south of Iran. Its antimicrobial, antioxidant, anti-inflammatory and pain-relieving effects have been documented in animal studies. The purpose of this study is to investigate the effect of consumption daily S. khuzestanica on inflammatory and antioxidant indicators in type 2 diabetic patients. Methods and Materials: In a double-blind, placebo-controlled clinical trial, 67 patients with type 2 diabetes were included and divided into two groups. One group received S. khuzestanica (capsule containing 500 mg) and the other group received placebo (500 mg talcum powder) once a day for 12 weeks. After the intervention, the inflammatory and antioxidant indicators of the two groups were compared. Results: In comparison to placebo groups, there was a significant difference in levels of total antioxidant capacity, superoxide dismutase, catalase, glutathione reductase, and glutathione peroxidase; these antioxidant indicators were higher in the intervention group (P<0.05). Moreover, a considerable decrease in weight, CRP and IL-6 levels were observed in patients in the S.Khuzestanica group. Conclusion: Our findings may provide novel complementary treatments without adverse effects for diabetes complications.

Keywords: Satureja khuzestanica Jamzad, diabetes mellitus, antioxidant indicators, IL-6, C-reactive protein

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Authors: Xinli Chi, Xiaoqi Wei

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

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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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Authors: Priyanka Patil, Logan Manikam

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Background: The first 1000 days of life are a critical window and can result in adverse health consequences due to inadequate nutrition. South-Asian (SA) communities face significant health disparities, particularly in maternal and child health. Community-based interventions, often employing Participatory-Learning and Action (PLA) approaches, have effectively addressed health inequalities in lower-income nations. The aim of this study was to assess the feasibility of implementing a PLA intervention to improve infant feeding and care practices in SA communities living in London. Methods: Comprehensive analyses were conducted to assess the feasibility/fidelity of this pilot randomized controlled trial. Summary statistics were computed to compare key metrics, including participant consent rates, attendance, retention, intervention support, and perceived effectiveness, against predefined progression rules guiding toward a definitive trial. Secondary outcomes were analyzed, drawing insights from multiple sources, such as The Children’s-Eating-Behaviour Questionnaire (CEBQ), Parental-Feeding-Style Questionnaires (PFSQ), Food-diary, and the Equality-Impact-Assessment (EIA) tool. A video analysis of children's mealtime behavior trends was conducted. Feedback interviews were collected from study participants. Results: Process-outcome measures met predefined progression rules for a definitive trial, which deemed the intervention as feasible and acceptable. The secondary outcomes analysis revealed no significant changes in children's BMI z-scores. This could be attributed to the abbreviated follow-up period of 6 months, reduced from 12 months, due to COVID-19-related delays. CEBQ analysis showed increased food responsiveness, along with decreased emotional over/undereating. A similar trend was observed in PFSQ. The EIA tool found no potential discrimination areas, and video analysis revealed a decrease in force-feeding practices. Participant feedback revealed improved awareness and knowledge sharing. Conclusion: This study demonstrates that a co-adapted PLA intervention is feasible and well-received in optimizing infant-care practices among South-Asian community members in a high-income country. These findings highlight the potential of community-based interventions to enhance health outcomes, promoting health equity.

Keywords: child health, childhood obesity, community-based, infant nutrition

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

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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

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Authors: Firjeeth C. Paramba, Vamanjore A. Naushad, Nishan K. Purayil, Osama H. Mohammed, Prem Chandra

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Background: Fever is a common problem in adults visiting the emergency department. Extensive studies have been done in children comparing the efficacy of various antipyretics. However, studies on the efficacy of antipyretic drugs in adults are very scarce. To the best of our knowledge, no controlled trial has been carried out comparing the antipyretic efficacy of paracetamol (oral and intravenous) and intramuscular diclofenac in adults. Methods: In this parallel-group, open-label trial, participants aged 14–75 years presenting with fever who had a temperature of more than 38.5°C were enrolled and treated. Participants were randomly allocated to receive treatment with 1,000 mg oral paracetamol (n=145), 1,000 mg intravenous paracetamol (n=139), or 75 mg intramuscular diclofenac (n=150). The primary outcome was degree of reduction in mean oral temperature at 90 minutes. The efficacy of diclofenac versus oral and intravenous paracetamol was assessed by superiority comparison. Analysis was done using intention to treat principles. Results: After 90 minutes, all three groups showed a significant reduction in mean temperature, with intramuscular diclofenac showing the greatest reduction (−1.44 ± 0.43, 95% confidence interval [CI] −1.4 to −2.5) and oral paracetamol the least (−1.08 ± 0.51, 95% CI −0.99 to −2.2). After 120 minutes, there was a significant difference observed in the mean change from baseline temperature between the three treatment groups (P, 0.0001). Significant changes in temperature were observed in favor of intramuscular diclofenac over oral and intravenous paracetamol at each time point from 60 minutes through 120 minutes inclusive. Conclusion: Both intramuscular diclofenac and intravenous paracetamol showed superior antipyretic activity than oral paracetamol. However, in view of its ease of administration, intramuscular diclofenac can be used as a first-choice antipyretic in febrile adults in the emergency department.

Keywords: antipyretic, intramuscular, intravenous, paracetamol, diclofenac, emergency department

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Authors: Anna Rinaldi, Pierfrancesco Dellino

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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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Authors: Kamal Tolani, Sandeep Kumar, Rohit Luthra, Ankit Dadhania, Krishnaprasad K., Ram Gupta, Deepa Joshi

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Background: Post-operative analgesia remains a clinical challenge, with central and peripheral sensitization playing a pivotal role in treatment-related complications and impaired quality of life. Centrally acting opioids offer poor risk benefit profile with increased intensity of gastrointestinal or central side effects and slow onset of clinical analgesia. The objective of this study was to assess the clinical feasibility of induction and maintenance therapy with Tapentadol Nasal Spray (NS) in moderate to severe acute post-operative pain. Methods: Phase III, randomized, active-controlled, non-inferiority clinical trial involving 294 cases who had undergone surgical procedures under general anesthesia or regional anesthesia. Post-surgery patients were randomized to receive either Tapentadol NS 45 mg or Tramadol 100mg IV as a bolus and subsequent 50 mg or 100 mg dose over 2-3 minutes. The frequency of administration of NS was at every 4-6 hours. At the end of 24 hrs, patients in the tramadol group who had a pain intensity score of ≥4 were switched to oral tramadol immediate release 100mg capsule until the pain intensity score reduced to <4. All patients who had achieved pain intensity ≤ 4 were shifted to a lower dose of either Tapentadol NS 22.5 mg or oral Tramadol immediate release 50mg capsule. The statistical analysis plan was envisaged as a non-inferiority trial involving comparison with Tramadol for Pain intensity difference at 60 minutes (PID60min), Sum of Pain intensity difference at 60 minutes (SPID60min), and Physician Global Assessment at 24 hrs (PGA24 hrs). Results: The per-protocol analyses involved 255 hospitalized cases undergoing surgical procedures. The median age of patients was 38.0 years. For the primary efficacy variables, Tapentadol NS was non-inferior to Inj/Oral Tramadol in relief of moderate to severe post-operative pain. On the basis of SPID60min, no clinically significant difference was observed between Tapentadol NS and Tramadol IV (1.73±2.24 vs. 1.64± 1.92, -0.09 [95% CI, -0.43, 0.60]). In the co-primary endpoint PGA24hrs, Tapentadol NS was non–inferior to Tramadol IV (2.12 ± 0.707 vs. 2.02 ±0.704, - 0.11[95% CI, -0.07, 0.28). However, on further assessment at 48hr, 72 hrs, and 120hrs, clinically superior pain relief was observed with the Tapentadol NS formulation that was statistically significant (p <0.05) at each of the time intervals. Secondary efficacy measures, including the onset of clinical analgesia and TOTPAR, showed non-inferiority to Tramadol. The safety profile and need for rescue medication were also similar in both the groups during the treatment period. The most common concomitant medications were anti-bacterial (98.3%). Conclusion: Tapentadol NS is a clinically feasible option for improved compliance as induction and maintenance therapy while offering a sustained and persistent patient response that is clinically meaningful in post-surgical settings.

Keywords: tapentadol nasal spray, acute pain, tramadol, post-operative pain

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

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

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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

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