Single-blind Randomized Control Trial Research Articles

Effect of a dietary and exercise intervention in women with overweight and obesity undergoing fertility treatments: protocol for a randomized controlled trial

BackgroundDistinct molecular, inflammatory, and metabolic signatures are present in oocytes and follicular fluid derived from women with obesity when compared to those derived from normal weight women, which suggest existing signals that may program future offspring for metabolic diseases. This study aims to assess the feasibility and efficacy of a peri-conception nutrition and exercise intervention on mitigating obesity-associated changes in oocyte gene expression profiles and follicular fluid metabolites.MethodsThis single blinded randomized control trial will include 120 women with a BMI of 25–45 kg/m2, ≥21 years of age, and undergoing in vitro fertilization (IVF) treatments. Participants will be randomized to standard of care (N = 60) or an intervention group (N = 60) in a block design by polycystic ovary syndrome status. The intervention will combine a dietary component (Mediterranean meal plan) with exercise prescription following the Physical Activity Guidelines for Americans. Participants will be assessed pre- and post-intervention. The standard of care group will be offered to join the intervention group if the IVF treatments are unsuccessful as a cross over design. Recruitment is anticipated to start in July of 2021. Primary outcomes will include single oocyte gene expression profiles and follicular fluid metabolites. Mann-Whitney U nonparametric tests will be used to assess potential differences for each stratum. Follicular fluid and serum metabolites will be analyzed using a one-factor Analysis of Covariance (ANCOVA) at four levels, pair-wise comparisons using Tukey-Kramer post-hoc tests will be used to identify groups whose means differ significantly while retaining the family-wise error rate at 5%. When the design is balanced, two-way Analysis of Variance (ANOVA), or non-parametric Friedman test will be used in data analysis. Additionally, general linear models and ANCOVA may be used to control for covariates. Significance will be set at p < 0.05. Findings will be disseminated via peer-reviewed manuscripts and presentations at scientific conferences.DiscussionThis study will provide novel data and key information on the impact of a dietary and exercise intervention on oocyte gene expression and follicular fluid content. Results will demonstrate the potential of such intervention in mitigating obesity-induced changes in oocyte gene expression and follicular fluid metabolites.Trial registrationClinicalTrials.gov (NCT04273048): submitted November 13, 2019; posted February 17, 2020.

Endoscopic Versus Microscopic Stapedotomy: A Single-Blinded Randomized Control Trial.

To demonstrate non-inferiority of endoscopic stapedotomy to microscopic stapedotomy for the treatment of otosclerosis. Single-blinded randomized control trial. Tertiary, academic otology-neurotology practice. Adult subjects with a diagnosis of otosclerosis and a preoperative air-bone gap (ABG) more than or equal to 20 dB undergoing primary stapedotomy. Endoscopic or microscopic stapedotomy. Primary audiometric outcome was postoperative ABG. Secondary audiometric outcomes included speech reception threshold (SRT), word recognition score (WRS), bone- and air-conduction pure tone averages (PTA), change in ABG, and ABG closure rates to less than or equal to 10 dB and less than or equal to 20 dB. Twenty-two patients were recruited. Eleven patients underwent endoscopic stapedotomy and 11 underwent microscopic stapedotomy. The endoscopic group was non-inferior to the microscopic group in terms of postoperative audiometric outcomes (endoscope versus microscope, p-value): ABG (8.1 dB versus 8.1 dB, <0.001), SRT (27.7 dB versus 25.9 dB, <0.001), WRS (92% at 65 dB versus 98% at 62 dB, <0.001), air-conduction PTA (33.5 dB versus 30.8 dB, <0.01), and change in ABG (23.0 dB versus 20.7 dB, <0.0001). ABG closure rates to less than or equal to 10 dB (72.7% versus 81.2%, p = 1.0) and less than or equal to 20 dB (90.9% versus 100%, p = 1.0) were not significantly different. There was no significant difference in operative time, necessity of scutum curettage, or postoperative dysgeusia. No patients required chorda tympani sacrifice. Preoperative tinnitus resolved in three patients in each group postoperatively. This study is the first randomized control trial to demonstrate non-inferiority of endoscopic to microscopic stapedotomy.

O8 Tracking wound infection with smartphone technology (twist): a randomised controlled trial in emergency surgery patients

Abstract Introduction Surgical site infections (SSI) complicate 2%–10% of general surgery cases, and represent a significant burden on acute healthcare services. We aim to investigate if a smartphone-delivered wound assessment tool results in earlier treatment. Method This parallel, single-blinded randomised control trial enrolled adult emergency abdominal surgery patients in two tertiary hospitals (ClinicalTrials.gov number, NCT02704897). Patients were randomised (1:1 ratio) between standard postoperative care and additional access to a smartphone-delivered wound assessment tool for 30-days postoperatively. Patients routinely submitted wound questionnaires and photos for surgical review at postoperative days 3, 7, and 15. The primary outcome measure was time-to-diagnosis of SSI (CDC definition) within 30 postoperative days. Result 492 patients undergoing emergency surgery were randomised (smartphone intervention = 223; standard care = 269). There was no significant difference (P = 0.513) in the 30-day SSI rate between trial arms: 21 (9.4%) in smartphone vs 20 (7.4%) in standard care. While the mean time-to-diagnosis of SSI was 9.3 days (SD = 6.3) in the smartphone group, and 11.8 days (SD = 6.7) in the control group, this did not demonstrate a significant difference for the primary outcome (P = 0.255). However, patients in the smartphone group had 3.7-fold higher odds to be diagnosed in first 7 postoperative days (95% CI: 1.02 to 13.51, P = 0.043). Conclusion Digital patient-driven postoperative wound follow-up can be feasibly delivered in a broad cohort of emergency surgery patients. This can facilitate triage of patients to the appropriate level of assessment required, allowing diagnosis of SSI earlier in the postoperative period. Take-home Message Digital patient-driven postoperative wound follow-up can be feasibly delivered in a broad cohort of emergency surgery patients. This can facilitate triage of patients to the appropriate level of assessment required, allowing diagnosis of SSI earlier in the postoperative period.

A three-arm single blind randomised control trial of na\xefve medical students performing a shoulder joint clinical examination

BackgroundTechnological advances have previously been hailed as a new dawn in Higher Education, with the advent of ‘massive open online courses’ (MOOCs) and online learning. Virtual platforms have potential advantages such as accessibility and availability but simply transferring educational material to the online environment may not ensure high quality learning. Clinical examination is a fundamental principle of medical assessment, and this study aimed to assess the role of technology in teaching these skills.Aims/objectivesTo determine whether three teaching modalities were of equal efficacy in teaching examination of the shoulder joint to naïve medical students.MethodsSixty-seven pre-clinical medical students naïve to large joint examination were recruited. Participants completed a learning style questionnaire and were then block randomised to three study: textbook study, face-to-face seminar, or video tutorial via online platform. The same examination technique was taught in all groups, with the intervention being the method of delivery All second year students were eligible for inclusion. The single exclusion criteria was previous exposure to clinical examination teaching. Students were assessed using a standardised scoring system at baseline (pre-intervention), and days 5 and 19 post-intervention (maximum score 30). Assessors were blinded to group allocation. The primary outcome was assessment score at day 5 post intervention.ResultsThere was no difference between the three groups at baseline assessment (mean scores 2.4 for textbook, 2.8 for face-to-face, and 3.1 for video; p = 0.267). Mean post-intervention scores were 16.5 textbook, 25.5 face-to-face, and 22.4 video (p < 0.001, η2 = .449). There was no change between day 5 and day 19 post-intervention assessment scores in any group (p = 0.373), Preferred learning style did not affect scores (p = 0.543).ConclusionFace-to-face teaching was the most effective method for teaching clinical examination of the shoulder. Technology can potentially increase accessibility and remove geographic barriers, but is not as effective if teaching techniques are simply mirrored in an online format.Online platforms allow in depth data analysis of how learners interact with educational material and this may have value in improving the design of online educational materials, and is a potential area for further research.

Randomised clinical trial: Effect of administering platelet-rich fibrin to autologous fat tissue in injection laryngoplasty for vocal cord paralysis

The vocal cord in humans is essential in producing voice used in communication and interaction between us. Vocal cord paralysis causes dysphonia, which interferes with communication, causing disruptions towards social activity and daily activities. One of the managements for vocal cord paralysis is medialization and augmentation of the vocal cord through injection laryngoplasty. Autologous fat is one of the best fillers used in this procedure, but it is highly absorbable and can be reabsorbed very quickly when injected into body tissues. Platelet Rich Fibrin (PRF) is a biomaterial consisting of growth factors that are thought to improve fat tissue viability by increasing adipogenesis and angiogenesis. Improvement in fat viability will improve clinical outcomes after the laryngoplasty procedure, potentially reducing the number of repeated injections needed to achieve a satisfactory resolution to vocal cord paralysis. The study evaluates a combination of PRF and autologous microlobular fat compared with autologous microlobular fat alone on laryngoplasty. This single-blinded randomised control trial recruit a total of 18 patients, which are then randomised into the treatment and control groups. The evaluation was done via computerized acoustic analysis/Multidimensional Voice Program (MDVP) parameters and maximum phonation time. The MDVP results and maximum phonation time in both groups showed clinical improvement after the operation with no statistically significant differences.

The Effects of Immersive Virtual Reality in Reducing Public Stigma of Mental Illness in the University Population of Hong Kong: Randomized Controlled Trial.

BackgroundPublic stigma in mental health often brings various adverse effects on people with mental illness. Researchers have been developing different interventions in combating public stigma.ObjectiveThis study investigates the effects of immersive virtual reality (IVR) in reducing the public stigma of mental illness using a single-blinded randomized control trial.MethodsA pre-post experimental design with a 1-week follow-up was conducted. Participants (N=206) were recruited through the mass mail system of The Chinese University of Hong Kong and randomized into 3 conditions: immersive animation, text, and control. In the immersive animation condition (n=72), participants experienced the simulation of daily life and the stigma experienced as an animated story protagonist with mixed anxiety and depressive disorder with IVR. In the text condition (n=65), participants experienced an identical story to the immersive animation condition with first-person audio narration using the same virtual reality headset. In the control condition (n=69), participants watched a video about planets with IVR. All participants received interventions with a researcher-assisted Oculus Go virtual reality headset. Participants’ public stigma was measured through self-administered online questionnaires and compared across conditions and at different time points using repeated measures analysis of variance. Simple and sequential mediation analyses on the relationship of condition (immersive animation vs text) and follow-up public stigma with possible mediators, including sense of embodiment and story transportation, were conducted using PROCESS.ResultsPublic stigma did not differ significantly across conditions at pre-experiment (P>.99). In the immersive animation and text conditions, public stigma was significantly reduced at postexperiment and at the 1-week follow-up compared to pre-experiment (all with P<.001). Public stigma in the control condition at postexperiment and follow-up remained unchanged compared with pre-experiment (P=.69). Immersive animation had significantly lower public stigma than the control at postexperiment (P=.003) and follow-up (P=.02). Text also had lower public stigma than the control at postexperiment (P=.007) and follow-up (P=.03). However, immersive animation did not significantly differ from text in public stigma at postexperiment and follow-up (both P>.99). In simple mediation models, both sense of embodiment (95% CI –0.22 to 0.46) and story transportation (95% CI –0.18 to 0.00) were not significant mediators. In the sequential mediation model, both sense of embodiment and story transportation were significant sequential mediators. Sense of embodiment was positively associated with story transportation (P<.001), while story transportation was negatively associated with public stigma (P<.001). The indirect effect of the sequential mediation model was significant (95% CI –0.38 to –0.11).ConclusionsThis study provides novel findings and a rigorous comparison in understanding the effects of IVR on public stigma. The findings showed that IVR and text with audio narration performed similarly and significantly in stigma reduction. Sense of embodiment and story transportation were found to be sequentially associated with public stigma reduction.Trial RegistrationCentre for Clinical Research and Biostatistics Clinical Trial Registry CUHK_Ccrb00638; https://www2.ccrb.cuhk.edu.hk/registry/public/632

Impact of yoga intervention on menopausal symptoms-specific quality of life and changes in hormonal level among menopausal women.

The menopause transition is experienced by women often involves troublesome symptoms due to changes in the level of reproductive hormones. Non-hormonal therapies are more commonly accepted by women than hormonal therapy for coping with the climacteric symptoms. The aim of the study was to evaluate the effects of yoga practice on menopausal symptoms, specific quality of life, and changes in hormonal levels among menopausal women. A single-blinded randomized control trial was conducted among 80 participants aged 40 of 50 years and was randomly divided into two study arms, that is, Sudarshan Kriya Yoga (SKY) and brisk walking intervention, to find the effect on the hormonal changes and menopausal quality of life (measured by MENQOL tool). The significant improvements in the outcome measures were measured by using repeated measures analysis of variance and McNemar's test. Significant improvements in the menopausal-specific quality of life were observed in the domain of vasomotor, psychosocial, and physical symptoms (p < 0.05). The antioxidant enzymes (superoxide dismutase and glutathione peroxidase (GPX) were significantly elevated after 1 year of regular practice of SKY compared to walking intervention (p < 0.05). In contrast, no significant improvement was observed in follicle-stimulating hormone and dehydroepiandrosterone sulfate levels. The women reported no adverse events after SKY practice or brisk walking. The study concluded that 1 year of SKY practice could be one of the preferred non-hormonal, lifestyle-modifying regimens for improving the overall quality of life in menopausal women.

Safety and Efficacy of Low-dose Selective Spinal Anesthesia with Bupivacaine and Fentanyl as Compared to Intravenous Sedation and Port-Site Infiltration for Outpatient Laparoscopic Tubal Ligation: A Randomized Controlled Trial.

Background:Selective spinal anesthesia has been safely applied for short-duration outpatient gynecological laparoscopic procedure. However, this anesthesia technique is often inadequate and not tolerated by awake patients due to pneumoperitoneum and visceral manipulation.Aims:We aimed to conduct a study to compare spinal anesthesia with bupivacaine, fentanyl, and i.v. sedation with i.v. sedation and laparoscopic port-site infiltration with local anaesthetic in outpatient laparoscopic tubal ligation procedures.Settings and Design:100 female patients posted for elective surgeries were recruited for a prospective single blind randomised control trial in a tertiary care center in two groups.Materials and Methods:In Group S, patients receive intrathecal 3 mg hyperbaric bupivacaine 0.5% plus 20 microgram fentanyl along with intravenous (i.v.) fentanyl at 1μg.kg-1.h-1 and in Group C i.v. fentanyl at 1μg.kg-1.h-1 along with laparoscopic port site infiltration with 0.5% bupivacaine. Postoperatively, overall patient satisfaction, visual analog score (VAS) score, duration of motor blockade, sensory blockade, and time to attain discharge criteria and any adverse.Statistical Analysis:Continuous variables between the groups were compared by the independent t-test and Wilcoxon rank sum. Chi-square and Fisher exact test used for the categorical value.Results:Overall VAS was significantly lower and patient satisfaction was higher in Group S than Group C. Time to oral intake was significantly prolonged in Group C 126.33 (±29.54) compared to group S 110.81 (±29.54). The requirement of total rescue analgesia (fentanyl) was significantly higher in Group C 2.0 (±0.6) μg.kg-1 compared to group S 0.79 (±0.53) μg.kg-1. Incidence of postoperative nausea vomiting (PONV) was significantly greater in Group C while incidence of pruritus was significantly greater in Group S.Conclusion:Low-dose intrathecal anesthesia with 3 mg bupivacaine and 20 μg fentanyl provided better analgesia, patient satisfaction and with less opioids consumption.

Transcranial direct current stimulation and repetitive functional task-oriented programme for upper limb functional rehabilitation in stroke survivors

Introduction Recovery of upper limb motor function remains a major challenge to stroke rehabilitation experts and stroke survivors alike. Stimulation of the motor cortex by noninvasive brain stimulators and therapy focused on repetitive functional activities can increase upper limb functioning after stroke. Hence, this study was designed to determine therapeutic efficacy of transcranial direct current stimulation (tDCS) and repetitive functional task-oriented programme (RFTOP) for upper limb functional rehabilitation in stroke survivors. Materials and Methods A single-blind randomized control trial involving 78 individuals with sub-acute and chronic stroke. They were randomized into three groups: Group 1: Anodal tDCS + RFTOP; Group 2: Cathodal tDCS + RFTOP; Group 3: RFTOP only. Participants had two sessions of therapy in a week for six weeks. Upper limb function was assessed using Fugl-Meyer Assessment Upper Extremity (FMA-UE) and Box and Block Test (BBT). Significance was set at p < 0.05. Results Baseline comparison of the groups showed no significant difference (FMA-UE: p = 0.237; BBT: p = 0.183). All groups showed statistical significant difference between baseline and post intervention in scores of FMA-UE (p ≤ 0.001) and BBT (p < 0.001). Mean difference comparison showed statistical significant difference among groups for FMA-UE hand domain (p = 0.009) and BBT (p = <0.001). Post hoc analysis showed the difference among the groups was between anodal against cathodal and anodal against control. Conclusion tDCS and RFTOP were efficacious for upper limb functional rehabilitation in stroke survivors. Anodal tDCS showed better clinical improvement compared to Cathodal tDCS.

Comparison of the surgical and post-operative outcomes between single incision laparoscopic appendicectomy (cross triangulation method) with normal conventional laparoscopic appendicectomy

Background: The usual multiport conventional laparoscopic surgeries (appendicectomy) are now being replaced by single incision laparoscopic surgeries (appendicectomy).In our study various aspects of SILS in comparison with the multiport conventional laparoscopic appendicectomy such as incision site pain, duration of surgery, morbidity and instruments used are discussed, duration of surgery, morbidity and instruments used are discussed.Methods: A single blinded randomized control trial was done on patients presenting with acute appendicitis. Pain numerical scale, use of analgesics, time to return to routine activities, hospital re-admission, complication like port site infection, hernia, intra operative complications rates, conversion rates and duration of surgery were evaluated. Various statistics of pain and other parameters are studied and evaluated. The mean operation time, mean recovery time, post-operative pain were statistically analysed using unpaired t-test. Results: Mean operating time was 44.16 minutes for SILS and 26.88 minutes for laparoscopic appendicectomy. The mean operative pain in scale of 1 to 4 was 1.40 and 0.40 for SILS and for laparoscopic appendicenctomy respectively making SILS more pain free and comfortable for the patient. The mean post-operative recovery time was 3.12 days for SILS and 7.88 days for laparoscopic appendicenctomy giving SILS patients more rapid recovery and resumption of work. Conclusions: SILS offers better cosmetic outcome, lesser post-operative pain and shorter duration of hospital stay compared to classical 3 port conventional laparoscopic surgery but at the expense of time. Operative difficulties along with time constraint need to be overcome by the surgeon.

Electromagnetic Navigated Versus Conventional Total Knee Arthroplasty—A Five-Year Follow-Up of a Single-Blind Randomized Control Trial

BackgroundThe objective of this study is to provide the 5-year follow-up results of a randomized study comparing conventional versus electromagnetic computer navigated total knee arthroplasty. MethodsAnalysis of 127 patients (66 navigated and 61 conventional surgeries) was performed from a prospective, single-blinded, randomized controlled trial. Patient-reported outcome measures were collected at 5 years after surgery and compared with previously published 1-year clinical outcomes. Five-year surgical revision rates were collated and compared between intervention groups. ResultsOverall, there have been continued improvements in the clinical scores of patients in both groups when compared with clinical data at 1 year; however, at 5 years, there is no statistical difference in any of the patient-reported outcome measures between conventional and navigated surgery. Interestingly, improved implant survivorship was observed in the navigated (0% revision rate) compared with the conventional group (4.9% all-cause revision rate). ConclusionElectromagnetic computer navigated technology produces similar clinical outcomes compared with traditional surgery. Further work is required to monitor implant survivorship, and clinical outcomes with long-term follow-up, to determine the cost effectiveness of this technology.

Effects of IV Magnesium Sulphate on Hemodynamic Response To Pneumoperitoneum In Laparoscopic Cholecyctectomy; A Randomized Control Trial

Objective: To determine the effect of IV Magnesium sulphate (MgSO4) in attenuating the hemodynamic effects of pneumoperitoneum.&#x0D; Methodology: Our single blind randomized control trial (based on computer generated randomize allocation) was carried out at Holy Family Hospital and included 60 patients, not allergic to MgSO4 and belonging to the American Society of Anesthesiology (class 1 and 2. Patients were divided into two groups with Intervention group (M group) receiving 30 mg/kg of MgSO4 and the control group (C group) receiving a placebo. Hemodynamic parameters were then measured at different points of time during surgery. Data was collected and analyzed by using statistical package for the social sciences (SPSS) version 25.0.&#x0D; Results: Out of 60 patients selected 86.7% were females while 13.3% were males. Mean age was 35.78(SD=8.26). As compared to group, patients belonging to group had significantly lower heart rate, systolic and diastolic blood pressure at 15 minutes, after release of pneumoperitoneum and at extubation with p values less than 0.05.&#x0D; Conclusion: Our study concludes that 30 mg/kg of MgSO4 given as a bolus just before creation of pneumoperitoneum protect against its possible adverse hemodynamic effects.

Effectiveness of biofeedback relaxation and audio-visual distraction on dental anxiety among 7- to 12-year-old children while administering local anaesthesia: A randomized clinical trial.

Local anaesthesia (LA) administration provokes dental anxiety in children. BrightHearts is a biofeedback relaxation application designed to reduce anxiety in children during painful procedural interventions. To compare the effectiveness of biofeedback relaxation (BR) and audio-visual (AV) distraction on dental anxiety among 7- to 12-year-old children while administering LA. A total of 70 children requiring dental treatment under LA for three visits were recruited for this single-blinded randomized control trial. They were randomly divided into two equal groups. Group A received BR and Group B received AV distraction during LA delivery in the first two visits, and both groups did not receive any intervention during LA in third visit. Outcomes were measured using heart rate and a cartoon-based anxiety measuring scale (Chotta Bheem-Chutki (CBC) scale). AV group had statistically significant higher mean heart rates than BR group (P<.001) during needle penetration and post-intervention, respectively. CBC scale showed no statistical differences between the groups. Both the interventions are effective in reducing dental anxiety during LA administration. Based on objective measures, BR is found to be better than AV distraction. Subjective scores, however, show no differences between the two.

A Direct-to-Public Peer Support Program (Big White Wall) Versus Web-Based Information to Aid the Self-management of Depression and Anxiety: Results and Challenges of an Automated Randomized Controlled Trial

BackgroundEffective help for depression and anxiety reaches a small proportion of people who might benefit from it. The scale of the problem suggests the need for effective, safe web-based public health services delivered directly to the public. One model, the Big White Wall (BWW), offers peer support at low cost. As these interventions are delivered digitally, we tested whether a randomized controlled trial (RCT) intervention could also be fully delivered and evaluated digitally.ObjectiveThis study aims to determine the reach, feasibility, acceptability, baseline costs, and outcomes of a public health campaign for an automated RCT of the BWW, providing digital peer support and information, compared with a standard website used by the National Health Service Moodzone (MZ), to people with probable mild-to-moderate depression and anxiety disorder. The primary outcome was the change in self-rated well-being at 6 weeks, measured using the Warwick-Edinburgh Mental Well-Being Scale.MethodsAn 18-month campaign was conducted across Nottinghamshire, the United Kingdom (target population 914,000) to advertise the trial directly to the public through general marketing, web-based and social media sources, health services, other public services, and third-sector groups. The population reach of this campaign was examined by the number of people accessing the study website and self-registering to the study. A pragmatic, parallel-group, single-blind RCT was then conducted using a fully automated trial website in which eligible participants were randomized to receive either 6 months of access to BWW or signposted to MZ. Those eligible for participation were aged >16 years with probable mild-to-moderate depression or anxiety disorders.ResultsOf 6483 visitors to the study website, 1510 (23.29%) were eligible. Overall, 790 of 1510 (52.32%) visitors participated. Of 790 visitors, 397 (50.3%) were randomized to BWW and 393 (49.7%) to MZ. Their mean age was 38 (SD 13.8) years, 81.0% (640/790) were female, 93.4% (738/790) were White, and 47.4% (271/572) had no contact with health services in the previous 3 months. We estimated 3-month productivity losses of £1001.01 (95% CI 868.75-1133.27; US $1380.79; 95% CI 1198.35-1563.23) per person for those employed. Only 16.6% (131/790) participants completed the primary outcome assessment. There were no differences in the primary or secondary outcomes between the 2 groups.ConclusionsMost participants reached and those eligible for this trial of digital interventions were White women not in recent contact with health services and whose productivity losses represent a significant annual societal burden. A fully automated RCT recruiting directly from the public failed to recruit and retain sufficient participants to test the clinical effectiveness of this digital intervention, primarily because it did not personally engage participants and explain how these unfamiliar interventions might benefit them.Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN) 12673428; https://www.isrctn.com/ISRCTN12673428International Registered Report Identifier (IRRID)RR2-10.2196/resprot.8061

English

BACKGROUND Managing pain and stress during and after any surgical procedure is a real challenge and a matter of concern for both surgeons and anaesthesiologists. Various analgesics like tramadol and nalbuphine have been used as adjuncts to anaesthetic agents with different efficacy. We wanted to do a comparative assessment of efficacy between intravenous (IV) administration of tramadol and nalbuphine in managing perioperative pain and stress. METHODS This was a single blinded randomised control trial, which included 60 female adult patients in the age group of 30 - 50 years who were posted for surgical procedures like elective vaginal hysterectomy under spinal block. Patients with comorbidities like diabetes, obesity, hypertension, impaired pulmonary function, recent history of medication with selective serotonin reuptake inhibitors were excluded from the study. Study participants were divided into two groups - group tramadol (TR) and group nalbuphine (NA) with 30 patients in each group. Group TR was given tramadol 0.5 - 0.7 mg / Kg whereas group NA was given nalbuphine 0.1 - 0.2 mg / Kg after an hour of spinal block. Both drugs were administered intravenously. Midazolam 0.01 - 0.05 mg / Kg was administered intravenously within first hour of surgery for sedation. Pain, stress and sedation score, requirement of rescue analgesics and occurrence of adverse drug reactions (ADRs) over 12 hours postoperatively were compared. RESULTS Significant lowering of pain and stress scores and higher sedation score was observed in group NA in comparison to group TR. The requirement of rescue analgesic and occurrence of side effects like nausea and vomiting were less in group NA. CONCLUSIONS Intravenous administration of nalbuphine was found to be more effective in perioperative control of pain and stress and can be a better choice than intravenous tramadol. KEYWORDS Efficacy, Tramadol, Nalbuphine, Rescue Analgesia

The effects of a static exercise programme versus Swiss ball training for core muscles of the lower back and pelvic region in patients with low back pain after child delivery. A single blind randomized control trial.

To determine the effects of static exercise programme compared to Swiss ball training for core muscles of the lower back and pelvic region in patients with low back pain after child delivery. The prospective single-blind randomised controlled trial was conducted at Rehabilitation department of Pakistan Railway General Hospital Rawalpindi from March to December 2018, and comprised patients with low back pain after delivery who were randomised into 2 equal groups. The subjects in Group A received static core exercises, while those in Group B got Swiss ball training. Outcome was measured using numeric pain rating scale, Oswestry disability index, goniometry and core stability assessment scale. Data was analysed using SPSS 21. Of the 30 patients, 15(50%) were in Group A with mean age of 28.38±4.8 years, and 15(50%) were in Group B with a mean age of 29.57±3.3 years. Intra-group difference was significant (p<0.05), while inter-group difference was non-significant (p>0.05). Both exercise protocols used in the study were equally effective in the rehabilitation of postpartum low back pain.

The Effects of Bicycle Simulator Training on Anticipatory and Compensatory Postural Control in Older Adults: Study Protocol for a Single-Blind Randomized Controlled Trial.

Background: Falls are the leading cause of fatal and non-fatal injuries among older adults. Perturbation-Based-Balance Training (PBBT) is a promising approach to reduce fall rates by improving reactive balance responses. PBBT programs are designed for older adults who are able to stand and walk on a motorized treadmill independently. However, frail older adults, whose fall rates are higher, may not have this ability and they cannot participate. Thus, there is a critical need for innovative perturbation exercise programs to improve reactive balance and reduce the fall risks among older adults in a wider range of functioning. Trunk and arms are highly involved in reactive balance reactions. We aim to investigate whether an alternative PBBT program that provides perturbations during hands-free bicycling in a sitting position, geared to improve trunk and arm reactive responses, can be transferred to reduce fall risks and improve balance function among pre-frail older adults.Methods: In a single-blinded randomized-controlled trial, 68 community-dwelling pre-frail older adults are randomly allocated into two intervention groups. The experimental group receives 24-PBBT sessions over 12-weeks that include self-induced internal and machine-induced external unannounced perturbations of balance during hands-free pedaling on a bicycle-simulator system, in combination with cognitive dual-tasks. The control group receives 24 pedaling sessions over 12-weeks by the same bicycle-simulator system under the same cognitive dual-tasks, but without balance perturbations. Participants' reactive and proactive balance functions and gait function are assessed before and after the 12-week intervention period (e.g., balance reactive responses and strategies, voluntary step execution test, postural stability in upright standing, Berg Balance Test, Six-meter walk test, as well as late life function and fear of falling questionnaires).Discussion: This research addresses two key issues in relation to balance re-training: (1) generalization of balance skills acquired through exposure to postural perturbations in a sitting position investigating the ability of pre-frail older adults to improve reactive and proactive balance responses in standing and walking, and (2) the individualization of perturbation training to older adults' neuromotor capacities in order to optimize training responses and their applicability to real-life challenges.Clinical Trial Registration: www.clinicaltrials.gov, NCT03636672 / BARZI0104; Registered: July 22, 2018; Enrolment of the first participant March: 1, 2019. See Supplementary File.

The effect of intraoperative autofluorescence monitoring on unintentional parathyroid gland excision rates and postoperative PTH concentrations-a single-blind randomized-controlled trial.

Intraoperative imaging of parathyroid glands (PGs) has been developed in order to reduce the risk of unintentional parathyroidectomy during total thyroidectomy. This novel modality is based on their intrinsic characteristic of autofluorescence (AF) after near-infrared light exposure. The aim of this study was to assess the effect of this method on the risk of unintentional PG excision (total or partial) during total thyroidectomy. This was a single-blind, randomized-controlled trial including adult patients who underwent scheduled total thyroidectomy between December 2019 and March 2020. These patients were randomly allocated to two groups: one in which near-infrared autofluorescence imaging (NIRAF) was applied (NIR group) and one without NIRAF (NONIR group). Hormonal and biochemical assessment was performed pre- and 24-h postoperatively. AF findings and the number of PGs autotransplanted were recorded. One-hundred and eighty patients were eligible. Unintentional (total or partial) PG excision rates during total thyroidectomy in the NONIR (n = 90) and NIR (n = 90) groups were 28.9% [95% confidence interval (CI) 19.8-39.4%] and 14.4% (95% CI 7.7-22.1%), respectively (p = 0.02). Furthermore, NIR reduced the risk of parathyroid tissue presence in the specimen sent for pathology (relative risk 0.51, 95% CI 0.28-0.92; p = 0.02). However, the number of PGs identified by NIR could not predict the risk of postoperative hypoparthyroidism. NIRAF imaging during total thyroidectomy led to a significant reduction in PG excision rates. However, this modality did not result in the reduction of postoperative hypoparathyroidism or hypocalcemia risk.

Live Video Adaptations to a Mind-Body Activity Program for Chronic Pain and Cognitive Decline: Protocol for the Virtual Active Brains Study.

BackgroundChronic pain (CP) and cognitive decline (CD) are costly, challenging to treat, prevalent among older adults, and worsen each other over time. We are iteratively developing Active Brains-Fitbit (AB-F), a live video program for older adults with CP and CD that teaches mind-body skills and gradual increases in step count. AB-F has demonstrated feasibility; acceptability; and signs of improvement in emotional, physical, and cognitive functions when delivered in person to older adults.ObjectiveWe are conducting a feasibility randomized controlled trial (RCT) of AB-F versus a time- and dose-matched educational control (health enhancement program [HEP]) in older adults with CP and CD. Here, we describe virtual adaptions to our study protocol, manualized treatments, evaluation plan, and study design in response to feedback from former participants and COVID-19. We will evaluate the feasibility benchmarks and the potential of AB-F to improve physical, emotional, and cognitive functions.MethodsThis is a single-blind pilot RCT. Participants are randomized to AB-F or HEP. Patients are recruited through pain clinic referrals, institutional registries, and flyers. Interested participants are screened for eligibility via telephone and provide electronic informed consent. After randomization, participants are mailed all study documents, including their treatment manual, an ActiGraph accelerometer, and a Fitbit (separate envelope for AB-F only). Both conditions are manualized and delivered over 8 weekly sessions via Zoom. Participants complete self-report and performance-based (6-min walk test and Montreal Cognitive Assessment) outcome measures via Zoom at baseline and post intervention. Primary outcomes are a priori set feasibility (recruitment, quantitative measures, and adherence), acceptability, credibility, expectancy, and satisfaction benchmarks. Secondary outcomes are physical, cognitive, and emotional functions as well as intervention targets (social function, pain intensity, pain-specific coping, and mindfulness).ResultsThe trial is ongoing. We have recruited 21 participants (10 AB-F and 11 HEP) across 2 rounds. Only 2 participants have withdrawn (1 before baseline and 1 before the first session). All 19 remaining participants have completed the baseline assessment. In the first round, attendance is high (11 out of 12 participants completed all 4 sessions so far), and AB-F participants are adherent to their Fitbit and step goals (5 out of 6 participants).ConclusionsPreliminary findings are promising for the feasibility of our completely virtual AB-F intervention. However, these findings need to be confirmed at the trial conclusion. This study will answer important questions about the feasibility of delivering a completely virtual mind-body activity program to older adults with comorbid CP and CD, which, to our knowledge, is unprecedented. Details on integrating multiple digital platforms for virtual assessments and intervention delivery will inform treatment development for older adults and those with comorbid CP and CD, which is crucial during the COVID-19 pandemic.Trial RegistrationClinicalTrials.gov NCT04044183; https://clinicaltrials.gov/ct2/show/NCT04044183International Registered Report Identifier (IRRID)DERR1-10.2196/25351

Efficacy of blink software in improving the blink rate and dry eye symptoms in visual display terminal users - A single-blinded randomized control trial.

Purpose:Dry eye disease (DED) is a multifactorial disease, more prevalent among visual display terminal users. Reduced blink rate is a risk factor to dry eye disorder, innovative means to remind to blink while using computers can be helpful.Methods:Single-blinded Randomized Control Trial enrolled computer users with dry eye. Allocation concealment was done using opaque envelope and principal investigator was blinded. After baseline examination, eligible participants were randomized to intervention group (appearance of bars is 8 times/min) and control group (appearance of bars is 1 time/min). Participants from both groups used the software for 15 days, came for first follow up, and did not use the software for next 15 days until second follow-up examination. During each visit, detailed eye examination was done including blink rate, tear film break up time, and Ocular Surface Disease Index score.Results:Forty-six participants (women n = 31; men n = 15) with a mean age of 28.02 (±6.295) years completed the study. Four participants were excluded from analysis because of early dropout. In the intervention group (n = 23) and control group (n = 23), participants were allocated. At the end of first phase, there was statistically significant difference in OSDI score (P = 0.021). Statistically significant difference was noticed in OSDI (P = 0.014) and blink rate (P = 0.049) as baseline, and final visit data were compared.Conclusion:“Blink–Blink” software with 8 reminders/min improved DED-related symptoms by increasing the blink rate. The carry-over effect after cessation of Blink-Blink software in improving blink rate was maintained even after 1 month.Trial Registration: Clinical Trials Registry-India (CTRI): CTRI/2018/08/015176