The effect of eye movement desensitization and reprocessing (EMDR) on abdominal pain in patients with irritable bowel syndrome (IBS): a study protocol for a randomized controlled trial (EMDR4IBS)
This study is a randomized controlled trial which will be conducted at a city hospital in the Netherlands. Adult patients with considerable IBS pain (pain intensity at least 60/100 during at least 5/10  days) will be randomly assigned to either EMDR therapy or the wait list. We aim to include 34 participants. The EMDR condition comprises seven sessions, around 90 min in length delivered weekly, the first of which is a case conceptualization session. All participants will be assessed at baseline, post-treatment, and at 3 months follow-up. The primary outcome measure is pain intensity on a Likert scale which is self-repor...
Source: Trials - December 4, 2023 Category: Research Source Type: clinical trials

The effect of switch therapy to tenofovir versus entecavir maintenance on recurrence of hepatocellular carcinoma after surgery (SWITE): study protocol for a randomized controlled trial
AbstractBackgroundAntiviral therapy has been reported to be associated with lower recurrence rate of hepatocellular carcinoma (HCC) for patients with hepatitis B virus (HBV) infection. While entecavir (ETV) and tenofovir disoproxil fumarate (TDF) were both recommended as first-line therapies for HBV patients, recent retrospective studies proposed a lower incidence rate of HCC occurrence or recurrence in those receiving TDF compared ETV. However, the survival benefits of switching to TDF therapy after prolonged ETV treatment before surgery remain uncertain. We delineate the rationale and design of SWITE, a randomized, open-...
Source: Trials - December 2, 2023 Category: Research Source Type: clinical trials

Factors influencing the time to ethics and governance approvals for clinical trials: a retrospective cross-sectional survey
AbstractBackgroundThe findings from multi-centre trials are central to the practice of evidence-based medicine, enabling the development and implementation of new treatments. The time it takes to commence clinical trials at sites can be long, and ethics and governance approvals are key steps on the pathway to site activation. The goal of this study was to explore factors influencing the times to ethics approval, governance approval and site activation for multi-centre clinical trials.MethodsThis paper assessed the associations of trial characteristics (disease area and trial phase), site characteristics (government or priv...
Source: Trials - December 1, 2023 Category: Research Source Type: clinical trials

Effects of exercise prehabilitation before anterior cruciate ligament reconstruction on functional outcomes during pre- and postoperative rehabilitation — protocol for a single-blinded randomised controlled trial
DiscussionThe planned study targets to fill a gap in the evidence regarding effective designs of prehabilitation training before surgical ACL reconstruction. Potential difficulties that could affect the conduct of the study are lack of treatment adherence of the patients and high dropout.Trial registrationGerman Register of Clinical Trials DRKS-ID:DRKS00030312. Registered on 26 September 2022. (Source: Trials)
Source: Trials - November 24, 2023 Category: Research Source Type: clinical trials

Effectiveness and cost-effectiveness of an electronic mindfulness-based intervention to improve maternal mental health in the peripartum: study protocol for a randomised controlled trial
This study was approved by the Mater Misericordiae Human Research Ethics Committee (83,589). Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12622001581752 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385107&isReview=true). Registered on 22 Dec. 2022. (Source: Trials)
Source: Trials - November 23, 2023 Category: Research Source Type: clinical trials

Multisensory stimulation bundles on sleep and neurobehavioral development in the first year after birth in very preterm infants: a randomized crossover controlled study protocol
This study presents a protocol for an evaluator-blinded, randomized crossover trial. It aims to assess the sleep efficiency of hospitalized VPIs by providing multisensory stimulation bundles. Furthermore, it aims to observe the intervention impacts on sleep during hospitalization of the VPIs and their sleep and neurodevelopmental outcomes during the first year of post-discharge follow-up.MethodsThe study will be conducted in the neonatology department of a tertiary pediatric teaching hospital. All the eligible VPIs will undergo two types of care in random order: “standard care” (2 weeks) and “standard care plus multi...
Source: Trials - November 15, 2023 Category: Research Source Type: clinical trials

PROMISE: effect of protein supplementation on fat-free mass preservation after bariatric surgery, a randomized double-blind placebo-controlled trial
AbstractIntroductionProtein malnutrition after bariatric surgery is a severe complication and leads to significant morbidity. Previous studies have shown that protein intake and physical activity are the most important factors in the preservation of fat-free mass during weight loss. Low protein intake is very common in patients undergoing bariatric surgery despite dietary counseling. Protein powder supplements might help patients to achieve the protein intake recommendations after bariatric surgery and could therefore contribute to preserve fat-free mass. This double-blind randomized placebo-controlled intervention study a...
Source: Trials - November 9, 2023 Category: Research Source Type: clinical trials

Social Emotional and Ethical Development (SEED)
Conditions: Development, Child; Mindfulness; Mental Well-being Interventions: Behavioral: Social, Emotional, and Ethical Development (SEED) curriculum Sponsors: Chinese University of Hong Kong Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - November 8, 2023 Category: Research Source Type: clinical trials

Innovative and disruptive technologies to prescribe, encourage, and evaluate physical exercise in healthy adults: a protocol of exploratory study followed by a noninferiority, investigator-blinded randomized clinical trial
DiscussionAnticipated outcomes include improved exercise adherence through the gamified application, better maintenance of prescribed exercise intensity, and enhanced health biomarkers. The results of this study will inform health-related decision-making.Trial registrationThe study protocol received approval from the Ethics Committee of Universidade Federal de Ci ências da Saúde de Porto Alegre (54,492,221.80000.5345) and has been registered with the Brazilian Registry of Clinical Trials (ReBEC, RBR-359p69v). (Source: Trials)
Source: Trials - October 30, 2023 Category: Research Source Type: clinical trials

The effects of intermittent fasting diet alone or in combination with probiotic supplementation in comparison with calorie-restricted diet on metabolic and hormonal profile in patients with polycystic ovary syndrome: study protocol for a randomized clinical trial
DiscussionWe hypothesized that 10-h TRE administered alone or in combination with probiotic supplementation to overweight and obese PCOS subjects would lead to weight loss and improved metabolic, hormonal, inflammatory, and antioxidant markers compared to control subjects following a standard 3-meal-per-day CR diet.Ethical aspectsThe current trial received approval from the Medical Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran (IR.TUMS.MEDICNE.REC.1401.425).Trial registrationIranian Registry of Clinical Trials IRCT20121110011421N5. Registered on 3 October 2022. (Source: Trials)
Source: Trials - October 25, 2023 Category: Research Source Type: clinical trials

Bad research is not all bad
AbstractIn this commentary, we discuss a recent article inTrials that raised concerns about the number of poorly performed randomised trials in the medical literature and discuss the trials literature more widely. Although we all aim for higher methodological standards in trials, we argue that (i) the idea that ‘most randomised trials are bad’, which the recent article concludes is an overly simplistic representation of the situation, and (ii) the suggestion that an increased focus on methodological review during trial development (e.g. ethical boards performing some assessment of the methodologists on a trial), while ...
Source: Trials - October 20, 2023 Category: Research Source Type: clinical trials

Response to Merz
AbstractJon Merz raises two objections to our article on the ethics of behavioral influences in trial recruitment. In this response, we defend our article against these objections. We argue that Merz ’s critique rests on a misunderstanding of our article, defend the daily life standard as a guardrail for leveraging cognitive biases, and argue that rejecting all behavioral influences is not a helpful nor a sustainable answer to their increasing use in trial recruitment. (Source: Trials)
Source: Trials - October 6, 2023 Category: Research Source Type: clinical trials

Use of Stratafix Symmetric ™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery
Conditions: C.Surgical Procedure; Disruption of Wound, Suture Interventions: Device: Stratafix suture; Device: Standard of care suture Sponsors: West Michigan Cancer Center; Ethicon, Inc. Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - October 2, 2023 Category: Research Source Type: clinical trials

Dual tracer navigation for lymph node dissection in laparoscopic radical gastrectomy (DANCE trial): a protocol for a prospective, randomized clinical trial
This study will investigate the efficacy and safety of a novel strategy using dual tracers for laparoscopic gastrectomy. The protocol has been approved by the Ethics Committee of Nanjing Drum Tower Hospital (2021-361-02). The trial findings will be published in peer-reviewed journals.Trial registrationChinese Clinical Trial Registry (ChiCTR2100051309). Registered 18 September 2021,https://www.chictr.org.cn/showproj.html?proj=133764. (Source: Trials)
Source: Trials - October 2, 2023 Category: Research Source Type: clinical trials

The antidepressant effect of intermittent theta burst stimulation (iTBS): study protocol for a randomized double-blind sham-controlled trial
DiscussionThe aims of the present trial are to investigate the antidepressive effect of a 10-session iTBS protocol on moderately depressed outpatients and to explore the factors that can explain the reduction in depressive symptoms after iTBS but also a poorer response to the treatment. In separate, but related work packages, the trial will assess how clinical, cognitive, brain imaging and genetic measures at baseline relate to the variability in the antidepressive effects of iTBS.Trial registrationClinicalTrials.gov NCT05516095. Retrospectively registered on August 25, 2022. (Source: Trials)
Source: Trials - October 2, 2023 Category: Research Source Type: clinical trials