Search results for "Randomised controlled trial"

Group Music Therapy as a Preventive Intervention for Young People at Risk : Cluster-Randomized Trial

2017

Background Music forms an important part of the lives and identities of adolescents and may have positive or negative mental health implications. Music therapy can be effective for mental disorders such as depression, but its preventive potential is unknown. Objective The aim of this study was to examine whether group music therapy (GMT) is an effective intervention for young people who may be at risk of developing mental health problems, as indicated via unhealthy music use. The main question was whether GMT can reduce unhealthy uses of music and increase potentials for healthy uses of music, compared to self-directed music listening (SDML). We were also interested in effects of GMT on dep…

Dexketoprofen/tramadol: randomised double-blind trial and confirmation of empirical theory of combination analgesics in acute pain

2015

Background Combination analgesics are effective in acute pain, and a theoretical framework predicts efficacy for combinations. The combination of dexketoprofen and tramadol is untested, but predicted to be highly effective. Methods This was a randomised, double-blind, double-dummy, parallel-group, placebo-controlled, single-dose trial in patients with moderate or severe pain following third molar extraction. There were ten treatment arms, including dexketoprofen trometamol (12.5 mg and 25 mg) and tramadol hydrochloride (37.5 mg and 75 mg), given as four different fixed combinations and single components, with ibuprofen 400 mg as active control as well as a placebo control. The study objecti…

Study protocol for a multi-component kindergarten-based intervention to promote healthy diets in toddlers: a cluster randomized trial

2016

Background: There is concern about the lack of diversity in children’s diets, particularly low intakes of fruit and vegetables and high intakes of unhealthy processed food. This may be a factor in the rising prevalence of obesity. A reason for the lack of diversity in children’s diets may be food neophobia. This study aimed to promote a healthy and varied diet among toddlers in kindergarten. The primary objectives were to reduce food neophobia in toddlers, and promote healthy feeding practices among kindergarten staff and parents. Secondary objectives were to increase food variety in toddlers’ diets and reduce future overweight and obesity in these children. Methods: This is an ongoing, clu…

The effect of a school-based intervention on physical activity, cardiorespiratory fitness and muscle strength : the School in Motion cluster randomiz…

2020

Abstract Background Physical activity (PA) declines throughout adolescence, therefore PA promotion during this period is important. We analyzed the effect of two school-based PA interventions on daily PA levels, cardiorespiratory fitness (CRF) and muscle strength among adolescents. Methods For the nine-month School in Motion intervention study (ScIM), we cluster-randomized 30 Norwegian secondary schools (N = 2084, mean age [SD] = 14 [0.3] years) to one of three study arms. The physically active learning (PAL) intervention included 30 min physically active learning, 30 min PA and a 60 min physical education (PE) lesson per week. The Don’t worry-Be happy (DWBH) intervention included a 60 min …

Effectiveness of a Psychosocial Care Quality Improvement Strategy to Address Quality of Life in Patients with Cancer: The HuCare2 Stepped-Wedge Clust…

2021

Key Points Question Does an implementation strategy integrating psychosocial care into cancer centers improve at least 1 of 2 domains (emotional or social function) of health-related quality of life? Findings This stepped-wedge cluster randomized clinical trial included 762 patients with cancer at high risk for reduced quality of life. Health-related quality of life score improved from baseline to 3 months among participants in the Humanization in Cancer Care Quality Improvement Strategy arm vs the usual care arm, showing a statistically significant difference for emotional function, but not for social function. Meaning This study suggests the use of an implementation strategy aiming to pro…

Single-centre, triple-blinded, randomised, 1-year, parallel-group, superiority study to compare the effects of Roux-en-Y gastric bypass and sleeve ga…

2019

IntroductionBariatric surgery is increasingly recognised as an effective treatment option for subjects with type 2 diabetes and obesity; however, there is no conclusive evidence on the superiority of Roux-en-Y gastric bypass or sleeve gastrectomy. The Oseberg study was designed to compare the effects of gastric bypass and sleeve gastrectomy on remission of type 2 diabetes and β-cell function.Methods and analysisSingle-centre, randomised, triple-blinded, two-armed superiority trial carried out at the Morbid Obesity Centre at Vestfold Hospital Trust in Norway. Eligible patients with type 2 diabetes and obesity were randomly allocated in a 1:1 ratio to either gastric bypass or sleeve gastrecto…

Comparison of intramuscular and subcutaneous administration of a herpes zoster live-attenuated vaccine in adults aged ≥50 years: a randomised non-inf…

2015

AbstractZostavax® is a live, attenuated varicella zoster virus (VZV) vaccine developed specifically for the prevention of HZ and PHN in individuals aged ≥50 years. During the clinical development of Zostavax, which was mainly in the US, the vaccine was administrated by the subcutaneous (SC) route. In Europe, many healthcare professionals prefer administering vaccines by the intramuscular (IM) route. This was an open-label, randomised trial conducted in 354 subjects aged ≥50 years. The primary objectives were to demonstrate that IM administration is both non-inferior to SC administration in terms of 4-week post-vaccination geometric mean titres (GMTs), and elicits an acceptable geometric mea…

Clinic modelling randomised trials (CMRT's) in animals as a new intermediate between biological experiments and randomised clinical trials: applicati…

1998

A Multicentre, Randomised, Controlled Trial of a Combined Clinical Treatment for First-Episode Psychosis

2021

Introduction: There is evidence that early intervention contributes to improving the prognosis and course of first-episode psychosis (FEP). However, further randomised treatment clinical trials are needed. Objectives: The aim of this study was to compare the efficacy of a combined clinical treatment involving Cognitive Behavioural Therapy (CBT) as an adjunctive to treatment-as-usual (TAU) (CBT+TAU) versus TAU alone for FEP. Patients and methods: In this multicentre, single-blind, randomised controlled trial, 177 participants were randomly allocated to either CBT+TAU or TAU. The primary outcome was post-treatment patient functioning. Results: The CBT+TAU group showed a greater improvement in…

Ureteral Stones: Shockwave Lithotripsy or Ureteroscopy, Which is Best?

2021

Background Renal stone disease is common and can cause emergency presentation with acute pain due to ureteric colic. International guidelines have stated the need for a multicentre randomised controlled trial (RCT) to determine whether a non-invasive outpatient (shockwave lithotripsy [SWL]) or surgical (ureteroscopy [URS]) intervention should be the first-line treatment for those needing active intervention. This has implications for shaping clinical pathways. Objective To report a pragmatic multicentre non-inferiority RCT comparing SWL with URS. Design, setting, and participants This trial tested for non-inferiority of up to two sessions of SWL compared with URS as initial treatment for ur…