Does somatosensory discrimination therapy alter sensorimotor upper limb function differently compared to motor therapy in children and adolescents with unilateral cerebral palsy: study protocol for a randomized controlled trial
DiscussionThis protocol describes the design of an RCT comparing the effectiveness of somatosensory discrimination therapy and dose-matched motor therapy to improve sensorimotor upper limb function in children and adolescents with uCP. The results of this study may aid in the selection of the most effective upper limb therapy, specifically for children and adolescents with tactile impairments.Trial registrationClinicalTrials.gov (NCT06006065). Registered on August 8, 2023. (Source: Trials)
Source: Trials - February 26, 2024 Category: Research Source Type: clinical trials
Comparing the effects of pulsed and radiofrequency catheter ablation on quality of life, anxiety, and depression of patients with paroxysmal supraventricular tachycardia: a single-center, randomized, single-blind, standard-controlled trial
Radiofrequency catheter ablation (RFCA) may lead to decreased quality of life (QOL) and increased anxiety and depression in patients with paroxysmal supraventricular tachycardia (PSVT), possibly due to the lac... (Source: Trials)
Source: Trials - February 24, 2024 Category: General Medicine Authors: Ying Du, Shanshan Ma, Pan Yue, Ying Xu, Ya Wen, Mingzhu Ji, Lingxiao He and Dengbin Liao Tags: Research Source Type: research
Comparing the effects of pulsed and radiofrequency catheter ablation on quality of life, anxiety, and depression of patients with paroxysmal supraventricular tachycardia: a single-center, randomized, single-blind, standard-controlled trial
ConclusionsOur study provided new and meaningful evidence that PFA was effective in significantly improving QOL and decreasing anxiety and depression in PFA patients.Trial registrationChinese Clinical Trial Registry, ChiCTR2200060272. (Source: Trials)
Source: Trials - February 24, 2024 Category: Research Source Type: clinical trials
Trial protocol for the Building Resilience through Socio-Emotional Training (ReSET) programme: a cluster randomised controlled trial of a new transdiagnostic preventative intervention for adolescents
Adolescence is a period of heightened vulnerability to developing mental health problems, and rates of mental health disorder in this age group have increased in the last decade. Preventing mental health probl... (Source: Trials)
Source: Trials - February 23, 2024 Category: General Medicine Authors: Essi Viding, Alex Lloyd, Roslyn Law, Peter Martin, Laura Lucas, Tom Chin-Han Wu, Nikolaus Steinbeis, Nick Midgley, Ren é Veenstra, Jaime Smith, Lili Ly, Geoffrey Bird, Jennifer Murphy, David Plans, Marcus Munafo, Ian Penton-Voak & hellip; Tags: Study protocol Source Type: research
The effect of a cognitive training therapy based on stimulation of brain oscillations in patients with mild cognitive impairment in a Chilean sample: study protocol for a phase IIb, 2 × 3 mixed factorial, double-blind randomised controlled trial
The ageing population has increased the prevalence of disabling and high-cost diseases, such as dementia and mild cognitive impairment (MCI). The latter can be considered a prodromal phase of some dementias an... (Source: Trials)
Source: Trials - February 23, 2024 Category: General Medicine Authors: Alejandra Figueroa-Vargas, Bego ña Góngora, María Francisca Alonso, Alonso Ortega, Patricio Soto-Fernández, Lucía Z-Rivera, Sebastián Ramírez, Francisca González, Paula Muñoz Venturelli and Pablo Billeke Tags: Study protocol Source Type: research
PAIN2.0: study protocol for a multicentre randomised controlled trial to evaluate the efficacy of a 10-week outpatient interdisciplinary multimodal pain therapy to manage recurrent pain for patients with risk factors of developing chronic pain in Germany
Up to 27% of the German population suffers from recurrent or persistent pain (lasting more than three months). Therefore, prevention of chronic pain is one major object of pain management interventions. The ai... (Source: Trials)
Source: Trials - February 23, 2024 Category: General Medicine Authors: Sandra Meyer-Moock, Daniel Szczotkowski, Leonie Schouten, Frank Petzke, Lena Milch, Beatrice Metz-Oster, Louise Zinndorf, Christian Geber, Greta Hoffmann, Anke Prei ßler, Ursula Marschall, Felix Rottke, Anja Waidner, André Möller, Thomas Isenberg, Gabr Tags: Study protocol Source Type: research
PAIN2.0: study protocol for a multicentre randomised controlled trial to evaluate the efficacy of a 10-week outpatient interdisciplinary multimodal pain therapy to manage recurrent pain for patients with risk factors of developing chronic pain in Germany
DiscussionRecurrent or persistent pain is common in the German population and causes high costs for patients and society. The A-IMPT aims to improve pain and pain-related impairments in pain patients at risk of chronification, thereby reducing the risk of developing chronic pain with its high socioeconomic burden. This new therapy could easily be integrated into existing therapy programs if positively evaluated.Trial registrationThe trial PAIN2.0 has been registered in the German Clinical Trials Register (DRKS) since 21/11/2022 with the IDDRKS00030773. (Source: Trials)
Source: Trials - February 23, 2024 Category: Research Source Type: clinical trials
The effect of a cognitive training therapy based on stimulation of brain oscillations in patients with mild cognitive impairment in a Chilean sample: study protocol for a phase IIb, 2 × 3 mixed factorial, double-blind randomised controlled trial
This study is a phase IIb randomised, double-blind clinical trial with a 3-month follow-up period. The study participants will be 62 participants diagnosed with MCI, aged over 60, from Valpara íso, Chile. Participants will receive an intervention combining twelve cognitive training sessions with tACS. Participants will receive either tACS or placebo stimulation in eight out of twelve training sessions. Sessions will occur twice weekly over 6 weeks. The primary outcomes will be electroen cephalographic measurements through the prefrontal theta oscillatory activity, while the secondary effects will be cognitive assessments...
Source: Trials - February 23, 2024 Category: Research Source Type: clinical trials
Trial protocol for the Building Resilience through Socio-Emotional Training (ReSET) programme: a cluster randomised controlled trial of a new transdiagnostic preventative intervention for adolescents
DiscussionThis project adopts a theory-based approach to the development of a new intervention designed to target the close connections between young people ’s emotions and their interpersonal relationships. By embedding the intervention within a school setting and using a cluster-randomised design, we aim to develop and test a feasible, scalable intervention to prevent the onset of psychopathology in adolescence.Trial registrationISRCTN88585916. Trial registration date: 20/04/2023. (Source: Trials)
Source: Trials - February 23, 2024 Category: Research Source Type: clinical trials
Statistical analysis plan for the phaco TIp position during clear corneal Phacoemulsification Surgery (TIPS) randomized controlled trial
Cornea is the most important refractive media in the eye, and damage to the corneal endothelium is one of the most common causes of poor visual outcome following cataract surgery, particularly in those with pr... (Source: Trials)
Source: Trials - February 22, 2024 Category: General Medicine Authors: Soujanya Kaup, Dimple Kondal, Siddharudha Shivalli and John Buchan Tags: Update Source Type: research
Understanding implementation of findings from trial method research: a mixed methods study applying implementation frameworks and behaviour change models
Trial method research produces recommendations on how to best conduct trials. However, findings are not routinely implemented into practice. To better understand why, we conducted a mixed method study on the c... (Source: Trials)
Source: Trials - February 22, 2024 Category: General Medicine Authors: Taylor Coffey, Paula R. Williamson and Katie Gillies Tags: Research Source Type: research
Comparison of 2D 4K vs. 3D HD laparoscopic imaging systems in bariatric surgery: study protocol for a randomized controlled prospective trial
Vision is an important and defining element of laparoscopy and significantly affects the outcome of surgery in terms of time, error, and precision. Several new imaging systems have become available for laparos... (Source: Trials)
Source: Trials - February 22, 2024 Category: General Medicine Authors: Tibor A. Zwimpfer, Nadja Stiegeler, Philip C. M üller, Andreas Schötzau, Bernhard Fellmann-Fischer, Viola Heinzelmann-Schwarz, Ralph Peterli and Marko Kraljević Tags: Study protocol Source Type: research
Seroma control in axillary lymphadenectomy with Glubran 2 ® without drain. Multicenter, prospective, randomized, clinical trial. GALA-ND study (Glubran, Axillary Lymphadenectomy, Ambulatory, No Drain)
Seroma after breast cancer surgery is a frequent entity; therefore, different products have been described in literature with the aim to reduce it. The most studied ones have been the sealants products, being ... (Source: Trials)
Source: Trials - February 22, 2024 Category: General Medicine Authors: Sandra L ópez Gordo, Neus Ruiz-Edo, Maria Teresa Fernández-Planas, Sara Viscaya-Martín and Cristina Serra-Serra Tags: Study protocol Source Type: research
Evaluation of intensive community care services for young people with psychiatric emergencies: study protocol for a multi-centre parallel-group, single-blinded randomized controlled trial with an internal pilot phase
This study aims to evaluate the clinical effectiveness and cost-effectiveness of intensive community care service (ICCS) compared to treatment as usual (TAU) for young people with psychiatric emergencies.MethodsThis is a multicentre two-arm randomized controlled trial (RCT) with an internal pilot phase. Young people aged 12 to< 18 considered for admission at participating NHS organizations across the UK will be randomized 1:1 to either TAU or ICCS. The primary outcome is the time to return to or start education, employment, or training (EET) at 6 months post-randomization. Secondary outcomes will include evaluations of ...
Source: Trials - February 22, 2024 Category: Research Source Type: clinical trials
Comparison of 2D 4K vs. 3D HD laparoscopic imaging systems in bariatric surgery: study protocol for a randomized controlled prospective trial
The objective is to provide clinical evidence for new laparoscopic imaging systems and to evaluate potential benefits.Trial registrationThis trial is registered at clinicaltrials.gov under the identifier NCT05895058. Registered 30 May 2023. BASEC2023-D0014 [Registry ID Swissethics, approved 3 May 2023]. SNCTP000005489 [SNCTP study register, last updated 13 July 2023]. (Source: Trials)
Source: Trials - February 22, 2024 Category: Research Source Type: clinical trials
