scholarly journals Efficacy of acupuncture in improving the symptoms and the quality of life of patients with moderate or severe acne vulgaris: study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Ruimin Jiao ◽  
Man Huang ◽  
Weina Zhang ◽  
Zhishun Liu
2021 ◽  
Vol 9 ◽  
Author(s):  
Covadonga M. Díaz-Caneja ◽  
Javier Martín-Babarro ◽  
Renzo Abregú-Crespo ◽  
Miguel Á. Huete-Diego ◽  
Marta Giménez-Dasí ◽  
...  

Introduction: Bullying is a major preventable risk factor for mental disorders. Available evidence suggests school-based interventions reduce bullying prevalence rates. This study aims to test the efficacy of a web-enabled, school-based, multicomponent anti-bullying intervention to prevent school bullying and to assess its effects on mental health and quality of life.Methods and analysis: Cluster randomized controlled trial conducted in 20 publicly funded primary and secondary schools in Madrid, Spain. Schools are randomly allocated to either the intervention arm (n = 10) or conventional practices arm (n = 10). The web-enabled intervention (LINKlusive) lasts ~12 weeks and consists of three main components: (i) an online training program for teachers and parents, (ii) a web-guided educational program for students, focusing on promoting respect for diversity, empathy, and social skill development, and (iii) a web-guided, teacher-delivered, targeted intervention program for bullying situations identified based on peer-support strategies and individual intervention for those involved (i.e., bullying victims and perpetrators). The primary objective is to compare differences between peer-reported bullying victimization in the intervention and control arms at the end of the intervention. Secondary outcome measures are additional measures of bullying victimization and perpetration, mental health symptoms, self-esteem, and quality of life. A follow-up assessment is conducted 1 year after the end of the intervention. Treatment effects will be tested using multilevel mixed models, adjusting for school-, classroom-, and student-related covariates. Considering the increased bullying rates in children with special educational needs, a specific subgroup analysis will test the efficacy of the intervention on bullying prevalence, mental health, and quality of life in this particularly vulnerable population.Ethics and Dissemination: The Deontology Commission of the School of Psychology, Universidad Complutense in Madrid, Spain reviewed the study protocol and granted ethical approval on 21st January 2019. The results of the trial will be disseminated in relevant peer-reviewed journals and at conferences in the field.Trial Registration Number: ISRCTN15719015.


Trials ◽  
2012 ◽  
Vol 13 (1) ◽  
Author(s):  
Paulo de Tarso Camillo de Carvalho ◽  
Ernesto Cesar Pinto Leal-Junior ◽  
Ana Carolina Araruna Alves ◽  
Caroline Sobral de Melo Rambo ◽  
Luciana Maria Malosa Sampaio ◽  
...  

2020 ◽  
Author(s):  
Ruimin Jiao ◽  
Man Huang ◽  
Weina Zhang ◽  
Zhishun Liu

Abstract Background : Acne vulgaris (AV) is a common chronic dermatologic disease that tends to impair the appearance and the quality of life (QoL) of patients. Although several trials have indicated the effectiveness of acupuncture for treatment of patients with AV, the results of these trials have been contested owing to potential bias in their design. Thus, there is a lack of robust data to evaluate the efficacy of acupuncture in patients with AV. In addition, none of the previous clinical trials of acupuncture therapy for AV used QoL as a primary outcome or employed a sham acupuncture control arm. The aim of the study is to evaluate the effect of acupuncture on the symptoms and the QoL of patients with moderate or severe AV. Methods/design: One hundred eligible participants with AV will be randomly assigned to acupuncture or sham acupuncture groups (1:1 allocation). All participants will receive 4-week treatment comprising of a total of 12 sessions (3 sessions per week). The primary outcome will be change from baseline in the Skindex-16 scale total score at treatment completion. The secondary outcomes will be: Skindex-16 subscale score; the Dermatology Life Quality Index scale total score; the total lesion count and inflammatory lesion count; visual analogue scale scores for assessment of itch and pain; patient expectations of acupuncture; and the blinding of the effect of sham acupuncture. Follow-up evaluation will be performed at weeks 16 and 28. All outcome analyses will be performed in the intention-to-treat population. Discussion: We expect to evaluate the effectiveness of acupuncture in ameliorating the symptoms and improving the QoL of patients with moderate or severe AV compared with sham acupuncture with more robust evidence. The limitations of the trial design are its single center scope, relatively small sample size, and lack of blinding of the acupuncturists. Trial Registration: Chinese Clinical Trial Registry, ChiCTR-1900023649 (Date of registration: Jan 2, 2019). Keywords: acupuncture, acne vulgaris, quality of life, randomized-controlled trial, protocol.


2020 ◽  
Author(s):  
Ruimin Jiao ◽  
Man Huang ◽  
Weina Zhang ◽  
Zhishun Liu

Abstract Background : Acne vulgaris (AV) is a common chronic dermatologic disease that tends to impair the appearance and the quality of life (QoL) of patients. Although several trials have indicated the effectiveness of acupuncture for treatment of patients with AV, the results of these trials have been contested owing to potential bias in their design. Thus, there is a lack of robust data to evaluate the efficacy of acupuncture in patients with AV. In addition, none of the previous clinical trials of acupuncture therapy for AV used QoL as a primary outcome or employed a sham acupuncture control arm. The aim of the study is to evaluate the effect of acupuncture on the symptoms and the QoL of patients with moderate or severe AV. Methods/design: One hundred eligible participants with AV will be randomly assigned to acupuncture or sham acupuncture groups (1:1 allocation). All participants will receive 4-week treatment comprising of a total of 12 sessions (3 sessions per week). The primary outcome will be change from baseline in the Skindex-16 scale total score at treatment completion. The secondary outcomes will be: Skindex-16 subscale score; the Dermatology Life Quality Index scale total score; the total lesion count and inflammatory lesion count; visual analogue scale scores for assessment of itch and pain; patient expectations of acupuncture; and the blinding of the effect of sham acupuncture. Follow-up evaluation will be performed at weeks 16 and 28. All outcome analyses will be performed in the intention-to-treat population. Discussion: We expect to evaluate the effectiveness of acupuncture in ameliorating the symptoms and improving the QoL of patients with moderate or severe AV compared with sham acupuncture with more robust evidence. The limitations of the trial design are its single center scope, relatively small sample size, and lack of blinding of the acupuncturists. Trial Registration: Chinese Clinical Trial Registry, ChiCTR-1900023649 (Date of registration: Jan 2, 2019). Keywords: acupuncture, acne vulgaris, quality of life, randomized-controlled trial, protocol.


Trials ◽  
2014 ◽  
Vol 15 (1) ◽  
Author(s):  
Kristian Hillert Winther ◽  
Torquil Watt ◽  
Jakob Bue Bjørner ◽  
Per Cramon ◽  
Ulla Feldt-Rasmussen ◽  
...  

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