دورية أكاديمية

Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial

التفاصيل البيبلوغرافية
العنوان: Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial
المؤلفون: Cong Wang, Wen-jia Yang, Xin-tong Yu, Cong Fu, Jin-jin Li, Wen-lin Xu, Yi-xin Zheng, Yun-fei Chen
المصدر: BMJ Open, Vol 10, Iss 3 (2020)
بيانات النشر: BMJ Publishing Group, 2020.
سنة النشر: 2020
المجموعة: LCC:Medicine
مصطلحات موضوعية: Medicine
الوصف: IntroductionInsomnia with short sleep duration has a more serious negative impact on patient health. The existing literature suggests that medication therapy is more effective for this phenotype of insomnia compared with cognitive–behavioural therapy. However, the potential side effects of hypnotic medications hinder their clinical application. Acupuncture has been widely used in the treatment of insomnia, but it remains unclear whether it has therapeutic efficacy for insomnia with short sleep duration. The purpose of this trial is to evaluate the efficacy and safety of acupuncture for insomnia with short sleep duration.Methods and analysisThis study is designed as a randomised, single-centre, single-blinded, placebo acupuncture controlled trial involving 152 participants. Eligible patients will be divided into two groups according to the objective total sleep time: insomnia with normal sleep duration group and insomnia with short sleep duration group. Then, patients in each group will be randomly assigned to two subgroups, the treatment group (acupuncture) and the control group (placebo acupuncture), in a 1:1 ratio with 38 subjects in each subgroup. The primary outcome is the Pittsburgh Sleep Quality Index and the Insomnia Severity Index. Secondary outcomes are actigraphy, the Beck Anxiety Inventory, the Beck Depression Inventory and the Fatigue Severity Scale. All adverse effects will be assessed by the Treatment Emergent Symptom Scale. Outcomes will be evaluated at baseline, post treatment, as well as at 1-week and 1-month follow-up.Ethics and disseminationThis protocol has been approved by the ethics committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine (no. 2019-17). Written informed consent will be obtained from all participants. The results will be disseminated through peer-reviewed journals for publications.Trial registration numberChiCTR1900023473; Pre-results.
نوع الوثيقة: article
وصف الملف: electronic resource
اللغة: English
تدمد: 2044-6055
Relation: https://bmjopen.bmj.com/content/10/3/e033731.full; https://doaj.org/toc/2044-6055
DOI: 10.1136/bmjopen-2019-033731
URL الوصول: https://doaj.org/article/0898042c171c4871bebb53c6c69208d7
رقم الأكسشن: edsdoj.0898042c171c4871bebb53c6c69208d7
قاعدة البيانات: Directory of Open Access Journals
الوصف
تدمد:20446055
DOI:10.1136/bmjopen-2019-033731