Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial
| العنوان: | Acupuncture for insomnia with short sleep duration: protocol for a randomised controlled trial |
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| المؤلفون: | Yun-Fei Chen, Yi-xin Zheng, Cong Wang, Yang Wenjia, Xin-yu Chen, Fu Cong, Jing Wang, Wen-lin Xu, Jin-jin Li, Yu Xintong |
| المصدر: | BMJ Open, Vol 10, Iss 3 (2020) BMJ Open |
| بيانات النشر: | BMJ Publishing Group, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | medicine.medical_specialty, China, medicine.drug_class, Beck Anxiety Inventory, Acupuncture Therapy, law.invention, Pittsburgh Sleep Quality Index, Hypnotic, Randomized controlled trial, law, Sleep Initiation and Maintenance Disorders, Insomnia, Acupuncture, Medicine, Humans, Single-Blind Method, Randomized Controlled Trials as Topic, business.industry, Beck Depression Inventory, Correction, Actigraphy, General Medicine, Physical therapy, medicine.symptom, business |
| 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. |
| اللغة: | English |
| تدمد: | 2044-6055 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c3ab84ad9523d02dda2a475cf94abbff https://bmjopen.bmj.com/content/10/3/e033731.full |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....c3ab84ad9523d02dda2a475cf94abbff |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 20446055 |
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