The effects of acupuncture on sleep quality and psychological symptoms of patients with insomnia: study protocol for a randomized controlled trial
- Conditions
- insomnia
- Registration Number
- ITMCTR2100005096
- Lead Sponsor
- Shaanxi University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Meet the diagnostic criteria for insomnia in the Diagnostic and Statistical Manual of Mental Disorders;
2. Aged 18 to 65 years (male or female);
3. Experience at least 3 times a week for more than 1 month;
4. Do not take any drugs to improve insomnia or stop the drug for more than 3 weeks;
5. Have psychological symptoms such as anxiety (self-reported anxiety scale SAS score) >= 50) or depression (self-reported depression scale SDS score) >= 50);
6. Consent to participate in the trial and be randomly assigned to any study group.
1. Insomnia is caused by neurological diseases, including stroke, Parkinson's disease, etc.;
2. Severe organic diseases and other chronic diseases, including heart disease, liver or kidney disease, thrombocytopenia with bleeding tendency;
3. Women of childbearing age who are pregnant or who have not taken appropriate birth control measures;
4. Severe episodes of fainting or fear of blood during acupuncture;
5. Acupoint infection or inflammation;
6. Alcohol and/or other drug abuse or dependence.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index score;
- Secondary Outcome Measures
Name Time Method Medical Outcomes Study 36-Item Short-Form Health Survey;self-assessment anxiety scale;self-assessment anxiety scale;