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The effects of acupuncture on sleep quality and psychological symptoms of patients with insomnia: study protocol for a randomized controlled trial

The effects of acupuncture on sleep quality and psychological symptoms of patients with insomnia: study protocol for a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005096
Enrollment
Unknown
Registered
2021-07-24
Start date
2021-10-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insomnia

Interventions

control group:sham acupuncture

Sponsors

Shaanxi University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index score;

Secondary

MeasureTime frame
Medical Outcomes Study 36-Item Short-Form Health Survey;self-assessment anxiety scale;self-assessment anxiety scale;

Countries

China

Contacts

Public ContactSheng Gang

Shaanxi Provincial Hospital of Chinese Medicine

drwhat@163.com+86 13669289352

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026