Acupuncture therapy of regulating spirit and soothing liver” for treating insomnia in patients with breast cancer

Not Applicable

• Conditions: Insomnia treatment in patients with breast cancer; Mental and Behavioural Disorders

• Registration Number: ISRCTN12913513
• Lead Sponsor: Beijing Hospital of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-07
• Last Update Posted: 8 January 2024
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

1. Aged between 18 and 60 years old and female
2. Confirm the diagnosis of breast cancer and meet the diagnostic criteria for insomnia in DSM-V
3. PSQI score=10
4. Individuals who do not have a language disorder or mental retardation and can answer and finish the questionnaire smoothly
5. Signed informed consent form and volunteered to participate in this study
6. Individuals who have a correct understanding of acupuncture studies and have good compliance with the observation and evaluation of researchers

Exclusion Criteria

1. Individuals who have epilepsy, diabetes, cardiovascular disease, renal failure, hypertension, metabolic diseases and other major diseases
2. Individuals who have depression, anxiety, schizophrenia and other serious mental disorders with irregular drug use
3. History of sleep apnea syndrome, restless legs syndrome and other sleep disorders
4. Lactating women, pregnant women or women of childbearing age who are planning to become pregnant in a short time
5. Alcoholics and/or psychoactive drug users, drug abusers and dependents
6. Individuals who are afraid or unable to get acupuncture
7. Individuals who take medication or other interventions to sleep regularly for a long time
8. Surgery is scheduled within 1 month

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 13/12/2023:<br>Therapeutic effect measured using the Pittsburgh sleep Scale (PSQI) at baseline (before treatment initiation), 2, 4, 6 and 8 weeks after the first acupuncture, and 1 and 3 months after the last acupuncture session<br><br><br><br><br>Previous primary outcome measure:<br>Therapeutic effect measured using the Pittsburgh sleep Scale (PSQI) at baseline (before treatment initiation), 2 and 4 weeks after the first acupuncture, and 1 and 3 months after the last acupuncture session