Randomized controlled study on acupuncture therapy of regulating spirit and soothing liver for insomnia patients with breast cancer
- Conditions
- insomnia patients with breast cancer
- Registration Number
- ITMCTR2200006801
- Lead Sponsor
- Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- Not specified
1. Age between 18 and 60 years, 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 doesnt have 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
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 and/or psychoactive drug users, drug abusers and dependent.
6.Individuals who are afraid or unable to get acupuncture.
7.Individuals who takes medication or other interventions to sleep regularly for a long time.
8.Surgery is scheduled within 1 month.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Therapeutic effect is graded using Pittsburgh sleep Scale (PSQI);
- Secondary Outcome Measures
Name Time Method Temporary use of hpnotic drug;Evaluation of Liver Depression Symptoms in Traditional Chinese Medicine;Patien Health Questionnare,PHQ9;Generalized Anxiety Disorder,GAD-7;Serum serotonin concentration;Adverse event;