Insomnia treatment in patients with breast cancer Mental and Behavioural Disorders
Conditions
Interventions
Current interventions as of 13/12/2023:
Participants will receive acupuncture therapy for “regulating spirit and soothing liver” for 8 weeks.
Time points are as follows:
Visit 1: Screening
Visit 2: T
Sponsors
Beijing Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 13/12/2023: 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 Previous primary outcome measure: 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 13/12/2023: Outcome measures are assessed at baseline (before treatment initiation), 2 and 4 weeks after the first acupuncture, and 1 and 3 months after the last acupuncture session unless otherwise stated: 1. Level of anxiety measured using the Generalized Anxiety Disorder (GAD-7) questionnaire 2. Level of anxiety measured using the Patient Health Questionnaire (PHQ9) 3. Serum 5-HT concentration measured using Enzyme-linked immunosorbent assay (ELISA) 4. Temporary sleeping medication use measured using a Temporary Sleeping Medication Record Form 5. Level liver depression measured using TCM Liver Depression Symptom Assessment Table 6. Adverse events, including discomfort or bruising at the sites of needle insertion, nausea, or feeling faint, measured using participants reporting up to the 6-week acupuncture session Previous secondary outcome measures: Outcome measures are assessed at baseline (before treatment initiation), 2 and 4 weeks after the first acupuncture, and 1 and 3 months after the last acupuncture session unless otherwise stated: 1. Level of anxiety measured using the Generalized Anxiety Disorder (GAD-7) questionnaire 2. Level of anxiety measured using the Patient Health Questionnaire (PHQ9) 3. Quality of life measured using the Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) questionnaire 4. Serum 5-HT concentration measured using Enzyme-linked immunosorbent assay (ELISA) 5. Temporary sleeping medication use measured using a Temporary Sleeping Medication Record Form 6. Level liver depression measured using TCM Liver Depression Symptom Assessment Table 7. Adverse events, including discomfort or bruising at the sites of needle insertion, nausea, or feeling faint, measured using participants reporting up to the 6-week acupuncture session | — |
Countries
China
Outcome results
None listed