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

INTERVENTION: Participants will receive acupuncture therapy for “regulating spirit and soothing liver” for 4 weeks. Time points are as follows: Visit 1: Screening Visit 2: Treatment initiation, participants will receive acupuncture for 4 weeks Visit 3: 4 weeks after first acupuncture, treatment finish and follow‐up Visit 4: 1 month after first acupuncture, follow‐up Visit 5: 3 months after first acupuncture, follow‐up Patients who meet the inclusion criteria are randomized to one of four treatment groups: Group A (receive normal acupuncture at selected acupoints) Group B (receive shallow acupuncture at selected acupoints) 1. Selected acupoints: GV20(Baihui) GV24(Shenting) EX‐HN1(Sishencong) GB15(Benshen) Ht7(Shenmen) Pc6(Neiguan) Sp6(Sanyinjiao) St36(Zusanli) Sp10(Xuehai) GB34(Yanglingquan) LR3(Taichong) 2. Normal acupuncture therapy: GV20, GV24, EX‐HN1, GB15: The needle tip is inserted 8‐15 mm at a 20°angle to the scalp. Sp6, St36, Sp10, GB34: The needle tip is inserted 40 mm at a 90°angle to the skin. Ht7, Pc6, LR3: The needle tip is inserted 20‐25 mm at a 20°angle to the skin. Each acupoint is used in neutral supplementation and draining methods and retained for 30 minutes. 3. Shallow acupuncture therapy: The blunt needle on a cotton pad is stuck on the same acupoints as the treatment group and retained for 30 minutes. CONDITION: Insomnia treatment in patients with breast cancer ; Mental and Behavioural Disorders PRIMARY OUTCOME: 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 OUTCOME: ; 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; 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