breast cancer-related insomnia
Conditions
Interventions
Sham auricular acupuncture group:Sham auricular acupuncture
Auricular acupuncture group:Auricular acupuncture
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meet the above diagnostic criteria for breast cancer with TNM stage I-III; meet the above diagnostic criteria for insomnia with insomnia occurring after the diagnosis of breast cancer and insomnia related to the cancer itself or cancer-related treatment lasting = 1 month; (2) 18 years = age = 75 years female; (3) ECOG score = 2; (4) Index of Sleep Severity (ISI) score = 8; (5) Estimated survival = 6 months; (6) Agreed to participate in the study and signed a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Combined more serious major diseases of the heart liver and kidney; (2) Those who are pregnant breastfeeding or planning to become pregnant within the last 1 month; (3) Those who have surgical plans during the trial period; (4) Those who have a history of drug abuse or addiction; (5) Observers who have taken sedative-hypnotic or antipsychotic medication 2 weeks prior to the baseline visit or who have received other treatments for insomnia (e.g. cognitive-behavioural therapy etc.) 3 months prior to the baseline visit which may affect the efficacy of the treatment; (6) Insomnia due to cancer pain (NRS score =4) or other physical illness; ? (7) People with mental and intellectual abnormalities who cannot understand the provisions of the scales and cannot co-operate in completing the assessment; ? (8) Long-term night work or irregular work and rest; (9) Patients who had received auricular acupuncture treatment within the previous 3 months at the time of enrolment; (10) Ulcers abscesses and skin infections at the site of auricular acupuncture; (11) Those who are allergic to metal and adhesive tape; (12) Those with ear mutilation perforation cartilage deformation or other hindrances to the application of auricular pinning techniques at a specific point; (13) Those who have ear chondritis or serious complications related to the ear; (14) Participating in other clinical medical trial studies within the last month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Health Questionnaire-9(PHQ-9);Sleep diary related indicators : including total sleep duration ( TST ), sleep latency ( SOL ), number of sleep awakenings ( SA ), Wakefulness After Sleep Onset ( WASO ), early morning awakening ( EMA ), average awakening duration ( AA ), sleep efficiency ( SE ).;Treatment remission rate;Generalized Anxiety Disorder Scale ( GAD-7 );Quality of Life Core Scale ( QLQ-C30 );Treatment response rate;Situation of emergency dosage;Changes in the total score of the Insomnia Severity Index ( ISI ) ; | — |
Countries
China
Contacts
Public ContactPing Yin
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed