Auricular acupuncture for insomnia in female patients with non-metastatic breast cancer: study protocol for a multicenter, randomized, controlled clinical trial - Scorecard - MDSpire
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Auricular acupuncture for insomnia in female patients with non-metastatic breast cancer: study protocol for a multicenter, randomized, controlled clinical trial
Clinical Scorecard: Auricular Acupuncture as a Treatment for Insomnia in Women with Non-Metastatic Breast Cancer: Protocol for a Multicenter Randomized Controlled Trial
At a Glance
Category
Detail
Condition
Insomnia in women with non-metastatic breast cancer
Key Mechanisms
Auricular acupuncture stimulates specific auricular points to activate the auricular branch of the vagus nerve, regulating physiological processes related to insomnia.
Target Population
Women with stage I-III non-metastatic breast cancer experiencing insomnia.
Care Setting
Multicenter clinical trial across three hospitals.
Key Highlights
324 patients will be randomly assigned to either the AA group or the NAA group.
Treatment duration is 4 weeks with follow-up assessments at weeks 8 and 16.
Primary outcome is treatment response rate at week 4.
Secondary outcomes include changes in insomnia severity and quality of life metrics.
Study aims to provide evidence for the efficacy and safety of auricular acupuncture.
Guideline-Based Recommendations
Diagnosis
Insomnia assessed using DSM-5 criteria, with symptoms occurring at least three nights per week for ≥1 month.
Management
Auricular acupuncture as a non-pharmacological treatment option.
Monitoring & Follow-up
Follow-up assessments at weeks 8 and 16 to evaluate treatment outcomes.
Risks
Potential risks and benefits will be communicated to participants before informed consent.
Patient & Prescribing Data
Women with stage I-III breast cancer diagnosed according to NCCN and AJCC guidelines.
Auricular acupuncture combined with self-administered acupressure and home-based needle replacement.
Clinical Best Practices
Develop a comprehensive standard operating procedure for auricular acupuncture.
Provide online guidance for self-administration of auricular acupuncture.
