Clinical trial · Interventional
Auricular Acupressure for Sleep Disorder Prevention in Breast Cancer
Auricular Acupressure for the Prevention of Sleep Disorder in Breast Cancer Patients: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Abstract Background: Sleep disturbances are highly prevalent among breast cancer (BC) patients, especially during chemotherapy, significantly affecting quality of life and treatment adherence. Conventional pharmacologic treatments for sleep disorders may cause side effects and are not always effective. Auricular acupressure (AA), a non-invasive alternative therapy, has demonstrated promising effects on sleep improvement. However, high-quality evidence for its use in BC patients remains limited. Objective: This study aims to evaluate the effectiveness of auricular acupressure in preventing sleep disturbances in breast cancer patients undergoing chemotherapy. Methods: This double-blind, randomized, sham-controlled trial will recruit 128 participants diagnosed with stage I-III breast cancer who are undergoing chemotherapy or hormone therapy. Eligible participants will be randomly assigned in a 1:1 ratio to receive either auricular acupressure (AA) or sham AA, in addition to usual care. The intervention will be administered over a 12-week period, followed by a 4-week follow-up. In the AA group, Vaccaria seeds will be applied to five specific auricular acupoints. In the sham AA group, identical adhesive patches without seeds will be applied to the same acupoints. Both groups will receive the same treatment schedule and standardized care instructions to ensure blinding. The primary outcome is sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI) at baseline, and at weeks 4, 8, 12, and 16. Secondary outcomes include fatigue (measured by the BFI-T), anxiety and depression (measured by the HADS), and hypnotic medication use, assessed at baseline, and at weeks 4, 8, and 12. Statistical analysis will be performed using Generalized Estimating Equations (GEE) to examine changes over time and between groups. Expected Results: We hypothesize that AA will significantly improve sleep quality and reduce symptom burden compared to sham AA in BC patients. Conclusion: This study will provide rigorous evidence on the efficacy and safety of auricular acupressure as a complementary intervention for sleep disturbance prevention in breast cancer patients receiving chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Sleep Disorders Sleep Disturbance Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Auricular Acupressure with Vaccaria Seeds | Behavioral | — | UNRESOLVED |
| Sham Auricular Acupressure (No Seeds) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Auricular Acupressure (AA)
- description
- Participants in this group receive auricular acupressure using Vaccaria seeds applied to five specific auricular acupoints over 12 weeks. All participants also receive standard sleep hygiene education.
- interventionNames
- Behavioral: Auricular Acupressure with Vaccaria Seeds
- type
- SHAM_COMPARATOR
- label
- Sham Auricular Acupressure
- description
- Participants in this group receive sham auricular acupressure using identical adhesive patches without Vaccaria seeds applied to the same five auricular acupoints. The procedure mimics the true intervention in appearance, duration, and frequency, maintaining participant blinding. All participants also receive standardized sleep hygiene education.
- interventionNames
- Behavioral: Sham Auricular Acupressure (No Seeds)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female, aged 18 years or older Histologically confirmed stage I-III breast cancer Scheduled to undergo at least four cycles of adjuvant or neoadjuvant chemotherapy or currently receiving hormone therapy Pittsburgh Sleep Quality Index (PSQI) score \< 5 at baseline (indicating no pre-existing sleep disorder) Able to provide informed consent and comply with study procedures Exclusion Criteria: * Pregnant or breastfeeding Diagnosed with stage IIIB, inflammatory, or metastatic breast cancer Pre-existing anemia or hematologic disorders History of alcohol or substance abuse Diagnosed endocrine disorders or other medical conditions affecting sleep Active psychiatric disorders interfering with participation Skin lesions, infections, or allergy to adhesive patches on both ears Currently undergoing other complementary sleep-related therapies (e.g., aromatherapy, massage, herbal medicine, health supplements)
References
Publications (0)
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