Auricular Acupressure for the Prevention of Sleep Disorder in Breast Cancer Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Sleep disturbance assessed by PSQI
研究概览
简要总结
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.
详细描述
Breast cancer (BC) patients frequently experience sleep disturbances throughout the treatment continuum, with prevalence rates as high as 60-87%. These disturbances are associated with increased physical and psychological burden, impaired treatment adherence, and reduced quality of life. Chemotherapy and hormone therapy, particularly those involving corticosteroids such as dexamethasone, have been identified as major contributors to sleep disruption. Although pharmacological approaches are commonly used to manage sleep issues, they are often accompanied by side effects and limited long-term efficacy.
Auricular acupressure (AA), a non-invasive technique derived from Traditional Chinese Medicine, involves stimulating specific ear points using Vaccaria seeds to regulate neurohumoral function. Previous studies have demonstrated its effectiveness in general populations with insomnia, but rigorous evidence supporting its role in cancer-related sleep disturbance-especially among BC patients-remains limited.
This double-blind, randomized, sham-controlled trial aims to evaluate the effectiveness of AA in preventing sleep disturbances in BC patients undergoing chemotherapy or hormone therapy. A total of 128 participants with stage I-III BC and no pre-existing sleep disorders will be randomized in a 1:1 ratio to receive either AA or sham AA over a 12-week period. Vaccaria seeds will be applied to five auricular points in the intervention group, while identical patches without seeds will be used in the sham group. Both groups will receive standardized sleep hygiene education.
The primary outcome is sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes include fatigue (BFI-T), anxiety and depression (HADS), and hypnotic medication use. Assessments will be conducted at baseline and during follow-up at weeks 4, 8, 12, and 16. Statistical analysis will use Generalized Estimating Equations (GEE) to compare changes over time between groups.
This study is expected to provide high-quality evidence on the use of AA as a complementary strategy for sleep disturbance prevention in BC patients, addressing a critical yet under-recognized aspect of supportive cancer care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors are blinded to group allocation. Randomization was performed using stratified block randomization by an independent statistician. Identical adhesive patches were used in both groups to maintain participant blinding. Outcome assessors were not involved in the intervention procedures and were unaware of participant group assignments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Auricular Acupressure (AA)
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.
干预措施: Auricular Acupressure with Vaccaria Seeds (Behavioral)
Sham Auricular Acupressure
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.
干预措施: Sham Auricular Acupressure (No Seeds) (Behavioral)
结局指标
主要结局
Sleep disturbance assessed by PSQI
时间窗: Baseline, Week 4, Week 8, Week 12, and follow-up at Week 16
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated 19-item self-report questionnaire.
次要结局
- Fatigue Severity Assessed by BFI-T(Baseline, Week 4, Week 8, Week 12)
- Anxiety and Depression (assessed by HADS)(Baseline, Week 4, Week 8, Week 12)
- Hypnotic Medication Use(Week 4, Week 8, Week 12)