Auricular Acupressure for Sleep Disorder Prevention in Breast Cancer
A legfontosabb adatok
- Ki végzi
- Chang Gung Memorial Hospital
- Hol
- Tajvan1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Toborzás még nem indult
- Résztvevők
- 128 fő, tervezett
- Kezdés
- 2025. jún. 1.
- Várható befejezés
- 2026. dec. 31.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport színlelt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Auricular Acupressure with Vaccaria Seeds
- Sham Auricular Acupressure (No Seeds)
- A regiszteradat frissítve
- 2025. május 11.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for women with stage I-III breast cancer who are having chemotherapy or hormone therapy and do not yet have sleep problems. It tests ear acupressure to prevent sleep problems.
- Életkor
- 18 years or older
- Nem
- Women only
- A betegség stádiuma
- Stage I-III breast cancer, confirmed by tissue testing. Stage IIIB, inflammatory or spread (metastatic) breast cancer cannot join.
- Korábbi kezelés
- Must be scheduled for at least four cycles of chemotherapy before or after surgery, or be currently receiving hormone therapy.
- Biomarker vagy leletérték
- Pittsburgh Sleep Quality Index (PSQI) score < 5 at the start, meaning no existing sleep disorder.
A részvétel fő kizáró okai
- Pregnant or breastfeeding
- Existing anemia or blood disorders
- History of alcohol or substance abuse
- Hormone (endocrine) disorders, other conditions affecting sleep, or active psychiatric disorders that interfere with taking part
- Skin lesions, infections or allergy to adhesive patches on both ears, or currently using other sleep-related complementary therapies
A regiszter feltételei, szó szerint
Mind a 2 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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)
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
Abstract
A teljes eredeti leírásKevesebb
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.
A vizsgálat 2 csoportja
- Auricular Acupressure (AA)A vizsgált kezelés
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.
Kezelés: Auricular Acupressure with Vaccaria Seeds
- Sham Auricular AcupressureSzínlelt kezelés, összehasonlításként
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.
Kezelés: Sham Auricular Acupressure (No Seeds)
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Auricular Acupressure for the Prevention of Sleep Disorder in Breast Cancer Patients: A Randomized Controlled Trial
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
- A regiszteradat frissítve
- 2025. május 11.