Status:
COMPLETED
Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer
Lead Sponsor:
Universität Duisburg-Essen
Collaborating Sponsors:
Karl and Veronica Carstens Foundation
Conditions:
Breast Neoplasm
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
The aim of this clinical study is to investigate the extent to which ear acupuncture has an effect on insomnia in women with breast cancer. It will be investigated whether changes in sleep quality, fa...
Eligibility Criteria
Inclusion
- Histological diagnosed non-metastatic breast CAs (TNM stage I-III)
- Existing insomnia (difficulty falling asleep or sleeping through on at least 3 days per week for at least 3 months) according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM 5).
- willingness to participate in the study (at least 8 out of 10 treatments)
- Signed informed consent
Exclusion
- Ongoing or planned chemotherapy, radiation, follow-up treatment or reconstructive plastic surgery during the study period
- Severe physical or psychopharmacologically treated psychiatric comorbidity that prevents a patient from participating in the study
- Pregnancy
- Participation in other clinical trials with behavioural, psychological or complementary medical interventions during the study period
- Regular use of barbiturates, antidepressants or other sleep-inducing drugs, drug abusus, alcoholism
Key Trial Info
Start Date :
June 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2020
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03874598
Start Date
June 12 2019
End Date
February 19 2020
Last Update
May 24 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, Germany, 45276