Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer (EOMI)

Universität Duisburg-Essen

Status

Completed

Conditions

Breast Neoplasm

Treatments

Procedure: Ear acupuncture

Behavioral: Psychoeducation

Study type

Interventional

Funder types

Other

Identifiers

NCT03874598

KVC 0/100/2018 (Other Grant/Funding Number)

18-8214-BO

Details and patient eligibility

About

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, fatigue, quality of life, stress, and psychological well-being can be achieved. In addition, a proinflammatory cytokine will be meassured.

Enrollment

52 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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