Auricular Acupuncture in Patients With Multiple Myeloma
- Conditions
- PainMultiple MyelomaFatigueDepression
- Interventions
- Other: Auricular Acupuncture
- Registration Number
- NCT05762250
- Lead Sponsor
- University Hospital Tuebingen
- Brief Summary
In the present study, the effect of ear acupressure treatment according to the NADA protocol on the quality of life of patients with multiple myeloma (all stages) will be investigated. Furthermore, the effect of ear acupressure on anxiety and depression, pain, fatigue and sleep of the patients will be assessed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 125
- Adult patients with multiple myeloma (all stages) on current therapy, who suffer from persistent disease- or therapy-associated symptoms and limitations (screening by distress thermometer, score ≥ 5)
- Informed consent.
- medical reasons or
- a mental condition which, in the opinion of the investigator, does not allow the patient to participate in the study,
- a planned radiation therapy in the area of the skull (to avoid potential scattered radiation),
- a missing legally binding signature on the informed consent form,
- participation in another acupuncture/acupressure study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Auricular Acupuncture Auricular Acupuncture Intervention group: Ear acupressure is performed on both ears with permanent pellets according to the NADA (National Acupuncture Detoxification Association) protocol over a period of 8 weeks (presentation at the study center 1x/week, application of the acupressure patches there; these remain on both ears for 5 days and should be massaged 3x/day by the patients themselves according to the instructions provided). In addition, patients receive a 30-minute psychoeducational talk at the first treatment appointment to promote their own health competence.
- Primary Outcome Measures
Name Time Method Change in disease-specific quality of life (FACT-MM) after 8 weeks (end of intervention) The FACT-MM can depict a more comprehensive picture of the patient's health status and collects data on precisely those areas that are most important to the patient himself.
The diagnosis-specific subscale developed in this process assesses pain, fatigue, physical activity, emotional health, and cognitive abilities and represents the primary outcome parameter in this study.
- Secondary Outcome Measures
Name Time Method Change of individual symptom burden after 8 weeks (end of intervention) Individual symptom burden - patients are asked to rate their 3 most distressing symptoms on a Numerical Rating Scale.
Change of Fatigue 12 weeks post-intervention The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions.
Change of pain 12 weeks post-intervention Improvement of pain (FACT-MM) questionnaire
Change of sleep disorders and sleep quality 12 weeks post-intervention The Pittsburgh Sleep Quality Index (PSQI) was developed as a standardized self-assessment questionnaire by the University of Pittsburgh to elicit quality of sleep using qualitative and quantitative questions at a 4-week interval
Change in anxiety and depressiveness 12 weeks post-intervention The four-item PHQ-4 is part of the PHQ-D, a health questionnaire for patients, and is composed of the PHQ-2, a two-item depression scale, and the GAD-2, a two-item anxiety scale.
Number of pateints with adverse events through study completion, an average of 3 Years Tolerability of the application
Trial Locations
- Locations (2)
Robert Bosch Krankenhaus
🇩🇪Stuttgart, Germany
University Hospital Wuerzburg
🇩🇪Wuerzburg, Germany