Auricular Acupuncture in Patients With Multiple Myeloma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05762250
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Hospital Tuebingen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Claudia Loeffler, Dr
Principal Investigator Affiliation	University Hospital Wuerzburg
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma, Fatigue, Pain, Depression

Arms & Interventions

Arms

Experimental: 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.

No Intervention: Waitlist

Control group: standard treatment / waiting list Patients in the control group will also receive a one-time 30-minute psychoeducational interview at baseline.

Interventions

Other: - Auricular Acupuncture

Within the NADA protocol, 5 defined points on the patient's ears are treated according to a standardized concept (shen men, kidney, lung, liver, vegetative I).

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Claudia Loeffler, Dr

loeffler_C@ukw.de

+49 93120144966

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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