The Influence of TaKeTiNa Music Therapy, Traditional Chinese Acupuncture and Clown Theatrical Performance on Quality of Life and the Therapeutic Process of Patients Undergoing Allogenic Stem Cell Transplantation

NCT02976558 | Terminated

• 1 other identifier: CCS Erlangen 0383
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The allogenic stem cell transplantation (aSCT), the only curative approach for many hematological diseases, often leads to severe diseases or chronic conditions, leaving patients with physical disabilities and severe depression and impacting their quality of life in many cases. These consequences are still not adequately addressed by conventional therapies. In this study, the investigators examine the influence of the three complementary medicine methods (CAM) namely acupuncture according to Traditional Chinese Medicine (TCM), music therapy according to the TaKeTiNa method and the psychological disease processing by theatrical clown performance on the quality of life and the therapy process of patients before and after aSCT.

Conditions

Hematological Neoplasm; Graft-Versus-Host Disease; Depression; Stem Cell Transplant Complications; Quality of Life; Leukemia

Keywords

CAM; allogenic Stem Cell Transplantation; Graft-Versus-Host Disease; Depression; Quality of Life; Acupuncture; Traditional chinese Medicine; Integrative medicine; Complementary and Alternative Medicine; Music therapy TaKeTiNa; Clown theatrical performance; Humour; Chemotherapy side effects; Psycho neuro immune system; GvHD; PNEIS; CMV; EBV; holistic medicine

Outcome Measures

Primary Outcomes (1)

• Difference in the Quality of Life of the intervention group compared to the control group

  Assessment through FACT-G Questionaire

  day 1 of study compared to day 90 of study

Secondary Outcomes (8)

• Difference in development of GvHD of the intervention group compared to the control group

  day 1 of study compared to day 90 of study

• Difference in development of fungal infections of the intervention group compared to the control group

  day 1 of study compared to day 90 of study

• Difference in development of bacterial infections of the intervention group compared to the control group

  day 1 of study compared to day 90 of study

• Difference in development of viral infections including CMV and EBV of the intervention group compared to the control group

  day 1 of study compared to day 90 of study

• Difference in Depression of the intervention group compared to the control group

  day 1 of study compared to day 90 of study

Study Arms (2)

Treatment Group

EXPERIMENTAL

Interventions: Acupuncture, music therapy (TaKeTiNa) and Clown theatrical performance starting before allogenic stem cell transplant until three months after transplantation. Interventions each twice a week for 4 weeks, then once a week for 4 weeks, then once every two weeks for 4 weeks

Behavioral: Clown theatrical Performance; Procedure: Acupuncture; Behavioral: Music Therapy TaKeTiNa

Control Group

NO INTERVENTION

control group. No interventions

Interventions

Clown theatrical Performance BEHAVIORAL

Also known as: theatre therapy, humour for health

Treatment Group

Acupuncture PROCEDURE

Acupuncture according to Traditional Chinese Medicine

Treatment Group

Music Therapy TaKeTiNa BEHAVIORAL

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• planned allogenic stem cell transplantation
• patient mentally and intellectually able to understand and sign the form

You may not qualify if:

• Current enrollment in another intervention study
• clinical diagnosis of depression by HADS-D score plus drug therapy for depression at the time of enrollment

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University of Erlangen Nuermberg Medical School

Erlangen, Bavaria, 91054, Germany

Location

Related Publications (11)

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  PMID: 22576252 BACKGROUND

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  PMID: 26685773 BACKGROUND

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  PMID: 17333294 BACKGROUND

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  PMID: 23341529 BACKGROUND

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  PMID: 27716074 BACKGROUND

• Witt CM, Pach D, Brinkhaus B, Wruck K, Tag B, Mank S, Willich SN. Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forsch Komplementmed. 2009 Apr;16(2):91-7. doi: 10.1159/000209315. Epub 2009 Apr 9.

  PMID: 19420954 BACKGROUND

• Fuentealba Cargill F, Biagini Alarcon L. [Acupuncture for postoperative pain, a literature review]. Rev Med Chil. 2016 Mar;144(3):325-32. doi: 10.4067/S0034-98872016000300007. Spanish.

  PMID: 27299818 BACKGROUND

MeSH Terms

Conditions

Hematologic Neoplasms; Graft vs Host Disease; Depression; Leukemia

Interventions

Health; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases; Behavioral Symptoms; Behavior; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Population Characteristics; Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: November 29, 2016
• Study Start: December 1, 2016
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-12

Locations

DE (1)