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 (TriCAM)
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|ClinicalTrials.gov Identifier: NCT02976558|
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : February 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hematological Neoplasm Graft-Versus-Host Disease Depression Stem Cell Transplant Complications Quality of Life Leukemia||Behavioral: Clown theatrical Performance Procedure: Acupuncture Behavioral: Music Therapy TaKeTiNa||Not Applicable|
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The allogenic stem cell transplantation (aSCT) is still the only curative approach for many hematological diseases. Despite new therapeutic developments in the past few years, the therapy-associated mortality rate is around 20%. Patients develop a Graft versus Host Disease (GvHD) in 30-70% of the cases, some with persistent, severe progression and often complicated by infections. In severe chronic conditions, physical disabilities such as weakness, paralysis, scarred vulnerable skin, and blindness may occur. A significant reduction in the quality of life of these patients including severe depression is the consequence.
The demand of patients for supplementary therapy possibilities in the sense of an integrative, complementary medicine is great. There are indications that complementary methods can help improve the quality of life and reduce the associated side effects. However, there are no scientific studies to clarify the efficacy or safety of such therapies in the aSCT.
In this project, the investigators examine the influence of three complementary medicine methods, 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.
Acupuncture according to TCM is an evidence-based therapy approach with few side effects for many diseases. In the past few years, not only their superiority over placebo treatment, but also the point-specific effect has been shown. Based on the numerous published data on pain, nausea, fatigue and depression, it can be assumed that acupuncture reduces the side effects of drug therapy in aSCT and thus improves the quality of life of patients.
According to TCM, the points influence the flow of the energy (referred to as "Qi") in the body and stimulate its self-regulation. In addition, each organ system associated to a different emotion. The unimpeded flow of the ongoing arising of emotions and body energies is, according to TCM, a prerequisite for the health of the organism.
In TCM, the acupuncture used to stimulate the self-regulation of the body is accompanied by the regular practice of Qi-Gong or Tai-Qi by the patient to achieve the greatest therapeutic effect between the treatments. This additive component can hardly be realized because of the severely restricted general state of the patients.
In order to mobilize the energy and emotions, this study also implements two further treatment modalities, which are practiced with the patient and which the patient can practice on a daily basis by himself:
TaKeTiNa is a form of music therapy founded by Reinhard Flatischler, in which body, voice and movement are used to develop present consciousness, physical feeling and rhythm skills. It has been used therapeutically for more than 20 years.
Furthermore, the processing of arising emotions needs to be facilitated. Patients undergoing an aSCT are exposed to a deeply invasive and debilitating situation for a period of at least four weeks. Characteristics are social isolation through limited visits as well as confinement to a small room, almost complete loss of the privacy and independence through frequent monitoring and lavation necessary during aSCT. Finally the confrontation with the illness, the side effects of the drug treatment and the possible death. Arising emotions can lead to a blockade in the energy flow of the respective organ according to TCM and can cause illness. Therefore, the introduction of six basic gestures from the clown performance according to the Metzler method (KANA-Institut für Koerperprache Freiburg) is intended to give the patient the opportunity to process his emotions in a playful manner in real time or to communicate them directly to another person without words.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Open Randomized Monocentric Two-armed Controlled Clinical Trial in Parallel Groups to Investigate the Influence of Complementary Medicine (CAM) Interventions on Quality of Life and The Treatment Process of Patients Undergoing Allogenic Stem Cell Transplantation|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||July 2022|
Experimental: Treatment Group
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
Other Name: theatre therapy, humour for health
Acupuncture according to Traditional Chinese Medicine
Behavioral: Music Therapy TaKeTiNa
No Intervention: Control Group
control group. No interventions
- Difference in the Quality of Life of the intervention group compared to the control group [ Time Frame: day 1 of study compared to day 90 of study ]Assessment through FACT-G Questionaire
- Difference in development of GvHD of the intervention group compared to the control group [ Time Frame: day 1 of study compared to day 90 of study ]Assessment through staging of GvHD and required days of hospitalisation
- Difference in development of fungal infections of the intervention group compared to the control group [ Time Frame: day 1 of study compared to day 90 of study ]Assessment through required days of hospitalisation and antimycotic therapy
- Difference in development of bacterial infections of the intervention group compared to the control group [ Time Frame: day 1 of study compared to day 90 of study ]Assessment through required days of hospitalisation and antibiotic therapy
- Difference in development of viral infections including CMV and EBV of the intervention group compared to the control group [ Time Frame: day 1 of study compared to day 90 of study ]Assessment through required days of hospitalisation and antiviral therapy
- Difference in Depression of the intervention group compared to the control group [ Time Frame: day 1 of study compared to day 90 of study ]Assessment through HADS-D questionaire
- Impact of the diagnosis and therapy according to traditional chinese medicine on the difference in development of Infections of the intervention group compared to the control group [ Time Frame: day 1 of study compared to day 90 of study ]Assessment days of hospitalisation and antiinfective therapy
- Impact of the diagnosis and therapy according to traditional chinese medicine on the difference in development of GvHD of the intervention group compared to the control group [ Time Frame: day 1 of study compared to day 90 of study ]Assessment through staging of GvHD and required days of hospitalisation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02976558
|University of Erlangen Nuermberg Medical School||Recruiting|
|Erlangen, Bavaria, Germany, 91054|
|Contact: Ali Behzad, Board Certified MD firstname.lastname@example.org|
|Principal Investigator: Ali Behzad, MD|