The Effects of Music Therapy-Based Stress Reduction on Bone Marrow Transplant Recipients

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00032409
First received: March 20, 2002
Last updated: August 17, 2006
Last verified: July 2006

March 20, 2002
August 17, 2006
August 2001
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Complete list of historical versions of study NCT00032409 on ClinicalTrials.gov Archive Site
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The Effects of Music Therapy-Based Stress Reduction on Bone Marrow Transplant Recipients
The Effects of Music Therapy-Based Stress Reduction on Bone Marrow Transplant Recipients

The purpose of this study is to determine the effects of music therapy-based relaxation stress/reduction strategies on the frequency/severity of toxic side-effects of marrow ablative chemotherapy and the timing of immune reconstitution in patients undergoing bone marrow/stem cell transplantation.

The regimen-related toxicities associated with bone marrow transplantation (BMT) can be severe and even life threatening. The overall goal of this randomized controlled pilot study in BMT patients is to determine the effect of relaxation/stress reduction strategies on: (1) the frequency/severity of toxic side effects of marrow ablative chemotherapy, and (2) the timing of immune reconstitution. Substantial literature indicates that music therapy-based interventions are effective in inducing relaxation and also affect immune function by modulating circulating and salivary levels of such agents as cortisol, immunoglobulin A, interleukin-1, natural killer cells, and a variety of other immune system-related substances. Over the past two years, we have provided music therapy-based stress reduction/relaxation interventions to a convenience sample of patients undergoing BMT. Preliminary findings from this pilot feasibility study demonstrate that patients report significantly decreased pain (p< .004) and sense of nausea (p < .001) following an intervention. Average time-to-engraftment was 13.5 (+/- 2.85) days as compared to 15.5 (+/- 4.40) days (p < .O1) for a group of historical controls matched on diagnosis, type of transplant, conditioning regimen, date of transplant, age, and gender. Although highly promising, our data are limited by lack of randomization, an appropriate control condition, measurement of psychologic factors known to influence outcome in BMT, and systematic monitoring of early phase markers of immune reconstitution that could help explain the phenomena we have observed. This proposal corrects these shortcomings and especially highlights the potential mediational effect of cytokine release on regimen-related toxicities and the timing of immune reconstitution.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Bone Marrow Transplantation
  • Stem Cell Transplantation
Behavioral: Music therapy-based relaxation/stress reduction
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2004
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Inclusion:

Recipient of bone marrow/stem cell transplant

Exclusion:

None

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00032409
R21 AT000895-01
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National Center for Complementary and Alternative Medicine (NCCAM)
National Cancer Institute (NCI)
Principal Investigator: Olle Jane Z. Sahler, MD University of Rochester
National Center for Complementary and Alternative Medicine (NCCAM)
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP