ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
The Effects of Music Therapy-Based Stress Reduction on Bone Marrow Transplant Recipients

This study has been completed.

Sponsors and Collaborators: National Center for Complementary and Alternative Medicine (NCCAM)
National Cancer Institute (NCI)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00032409
  Purpose

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.


Condition Intervention Phase
Bone Marrow Transplantation
Stem Cell Transplantation
Behavioral: Music therapy-based relaxation/stress reduction
Phase II

MedlinePlus related topics:   Bone Marrow Transplantation    Stress   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   The Effects of Music Therapy-Based Stress Reduction on Bone Marrow Transplant Recipients

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:   50
Study Start Date:   August 2001
Estimated Study Completion Date:   June 2004

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion:

Recipient of bone marrow/stem cell transplant

Exclusion:

None

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032409

Locations
United States, New York
University of Rochester Medical Center    
      Rochester, New York, United States, 14642

Sponsors and Collaborators

Investigators
Principal Investigator:     Olle Jane Z. Sahler, MD     University of Rochester    
  More Information

Study ID Numbers:   R21 AT000895-01
First Received:   March 20, 2002
Last Updated:   August 17, 2006
ClinicalTrials.gov Identifier:   NCT00032409
Health Authority:   United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Music Therapy  
Relaxation Therapy  
Stress Reduction  
Bone Marrow Transplantation  
Stem Cell Transplantation  

Study placed in the following topic categories:
Stress

ClinicalTrials.gov processed this record on September 04, 2008




Links to all studies - primarily for crawlers