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


Phase 2
18 Years
N/A
Not Enrolling
Both
Bone Marrow Transplantation, Stem Cell Transplantation

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Trial Information

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


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.

Inclusion Criteria


Inclusion:

Recipient of bone marrow/stem cell transplant

Exclusion:

None

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Olle Jane Z. Sahler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester

Authority:

United States: Federal Government

Study ID:

R21 AT000895-01

NCT ID:

NCT00032409

Start Date:

August 2001

Completion Date:

June 2004

Related Keywords:

  • Bone Marrow Transplantation
  • Stem Cell Transplantation
  • Music Therapy
  • Relaxation Therapy
  • Stress Reduction
  • Bone Marrow Transplantation
  • Stem Cell Transplantation

Name

Location

University of Rochester Medical Center Rochester, New York  14642