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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00032409
Enrollment
50
Registered
2002-03-22
Start date
2001-08-31
Completion date
2004-06-30
Last updated
2006-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Marrow Transplantation, Stem Cell Transplantation

Keywords

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

Brief summary

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.

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.

Interventions

BEHAVIORALMusic therapy-based relaxation/stress reduction

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
National Center for Complementary and Integrative Health (NCCIH)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion: Recipient of bone marrow/stem cell transplant Exclusion: None

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026