Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032409
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2002-03-20
Brief Title:
The Effects of Music Therapy-Based Stress Reduction on Bone Marrow Transplant Recipients
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
The Effects of Music Therapy-Based Stress Reduction on Bone Marrow Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effects of music therapy-based relaxation stressreduction strategies on the frequencyseverity of toxic side-effects of marrow ablative chemotherapy and the timing of immune reconstitution in patients undergoing bone marrowstem 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 relaxationstress reduction strategies on 1 the frequencyseverity 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 reductionrelaxation 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 135 - 285 days as compared to 155 - 440 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None