Music in Reducing Anxiety and Pain in Adult Patients Undergoing Bone Marrow Biopsy for Hematologic Cancers or Other Diseases

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT00376922
Collaborator
National Cancer Institute (NCI) (NIH)
65
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2
47
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Study Details

Study Description

Brief Summary

RATIONALE: Listening to relaxing music during a bone marrow biopsy may be effective in reducing anxiety and pain.

PURPOSE: This randomized clinical trial is studying how well music works in reducing anxiety and pain in adult patients undergoing bone marrow biopsy for hematologic cancers or other diseases.

Detailed Description

OBJECTIVES:
  • Determine the feasibility of using music as an intervention to reduce anxiety and perceived pain in adult patients who are undergoing bone marrow biopsy for hematologic cancers or other diseases.

  • Compare differences in state anxiety and perceived pain level between patients treated with or without music intervention.

OUTLINE: This is a randomized, feasibility study. Patients are stratified according to the practitioner performing the procedure. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (music intervention): Patients complete baseline questionnaires that measure anxiety and anticipated pain prior to bone marrow biopsy (BMB). Patients also provide demographic and clinical information, including pre-procedure medications and previous BMB experience. Patients then choose from music compact discs with various types of relaxing music (e.g., classical, country, soft rock, and R&B) and listen to the music through headphones during the bone marrow biopsy for approximately 30 minutes. After the biopsy, patients complete questionnaires that measure their response to the music, in terms of anxiety and perceived pain experienced during the procedure, and their overall level of satisfaction.

  • Arm II (usual care [control]): Patients complete pre-procedure questionnaires, as in arm I, and undergo BMB without music intervention. Post-procedure questionnaires assess patient response to BMB in the absence of music and their level of satisfaction with the procedure.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Use of Music to Reduce Anxiety & Perceived Pain for Adult Patients With Hematological Malignancies Undergoing Bone Marrow Biopsy
Study Start Date :
Jun 1, 2006
Actual Primary Completion Date :
May 1, 2007
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

Arm Intervention/Treatment
No Intervention: usual care

Experimental: Music therapy

Procedure: music therapy
music played for patient during bone marrow biopsy collection

Outcome Measures

Primary Outcome Measures

  1. State anxiety as measured by the State-Trait Anxiety Inventory (STAI) questionnaire [day 1]

  2. Perceived pain level as measured by the Visual Analogue Scale [day 1]

  3. Patient satisfaction as measured by a post-procedure questionnaire [day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:
  • Diagnosis of hematologic malignancy

  • Referred or scheduled for a bone marrow biopsy

PATIENT CHARACTERISTICS:
  • Must understand written and spoken English
PRIOR CONCURRENT THERAPY:
  • Prior bone marrow biopsies allowed

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina United States 27157

Sponsors and Collaborators

  • Wake Forest University Health Sciences
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Suzanne C. Danhauer, PhD, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT00376922
Other Study ID Numbers:
  • CDR0000495315
  • CCCWFU-98306
  • CCCWFU-IRB00000468
First Posted:
Sep 15, 2006
Last Update Posted:
May 30, 2017
Last Verified:
Jul 1, 2012
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wake Forest University Health Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 30, 2017