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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Use of Music to Reduce Anxiety & Perceived Pain for Adult Patients With Hematological Malignancies Undergoing Bone Marrow Biopsy

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 Summary:

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.


Sponsor: Wake Forest University Health Sciences

Current Primary Outcome:

  • State anxiety as measured by the State-Trait Anxiety Inventory (STAI) questionnaire [ Time Frame: day 1 ]
  • Perceived pain level as measured by the Visual Analogue Scale [ Time Frame: day 1 ]
  • Patient satisfaction as measured by a post-procedure questionnaire [ Time Frame: day 1 ]


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Wake Forest University Health Sciences

Dates:
Date Received: September 13, 2006
Date Started: June 2006
Date Completion:
Last Updated: January 18, 2017
Last Verified: July 2012