Music in Reducing Anxiety and Pain in Adult Patients Unde... | NCT00376922 | Trialant
NCT00376922
Sponsor
Wake Forest University Health Sciences
Status
Completed
Last Update Posted
May 30, 2017Actual
Enrollment
65Actual
Phase
Not Applicable
Conditions
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Pain
Precancerous Condition
Psychosocial Effects of Cancer and Its Treatment
Interventions
music therapy
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00376922
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000495315
Secondary IDs
ID
Type
Description
Link
CCCWFU-98306
CCCWFU-IRB00000468
Brief Title
Music in Reducing Anxiety and Pain in Adult Patients Undergoing Bone Marrow Biopsy for Hematologic Cancers or Other Diseases
Official Title
Use of Music to Reduce Anxiety & Perceived Pain for Adult Patients With Hematological Malignancies Undergoing Bone Marrow Biopsy
Acronym
Not provided
Organization
Wake Forest University Health SciencesOTHER
Status Module
Record Verification Date
Jul 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 2006
Primary Completion Date
May 2007Actual
Completion Date
May 2010Actual
First Submitted Date
Sep 13, 2006
First Submission Date that Met QC Criteria
Sep 13, 2006
First Posted Date
Sep 15, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 25, 2017
Last Update Posted Date
May 30, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Wake Forest University Health SciencesOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Pain
Precancerous Condition
Psychosocial Effects of Cancer and Its Treatment
Keywords
pain
psychosocial effects of cancer and its treatment
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)