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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University Identifier:
First received: September 13, 2006
Last updated: July 12, 2012
Last verified: July 2012

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.

Condition Intervention
Chronic Myeloproliferative Disorders
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Precancerous Condition
Psychosocial Effects of Cancer and Its Treatment
Procedure: music therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: AL Amyloidosis Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Aggressive NK Cell Leukemia Anaplastic Large Cell Lymphoma Anaplastic Plasmacytoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Angioimmunoblastic T-cell Lymphoma B-cell Lymphoma Burkitt Lymphoma Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia Chronic Myeloproliferative Disorders Chronic Neutrophilic Leukemia Cutaneous T-cell Lymphoma Essential Thrombocythemia Follicular Lymphoma Hairy Cell Leukemia Hodgkin Lymphoma Large Granular Lymphocyte Leukemia Leukemia, B-cell, Chronic Leukemia, T-cell, Chronic Lymphoblastic Lymphoma Lymphoma, Large-cell Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Lymphomatoid Granulomatosis Lymphosarcoma Mantle Cell Lymphoma Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma Mycosis Fungoides Myelodysplastic Syndromes Myelodysplastic/myeloproliferative Disease Myelofibrosis Myeloid Leukemia Plasmablastic Lymphoma Polycythemia Vera Sezary Syndrome Waldenstrom Macroglobulinemia
U.S. FDA Resources

Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • State anxiety as measured by the State-Trait Anxiety Inventory (STAI) questionnaire [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Perceived pain level as measured by the Visual Analogue Scale [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Patient satisfaction as measured by a post-procedure questionnaire [ Time Frame: day 1 ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: June 2006
Study Completion Date: May 2010
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: usual care
Experimental: Music therapy Procedure: music therapy
music played for patient during bone marrow biopsy collection

Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Diagnosis of hematologic malignancy
  • Referred or scheduled for a bone marrow biopsy


  • Must understand written and spoken English


  • Prior bone marrow biopsies allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00376922

United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Principal Investigator: Suzanne C. Danhauer, PhD Comprehensive Cancer Center of Wake Forest University
  More Information

Responsible Party: Comprehensive Cancer Center of Wake Forest University Identifier: NCT00376922     History of Changes
Other Study ID Numbers: CDR0000495315  CCCWFU-98306  CCCWFU-IRB00000468 
Study First Received: September 13, 2006
Last Updated: July 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
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)
atypical chronic myeloid leukemia, BCR-ABL1 negative
blastic phase chronic myelogenous leukemia
chronic eosinophilic leukemia
primary myelofibrosis
chronic myelomonocytic leukemia
chronic neutrophilic leukemia
chronic phase chronic myelogenous leukemia
de novo myelodysplastic syndromes
essential thrombocythemia
extramedullary plasmacytoma
meningeal chronic myelogenous leukemia
myelodysplastic/myeloproliferative neoplasm, unclassifiable
polycythemia vera
previously treated myelodysplastic syndromes
primary systemic amyloidosis
progressive hairy cell leukemia, initial treatment
prolymphocytic leukemia
secondary acute myeloid leukemia
secondary myelodysplastic syndromes
stage III adult T-cell leukemia/lymphoma
stage III chronic lymphocytic leukemia

Additional relevant MeSH terms:
Lymphoproliferative Disorders
Multiple Myeloma
Myelodysplastic Syndromes
Myelodysplastic-Myeloproliferative Diseases
Myeloproliferative Disorders
Neoplasms, Plasma Cell
Precancerous Conditions
Blood Protein Disorders
Bone Marrow Diseases
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Neoplasms by Histologic Type
Pathologic Processes
Vascular Diseases processed this record on May 26, 2016