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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00376922
Recruitment Status : Completed
First Posted : September 15, 2006
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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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.


Condition or disease Intervention/treatment Phase
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 Procedure: music therapy Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : June 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Biopsy
Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Lymphosarcoma Follicular Lymphoma Chronic Lymphocytic Leukemia Multiple Myeloma Mantle Cell Lymphoma Myelodysplastic Syndromes Primary Myelofibrosis Chronic Myeloproliferative Disorders Polycythemia Vera B-cell Lymphoma Cutaneous T-cell Lymphoma Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Diffuse Large B-Cell Lymphoma Leukemia, T-cell, Chronic Adult T-cell Leukemia/lymphoma Waldenstrom Macroglobulinemia Monoclonal Gammopathy of Undetermined Significance Mycosis Fungoides Hodgkin Lymphoma Hairy Cell Leukemia Marginal Zone Lymphoma Essential Thrombocythemia Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Sezary Syndrome Plasmacytoma AL Amyloidosis Myelodysplastic/myeloproliferative Disease Post-transplant Lymphoproliferative Disease Burkitt Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Chronic Neutrophilic Leukemia Aggressive NK Cell Leukemia Lymphomatoid Granulomatosis T-cell Large Granular Lymphocyte Leukemia

Arms and Interventions
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Arm Intervention/treatment
No Intervention: usual care
Experimental: Music therapy Procedure: music therapy
music played for patient during bone marrow biopsy collection


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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376922


Locations
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United States, North Carolina
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
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Principal Investigator: Suzanne C. Danhauer, PhD Wake Forest University Health Sciences
More Information
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00376922    
Other Study ID Numbers: CDR0000495315
CCCWFU-98306
CCCWFU-IRB00000468
First Posted: September 15, 2006    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: July 2012

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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:
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)
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:
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Lymphoma
Leukemia
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Preleukemia
Precancerous Conditions
Myelodysplastic Syndromes
Myeloproliferative Disorders
Lymphoproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Disease
Syndrome
 Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases