Music in Reducing Anxiety and Pain in Adult Patients Undergoing Bone Marrow Biopsy for Hematologic Cancers or Other Diseases
This study has been completed.
Sponsor:
Comprehensive Cancer Center of Wake Forest University
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00376922
First received: September 13, 2006
Last updated: July 12, 2012
Last verified: July 2012
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Purpose
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 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 |
| 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:
Genetics Home Reference related topics:
essential thrombocythemia
familial acute myeloid leukemia with mutated CEBPA
mycosis fungoides
polycythemia vera
primary myelofibrosis
Sézary syndrome
MedlinePlus related topics:
Acute Myeloid Leukemia
Anxiety
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Fungal Infections
Hodgkin Disease
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
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:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376922
Locations
| 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
Investigators
| Principal Investigator: | Suzanne C. Danhauer, PhD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov 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:
|
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:
|
Neoplasms Leukemia Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Precancerous Conditions Lymphoma, Large-Cell, Immunoblastic |
Myelodysplastic-Myeloproliferative Diseases Neoplasms by Histologic Type Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases |
ClinicalTrials.gov processed this record on May 23, 2013