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Completed

NCT Number: NCT00376922

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

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.

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Key information

Conditions

Chronic Myeloproliferative Disorders Amyloidosis Blast Crisis Blood Coagulation Disorders Blood Platelet Disorders Blood Protein Disorders Bone Marrow Diseases Bone Marrow Neoplasms Burkitt Lymphoma Carcinogenesis Cardiovascular Diseases Cell Transformation, Neoplastic Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Virus Infections Disease Attributes Epstein-Barr Virus Infections Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Hodgkin Disease Hypergammaglobulinemia Immune System Diseases Immunoblastic Lymphadenopathy Immunoglobulin Light-chain Amyloidosis Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Biphenotypic, Acute Leukemia, Hairy Cell Leukemia, Large Granular Lymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Mast-Cell Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Chronic Leukemia, Neutrophilic, Chronic Leukemia, Prolymphocytic Leukemia, T-Cell Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorder Lymphoproliferative Disorders Mast Cell Activation Disorders Mastocytosis Mastocytosis, Systemic Metabolic Diseases Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma Multiple Myeloma and Plasma Cell Neoplasm Mycosis Fungoides Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myelodysplastic/Myeloproliferative Neoplasms Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Neoplastic Processes Neurologic Manifestations Nutritional and Metabolic Diseases Pain Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Pdgfra-Associated Chronic Eosinophilic Leukemia Polycythemia Vera Precancerous Condition Precancerous Conditions Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Primary Myelofibrosis Proteostasis Deficiencies Psychosocial Effects of Cancer and Its Treatment Sezary Syndrome Signs and Symptoms Thrombocythemia, Essential Thrombocytosis Tumor Virus Infections Vascular Diseases Virus Diseases Waldenstrom Macroglobulinemia

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music Therapy

Procedure

music played for patient during bone marrow biopsy collection

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2010
First posted
Sep 15, 2006
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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