Passive Music Intervention for the Reduction of Anxiety in Patients Undergoing Bone Marrow Aspiration and/or Biopsy

Study Overview
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Brief Summary
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This phase III trial compares the effect of adding passive music when undergoing bone marrow biopsy/aspirate versus bone marrow biopsy/aspirate alone in reducing anxiety. Music therapy helps relieve pain or stress and promote well-being. Listening to music during a bone marrow biopsy/aspirate procedure may reduce anxiety during the procedure.

Detailed Description
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PRIMARY OBJECTIVE: I. To determine whether music listening alleviates psychological distress such as anxiety in patients undergoing bone marrow aspiration and/or biopsy that do not require general anesthesia. SECONDARY OBJECTIVE: I. To determine if patients with lower to no anxiety during bone marrow aspiration and/or biopsy will also experience less pain. EXPLORATORY OBJECTIVE: I. To design and implement an evidence-based music intervention protocol that could be used during bone marrow aspiration and/or biopsy. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients undergo standard of care bone marrow biopsy and/or aspiration. GROUP II: Patients listen to music while undergoing standard of care bone marrow biopsy and/or aspiration.

Official Title
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Phase III Intention to Treat Study of the Effect of Passive Music Intervention on Anxiety in Patients Undergoing Bone Marrow Aspiration and/or Biopsy

Conditions
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Hematopoietic and Lymphoid System Neoplasm

Intervention / Treatment
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* Procedure: Bone Marrow Aspiration
* Procedure: Bone Marrow Biopsy
* Procedure: Music Therapy
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented informed consent of the participant and/or legally authorized representative Willingness to participate in the study Ability to read English, or willingness to have one of the staff members help with the questionnaire Age: ≥ 18 years Hematological conditions requiring a bone marrow biopsy and/or aspiration procedure, regardless of their disease state, and experience with such procedures Exclusion Criteria: Hearing impairments, and non-verbal communication Scheduled to undergo a sedated bone marrow biopsy Scheduled to be premedicated with any anxiolytic or pain medication 30 minutes prior to the procedure Unwillingness to listen to music Altered mental health status that would prohibit informed consent and following protocol required instructions Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I (no music)<br>Patients undergo standard of care bone marrow biopsy and/or aspiration. | Procedure: Bone Marrow Aspiration<br>* Undergo bone marrow aspiration/biopsy<br>Procedure: Bone Marrow Biopsy<br>* Undergo bone marrow aspiration/biopsy<br>* Other names: Biopsy, Bone Marrow;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Group II (listen to music)<br>Patients listen to music while undergoing standard of care bone marrow biopsy and/or aspiration. | Procedure: Bone Marrow Aspiration<br>* Undergo bone marrow aspiration/biopsy<br>Procedure: Bone Marrow Biopsy<br>* Undergo bone marrow aspiration/biopsy<br>* Other names: Biopsy, Bone Marrow;Procedure: Music Therapy<br>* Listen to music<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in anxiety level | Measured by State-Trait Anxiety Inventory (STAI) based on the response to 20 anxiety state-related questions, each scaled between 1 and 4, from low to high anxiety | Up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level | The visual analog scale ranging from 0 to 10 will be used to rate the pain level by subjects: 1-3 as mild, 4-6 as moderate and 7-10 as severe. The pain level will be compared between the music and non-music group by two-sample t tests. Univariate and multivariate analysis on pain level will be similar as that for anxiety. | Up to 4 months |