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

City of Hope

Status and phase: Active, not recruiting; Phase 3

Conditions: Hematopoietic and Lymphoid System Neoplasm

Treatments: Other: Questionnaire Administration; Procedure: Music Therapy; Procedure: Bone Marrow Biopsy; Procedure: Bone Marrow Aspiration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06169267

22502 (Other Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

NCI-2023-09975 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 113 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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113 participants in 2 patient groups

Group I (no music)

Active Comparator group

Description:

Patients undergo standard of care bone marrow biopsy and/or aspiration.

Treatment:

Procedure: Bone Marrow Aspiration

Procedure: Bone Marrow Biopsy

Other: Questionnaire Administration

Group II (listen to music)

Experimental group

Description:

Patients listen to music while undergoing standard of care bone marrow biopsy and/or aspiration.

Treatment:

Procedure: Bone Marrow Aspiration

Procedure: Bone Marrow Biopsy

Procedure: Music Therapy

Other: Questionnaire Administration