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

Phase 3

Recruiting

• Conditions: Hematopoietic and Lymphoid System Neoplasm
• Interventions: Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Other: Questionnaire Administration; Procedure: Music Therapy

• Registration Number: NCT06169267
• Lead Sponsor: City of Hope Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-05
• Study First Posted: 2023-12-13
• Study Start: 2024-04-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-06-19
• Study Completion: 2025-06-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (no music)	Questionnaire Administration	Patients undergo standard of care bone marrow biopsy and/or aspiration.
Group II (listen to music)	Questionnaire Administration	Patients listen to music while undergoing standard of care bone marrow biopsy and/or aspiration.
Group II (listen to music)	Music Therapy	Patients listen to music while undergoing standard of care bone marrow biopsy and/or aspiration.
Group I (no music)	Bone Marrow Aspiration	Patients undergo standard of care bone marrow biopsy and/or aspiration.
Group I (no music)	Bone Marrow Biopsy	Patients undergo standard of care bone marrow biopsy and/or aspiration.
Group II (listen to music)	Bone Marrow Aspiration	Patients listen to music while undergoing standard of care bone marrow biopsy and/or aspiration.
Group II (listen to music)	Bone Marrow Biopsy	Patients listen to music while undergoing standard of care bone marrow biopsy and/or aspiration.

Primary Outcome Measures

Name	Time	Method
Changes in anxiety level	Up to 4 months	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

Secondary Outcome Measures

Name	Time	Method
Pain level	Up to 4 months	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.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States