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

NCT ID: NCT06169267

Last Updated: 2026-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-22

Study Completion Date

2026-06-15

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.

Conditions

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Hematopoietic and Lymphoid System Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group I (no music)

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

Group Type ACTIVE_COMPARATOR

Bone Marrow Aspiration

Intervention Type PROCEDURE

Undergo bone marrow aspiration/biopsy

Bone Marrow Biopsy

Intervention Type PROCEDURE

Undergo bone marrow aspiration/biopsy

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Group II (listen to music)

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

Group Type EXPERIMENTAL

Bone Marrow Aspiration

Intervention Type PROCEDURE

Undergo bone marrow aspiration/biopsy

Bone Marrow Biopsy

Intervention Type PROCEDURE

Undergo bone marrow aspiration/biopsy

Music Therapy

Intervention Type PROCEDURE

Listen to music

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Bone Marrow Aspiration

Undergo bone marrow aspiration/biopsy

Intervention Type PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow aspiration/biopsy

Intervention Type PROCEDURE

Music Therapy

Listen to music

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Biopsy of Bone Marrow Biopsy, Bone Marrow

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Monzr M Al Malki

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2023-09975

Identifier Type: REGISTRY

Identifier Source: secondary_id

22502

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22502

Identifier Type: -

Identifier Source: org_study_id

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