NCT06169267

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P25-P50 for phase_3

Timeline
1mo left

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Apr 2024Jun 2026

First Submitted

Initial submission to the registry

December 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

April 22, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

December 5, 2023

Last Update Submit

January 26, 2026

Conditions

Hematopoietic and Lymphoid System Neoplasm

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Pain level

    Up to 4 months

Study Arms (2)

Group I (no music)

ACTIVE COMPARATOR

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

Procedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyOther: Questionnaire Administration

Group II (listen to music)

EXPERIMENTAL

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

Procedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Music TherapyOther: Questionnaire Administration

Interventions

Bone Marrow BiopsyPROCEDURE

Undergo bone marrow aspiration/biopsy

Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow
Group I (no music)Group II (listen to music)
Music TherapyPROCEDURE

Listen to music

Group II (listen to music)
Questionnaire AdministrationOTHER

Ancillary studies

Group I (no music)Group II (listen to music)
Bone Marrow AspirationPROCEDURE

Undergo bone marrow aspiration/biopsy

Group I (no music)Group II (listen to music)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Interventions

BiopsyMusic Therapy

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative TechniquesSensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Monzr M Al Malki

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2023

First Posted

December 13, 2023

Study Start

April 22, 2024

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

June 15, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

US(1)