Hematopoietic and Lymphoid System NeoplasmPhase 3NCT06169267

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

A Phase 3 study testing Bone Marrow Aspiration, Bone Marrow Biopsy and Music Therapy in people with Hematopoietic and Lymphoid System Neoplasm, run by City of Hope Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hematopoietic and Lymphoid System Neoplasm
What is being tested?: Bone Marrow Aspiration, Bone Marrow Biopsy and Music Therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 113 participants
Where: 1 siteUnited States
Study dates: 22 Apr 2024to 1 Jan 2027
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

City of Hope Medical Center
Duarte, California, 91010

Other trials in United States

About this study

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

Read the detailed description

PRIMARY OBJECTIVE:

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:

To determine if patients with lower to no anxiety during bone marrow aspiration and/or biopsy will also experience less pain.

EXPLORATORY OBJECTIVE:

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: Hematopoietic and Lymphoid System Neoplasm
Being tested: Bone Marrow Aspiration, Bone Marrow Biopsy, Music Therapy, Questionnaire Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bone Marrow AspirationProcedure or surgery
Undergo bone marrow aspiration/biopsy
Bone Marrow BiopsyProcedure or surgery
Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow
Undergo bone marrow aspiration/biopsy
Music TherapyProcedure or surgery
Listen to music
Questionnaire AdministrationOther
Ancillary studies

Study groups in NCT06169267
Study group	Role	What they receive
Group I (no music)	Active comparator	Patients undergo standard of care bone marrow biopsy and/or aspiration. Receives: Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Other: Questionnaire Administration
Group II (listen to music)	Experimental	Patients listen to music while undergoing standard of care bone marrow biopsy and/or aspiration. Receives: Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Music Therapy; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Up to 4 months

Secondary outcomes (1)

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.
Measured: Up to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Apr 20241 Jan 2027

First posted13 Dec 2023
Study start22 Apr 2024
Primary completion1 Jan 2027 (estimated)
Study completion1 Jan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hematopoietic and Lymphoid System NeoplasmStudies of the same condition, open and under way.
More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 113 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06169267
Sponsor's protocol ID: 22502
Other IDs: NCI-2023-09975, 22502, P30CA033572
Status last verified: Oct 2026
First submitted: 5 Dec 2023
Last updated: 22 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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