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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic and Lymphoid System Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Music Therapy

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 Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope Medical Center
      • Contact: Monzr M. Al Malki; Phone Number: 626-218-2405; Email: malmalki@coh.org
      • Principal Investigator: Monzr M. Al Malki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I (no music); Patients undergo standard of care bone marrow biopsy and/or aspiration.	Other: Questionnaire Administration; Ancillary studies; Procedure: Bone Marrow Aspiration; Undergo bone marrow aspiration/biopsy; Procedure: Bone Marrow Biopsy; Undergo bone marrow aspiration/biopsy; Other Names: Biopsy of Bone Marrow; Biopsy, Bone Marrow
Experimental: Group II (listen to music); Patients listen to music while undergoing standard of care bone marrow biopsy and/or aspiration.	Other: Questionnaire Administration; Ancillary studies; Procedure: Bone Marrow Aspiration; Undergo bone marrow aspiration/biopsy; Procedure: Bone Marrow Biopsy; Undergo bone marrow aspiration/biopsy; Other Names: Biopsy of Bone Marrow; Biopsy, Bone Marrow; Procedure: Music Therapy; Listen to music

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 4 months

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Monzr M Al Malki, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2024
• Primary Completion (Estimated): December 19, 2024
• Study Completion (Estimated): December 19, 2024

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 22502 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2023-09975 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No