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

Hematopoietic and Lymphoid System Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06169267
• Other study ID #: 22502
• Secondary ID: NCI-2023-0997522
• Status: Recruiting
• Phase: Phase 3
• Start date: April 22, 2024
• Est. completion date: December 19, 2024

Study information

• Verified date: May 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Listening to music during a bone marrow biopsy/aspirate procedure may reduce anxiety during the procedure.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 19, 2024
• Est. primary completion date: December 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid System Neoplasm

Intervention

Procedure:
• Bone Marrow Aspiration
Undergo bone marrow aspiration/biopsy
• Bone Marrow Biopsy
Undergo bone marrow aspiration/biopsy
• Music Therapy
Listen to music

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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