NCT06169267

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hematopoietic and Lymphoid System Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Bone Marrow Aspiration	Undergo bone marrow aspiration/biopsy
PROCEDURE	Bone Marrow Biopsy	Undergo bone marrow aspiration/biopsy
PROCEDURE	Music Therapy	Listen to music
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2024-04-22
• Primary completion: 2026-06-15
• Completion: 2026-06-15
• First posted: 2023-12-13
• Last updated: 2026-01-28

Locations

1 site across 1 country: United States