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

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

Recruiting
18 years and older
All
Phase 3

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Overview

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.

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)

Study details
    Hematopoietic and Lymphoid System Neoplasm

NCT06169267

City of Hope Medical Center

18 May 2024

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