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NCT06169267 | RECRUITING | Hematopoietic and Lymphoid System Neoplasm

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

City of Hope Medical Center

Brief 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.

Condition or disease

Hematopoietic and Lymphoid System Neoplasm

Intervention/treatment

Bone Marrow Aspiration

Bone Marrow Biopsy

Music Therapy

Questionnaire Administration

Phase

PHASE3

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
Estimated Enrollment : 110 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
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
Actual Study Start Date : 2024-04-22
Estimated Primary Completion Date : 2025-06-19
Estimated Study Completion Date : 2025-06-19

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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)
Passive Music Intervention for the Reduction of Anxiety in Patients Undergoing Bone Marrow Aspiration and/or Biopsy

Location Details

NCT06169267

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Locations

RECRUITING

United States, California

City of Hope Medical Center

Duarte, California, United States, 91010