Passive Music Intervention for the Reduction of Anxiety in Patients Undergoing Bone Marrow Aspiration and/or Biopsy
NCT ID: NCT06169267
Last Updated: 2026-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
113 participants
INTERVENTIONAL
2024-04-22
2026-06-15
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group I (no music)
Patients undergo standard of care bone marrow biopsy and/or aspiration.
Bone Marrow Aspiration
Undergo bone marrow aspiration/biopsy
Bone Marrow Biopsy
Undergo bone marrow aspiration/biopsy
Questionnaire Administration
Ancillary studies
Group II (listen to music)
Patients listen to music while undergoing standard of care bone marrow biopsy and/or aspiration.
Bone Marrow Aspiration
Undergo bone marrow aspiration/biopsy
Bone Marrow Biopsy
Undergo bone marrow aspiration/biopsy
Music Therapy
Listen to music
Questionnaire Administration
Ancillary studies
Interventions
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Bone Marrow Aspiration
Undergo bone marrow aspiration/biopsy
Bone Marrow Biopsy
Undergo bone marrow aspiration/biopsy
Music Therapy
Listen to music
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Monzr M Al Malki
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Other Identifiers
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NCI-2023-09975
Identifier Type: REGISTRY
Identifier Source: secondary_id
22502
Identifier Type: OTHER
Identifier Source: secondary_id
22502
Identifier Type: -
Identifier Source: org_study_id
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