Using music to reduce anxiety during bone marrow procedures
Phase III Intention to Treat Study of the Effect of Passive Music Intervention on Anxiety in Patients Undergoing Bone Marrow Aspiration and/or Biopsy
PHASE3 · City of Hope Medical Center · NCT06169267
This study is testing if listening to music during bone marrow procedures can help reduce anxiety and pain for patients.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center (other) |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT06169267 on ClinicalTrials.gov |
What this trial studies
This phase III trial investigates the impact of passive music intervention on anxiety levels in patients undergoing bone marrow aspiration and/or biopsy. Participants are randomized into two groups: one receiving standard care and the other listening to music during the procedure. The primary goal is to assess whether music can alleviate psychological distress, while secondary objectives include evaluating pain levels associated with anxiety. The study aims to develop an evidence-based music intervention protocol for future use.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with hematological conditions requiring a bone marrow biopsy or aspiration.
Not a fit: Patients scheduled for sedated procedures or those with hearing impairments may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could significantly reduce anxiety and pain for patients undergoing bone marrow procedures.
How similar studies have performed: Previous studies have shown that music therapy can effectively reduce anxiety in various medical settings, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (RECRUITING)
Study contacts
- Principal investigator: Monzr M Al Malki — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hematopoietic and Lymphoid System Neoplasm