Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2026-01-07 @ 8:34 PM
Study NCT ID:
NCT06169267
Status:
RECRUITING
Last Update Posted:
2025-07-04
First Post:
2023-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Passive Music Intervention for the Reduction of Anxiety in Patients Undergoing Bone Marrow Aspiration and/or Biopsy
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-09975 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 22502 | OTHER | City of Hope Medical Center | View | |
| P30CA033572 | NIH | None | https://reporter.nih.gov/quic… | View |