Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-01 @ 9:54 PM
Study NCT ID:
NCT03568292
Status:
SUSPENDED
Last Update Posted:
2025-11-17
First Post:
2018-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality in Reducing Pain and Anxiety in Cancer Participants Undergoing Painful Procedures
Sponsor:
University of Southern California
Organization:
Study Overview
Official Title:
Effects of Virtual Reality on Pain and Anxiety in Cancer Patients Undergoing Painful Procedures
Status:
SUSPENDED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Awaiting new cohort to open
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial studies how well virtual reality (VR) works in reducing pain and anxiety in cancer participants undergoing bone marrow biopsy or lumbar puncture. Virtual reality may impact pain and anxiety during and after the procedure.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the feasibility of VR in patients undergoing procedural intervention.
SECONDARY OBJECTIVES:
I. To estimate differences between the two arms in terms of pain and anxiety. II. To document any adverse events that could possibly be attributed to the VR intervention.
EXPLORATORY OBJECTIVES:
I. Explore the use of biomarkers as a tool to reflect the impact of intervention.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants undergo VR intervention peri-procedure (bone marrow biopsy or lumbar puncture) lasting until completion of the procedure.
ARM II: Participants receive standard of care during procedure (bone marrow biopsy or lumbar puncture).
I. To determine the feasibility of VR in patients undergoing procedural intervention.
SECONDARY OBJECTIVES:
I. To estimate differences between the two arms in terms of pain and anxiety. II. To document any adverse events that could possibly be attributed to the VR intervention.
EXPLORATORY OBJECTIVES:
I. Explore the use of biomarkers as a tool to reflect the impact of intervention.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants undergo VR intervention peri-procedure (bone marrow biopsy or lumbar puncture) lasting until completion of the procedure.
ARM II: Participants receive standard of care during procedure (bone marrow biopsy or lumbar puncture).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2018-00759 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 0S-17-10 | OTHER | USC / Norris Comprehensive Cancer Center | View | |
| P30CA014089 | NIH | None | https://reporter.nih.gov/quic… | View |