Status:
NOT_YET_RECRUITING
ONC-MM-2407: The Effect of Virtual Reality Headsets on Pain and Anxiety in the Peri and Post Bone Marrow Biopsy Period
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Atrium Health Levine Cancer Institute
Conditions:
Hematologic Malignancy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this research study is to see if a virtual reality (VR) headset is useful in reducing physical discomfort and anxiety experienced by patients who are scheduled to undergo a bone marrow ...
Detailed Description
This will be a randomized controlled trial comparing standard of care to standard of care + VR intervention for adult participants who have or are suspected of having a malignant hematologic disorder ...
Eligibility Criteria
Inclusion
- Ability to understand and willingness to sign an IRB-approved informed consent directly.
- Must be 18 years or older at time of consent.
- Scheduled for an outpatient bone marrow biopsy (BMB) and/or bone marrow aspiration (BMA). Note that this does not need to be the participant's first BMB/BMA.
- Participant should be suspected of or being diagnosed with a malignant hematologic disease (i.e., Acute or chronic leukemia, lymphoma, clonal plasma cell disorder, etc.) per the investigator.
- Ability to read and understand the English language.
- As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study
Exclusion
- Participant is prescribed analgesics or anxiolytics for the purpose of reducing pain or anxiety prior to the procedure.
- Participant with known intolerance to using virtual reality devices, significant motion sickness, history of seizures, history of vestibular disorders, or heart conditions (unstable angina, recent myocardial infarction within the last 3 months, decompensated heart failure, uncontrolled arrhythmias-ventricular tachycardia, a fibrillation with rapid ventricular rate), history of postural orthostatic tachycardia syndrome (POTS) per participant report.
- Participants with pacemakers, defibrillators, hearing aid, or other implanted medical device. The Meta Quest device contains magnets and components that emit magnetic/electromagnetic fields which could affect the operation of nearby electronics and medical devices.
- Planned to undergo the bone marrow biopsy/bone marrow aspiration via Interventional Radiology or as an inpatient admission.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT07203534
Start Date
January 1 2026
End Date
February 1 2028
Last Update
December 18 2025
Active Locations (1)
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1
Levine Cancer Insitute
Charlotte, North Carolina, United States, 28204