ONC-MM-2407: The Effect of Virtual Reality Headsets on Pain and Anxiety in the Peri and Post Bone Marrow Biopsy Period
NCT ID: NCT07203534
Last Updated: 2025-12-18
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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NOT_YET_RECRUITING
NA
160 participants
INTERVENTIONAL
2026-01-31
2028-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Standard of Care
Standard of Care
Standard of care for a bone marrow biopsy/bone marrow aspiration includes routine site-specific lidocaine anesthetic.
Virtual Reality intervention and Standard of Care
Standard of Care
Standard of care for a bone marrow biopsy/bone marrow aspiration includes routine site-specific lidocaine anesthetic.
Virtual Reality intervention
Participants will wear the VR headset (Quest 3 by Meta) during your bone marrow procedure.
Interventions
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Standard of Care
Standard of care for a bone marrow biopsy/bone marrow aspiration includes routine site-specific lidocaine anesthetic.
Virtual Reality intervention
Participants will wear the VR headset (Quest 3 by Meta) during your bone marrow procedure.
Eligibility Criteria
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Inclusion Criteria
2. Must be 18 years or older at time of consent.
3. 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.
4. 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.
5. Ability to read and understand the English language.
6. 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 Criteria
2. 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.
3. 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.
4. Planned to undergo the bone marrow biopsy/bone marrow aspiration via Interventional Radiology or as an inpatient admission.
18 Years
ALL
No
Sponsors
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Atrium Health Levine Cancer Institute
OTHER
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Cindy Varga, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Levine Cancer Insitute
Charlotte, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Courtney Schepel
Role: primary
Other Identifiers
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ONC-MM-2407
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00136466
Identifier Type: -
Identifier Source: org_study_id