Virtual reality headsets to reduce pain and anxiety during bone marrow biopsy

The Effect of Virtual Reality Headsets on Pain and Anxiety in the Peri and Post Bone Marrow Biopsy Period

This will try a virtual reality headset to see if it reduces pain and anxiety for adults having an outpatient bone marrow biopsy or aspiration.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Wake Forest University Health Sciences (Academic / other)
• Locations: 1 site (Charlotte, North Carolina)
• Trial ID: NCT07203534 on ClinicalTrials.gov

What this trial studies

This is a randomized, controlled trial that compares standard care alone to standard care plus a virtual reality (VR) headset for adult patients with suspected or confirmed malignant hematologic disorders undergoing outpatient bone marrow biopsy or aspiration. Participants are randomized 1:1 and risk-stratified by whether they are having their first biopsy. The intervention group uses a VR headset in the peri-procedural period while outcomes such as pain and anxiety are measured before, during, and after the procedure using standard scales. Patients on pre-procedure analgesics or anxiolytics and those with known VR intolerance or seizure history are excluded.

Who should consider this trial

Good fit: Adults (18+) who can read English, are able to give informed consent, are suspected of or diagnosed with a malignant hematologic disorder, and are scheduled for an outpatient bone marrow biopsy or aspiration (and not already on pre-procedure analgesic or anxiolytic medications) are ideal candidates.

Not a fit: Patients who are receiving pre-procedure analgesics or anxiolytics, have significant motion sickness or known intolerance to VR, a history of seizures, are non-English speakers, or cannot attend the outpatient site are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the VR headset could reduce peri- and post-procedure pain and anxiety and improve the overall biopsy experience without adding medications.

How similar studies have performed: Prior trials of VR for procedural pain and anxiety in other medical settings have shown modest reductions in pain and anxiety, so this approach has some supporting but mixed evidence.

Eligibility criteria

Inclusion Criteria:

1. Ability to understand and willingness to sign an IRB-approved informed consent directly.
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:

1. Participant is prescribed analgesics or anxiolytics for the purpose of reducing pain or anxiety prior to the procedure.
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.

Where this trial is running

Charlotte, North Carolina

• Levine Cancer Insitute — Charlotte, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Cindy Varga, MD — Wake Forest University Health Sciences
• Study coordinator: Courtney Schepel

Conditions Hematologic Malignancy; Bone Marrow Biopsy; Virtual Reality Headset