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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: Courtney.Schepel@advocatehealth.org
• Phone: (980) 442-2327

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.