Recruiting

VR with BMB & BMA

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07203534

Conditions

Hematologic Malignancy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard of Care

Virtual Reality intervention

Study Details

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 biopsy (BMB) and/or bone marrow aspiration (BMA).

Conditions

Hematologic Malignancy

Study ID

NCT07203534

Start date

Jan 23, 2026

Status verified date

Jul, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Standard of Care

other: Virtual Reality intervention and Standard of Care

Interventions

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.

Primary outcome measure

  • Numeric Rating Scale Pain Scores Immediately Post-biopsy [ Time Frame: Single time point evaluation completed immediately following biopsy procedure ]

Central Contacts and Locations

Locations

Levine Cancer Insitute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Principal Investigator:

Cindy Varga, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Bone Marrow Biopsy
  • Virtual Reality Headset

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-23.