ONC-MM-2407: The Effect of Virtual Reality Headsets on Pain and Anxiety in the Peri and Post Bone Marrow Biopsy Period

NCT07203534 | Recruiting DMC

• 3 other identifiers: IRB00136466ONC-MM-2407P30CA012197
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Keywords

Bone Marrow Biopsy; Virtual Reality Headset

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale Pain Scores Immediately Post-biopsy

  For each participant, the Numeric Rating Scale (NRS) score immediately post-biopsy will be captured indicating the participants' severity of pain. The score for each participant will be categorized into 6 ordinal categories (0 No Pain, 1-2 Very Mild, 3-4 Mild, 5-6 Moderate, 7-8 Severe, 9-10 Unbearable) and used to assess if those using the Virtual Reality Headset during the procedure experienced less overall pain immediately following the bone marrow biopsy.

  Single time point evaluation completed immediately following biopsy procedure

Secondary Outcomes (3)

• Single time point evaluation completed immediately following biopsy procedure

  Single time point evaluation completed 24 hours after biopsy procedure.

• State Trait Anxiety Inventory Trait-5 Change Score

  Two time point evaluations completed immediately following and 24 hours after biopsy procedure.

• Likelihood to Repeat

  Single time point evaluation completed 24 hours after biopsy procedure.

Other Outcomes (1)

• Number of participants who discontinued study treatment due to adverse events

  Evaluation of discontinued study treatment is a periprocedural time point. Estimated time frame is less than 1 hour.

Study Arms (2)

Standard of Care

OTHER

Other: Standard of Care

Virtual Reality intervention and Standard of Care

OTHER

Other: Standard of Care; Other: Virtual Reality intervention

Interventions

Standard of Care OTHER

Standard of care for a bone marrow biopsy/bone marrow aspiration includes routine site-specific lidocaine anesthetic.

Standard of Care; Virtual Reality intervention and Standard of Care

Virtual Reality intervention OTHER

Participants will wear the VR headset (Quest 3 by Meta) during your bone marrow procedure.

Virtual Reality intervention and Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Atrium Health Levine Cancer Institute: collaborator

Study Sites (1)

Levine Cancer Insitute

Charlotte, North Carolina, 28204, United States

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Cindy Varga, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Courtney Schepel

CONTACT

(980) 442-2327; Courtney.Schepel@advocatehealth.org

Cindy Varga, MD

CONTACT

704-355-2000; Cindy.Varga@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 2, 2025
• Study Start: January 23, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

US (1)