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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Hematologic Malignancy
• Intervention / Treatment: Other: Standard of Care; Other: Virtual Reality intervention

Detailed Description

This will be a randomized controlled trial comparing standard of care to standard of care + VR intervention for adult participants who have or are suspected of having a malignant hematologic disorder and are scheduled for an outpatient bone marrow biopsy (BMB) and/or bone marrow aspiration (BMA). Participants will be randomized 1:1. Participants will be risk stratified based on whether they are undergoing a biopsy for the first time or not.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Courtney Schepel; Phone Number: (980) 442-2327; Email: Courtney.Schepel@advocatehealth.org
• Study Contact Backup: Name: Cindy Varga, MD; Phone Number: 704-355-2000; Email: Cindy.Varga@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Levine Cancer Insitute
      • Principal Investigator: Cindy Varga, MD
      • Contact: Courtney Schepel; Phone Number: 980-442-2327; Email: Courtney.Schepel@advocatehealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard of Care	Other: Standard of Care; Standard of care for a bone marrow biopsy/bone marrow aspiration includes routine site-specific lidocaine anesthetic.
Other: Virtual Reality intervention and Standard of Care	Other: Standard of Care; Standard of care for a bone marrow biopsy/bone marrow aspiration includes routine site-specific lidocaine anesthetic.; Other: Virtual Reality intervention; Participants will wear the VR headset (Quest 3 by Meta) during your bone marrow procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single time point evaluation completed immediately following biopsy procedure	For each participant, the Numeric Rating Scale (NRS) score 24 hrs (-6 hrs/+12 hrs) 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 persisting pain.	Single time point evaluation completed 24 hours after biopsy procedure.
State Trait Anxiety Inventory Trait-5 Change Score	The State Trait Anxiety Inventory Trait-5 (STAIT-5) is a five-item assessment scored on a 4-point Likert scale (1-Not at all, 2-Somewhat, 3-Moderately So, 4-Very Much So) that captures the participants' current state of anxiety with higher scores indicating more anxiety. The five items are as follows: I feel upset, I feel frightened, I feel nervous, I am jittery, I feel confused. The total scores can range from 5 to 20 and the reduction and impact on participants' anxiety while using the Virtual Reality Headset will be based on the change from pre and post biopsy assessments.	Two time point evaluations completed immediately following and 24 hours after biopsy procedure.
Likelihood to Repeat	The likelihood of the participant being willing to complete a repeat bone marrow biopsy if deemed medically beneficial will be captured on a 5-point Likert scale immediately following the procedure. Participants will be asked to provide their response to: Please rate your agreement with having the bone marrow biopsy/ bone marrow aspirate procedure done again if deemed medically beneficial. Potential responses can be reported as 1-strongly Disagree, 2-Disagree, 3-Neutral/unsure, 4-Agree and 5-Strongly Agree.	Single time point evaluation completed 24 hours after biopsy procedure.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who discontinued study treatment due to adverse events	Specific to the treatment arm only, a binary variable will be determined for each participant indicating whether or not the subject discontinued use of the virtual reality headset due to adverse events (i.e., headache, neck pain, dizziness, seizures, eye strain or muscle twitching, or syncope).	Evaluation of discontinued study treatment is a periprocedural time point. Estimated time frame is less than 1 hour.

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Atrium Health Levine Cancer Institute
• Investigators: Principal Investigator: Cindy Varga, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: September 23, 2025
• First Submitted That Met QC Criteria: September 30, 2025
• First Posted (Actual): October 2, 2025

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Bone Marrow Biopsy; Virtual Reality Headset
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: IRB00136466; P30CA012197 (U.S. NIH Grant/Contract); ONC-MM-2407 (Other Identifier: Atrium Health)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No