Hematologic MalignancyNCT07203534
ONC-MM-2407: The Effect of Virtual Reality Headsets on Pain and Anxiety in the Peri and Post Bone Marrow Biopsy Period
A study testing Virtual Reality intervention in people with Hematologic Malignancy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- Virtual Reality intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Levine Cancer Insitute
Charlotte, North Carolina, 28204
Courtney Schepel, 980-442-2327, Courtney.Schepel@advocatehealth.org
Cindy Varga, MD
About this study
Official title: 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).
Read the 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.
- Conditions
- Hematologic Malignancy
- Being tested
- Standard of Care, Virtual Reality intervention
- Keywords
- Bone Marrow Biopsy, Virtual Reality Headset
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Standard of care for a bone marrow biopsy/bone marrow aspiration includes routine site-specific lidocaine anesthetic.
Virtual Reality interventionOther
Participants will wear the VR headset (Quest 3 by Meta) during your bone marrow procedure.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | Not described Receives: Other: Standard of Care |
| Virtual Reality intervention and Standard of Care | Other | Not described Receives: Other: Standard of Care; Other: Virtual Reality intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single time point evaluation completed immediately following biopsy procedure
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Single time point evaluation completed 24 hours after biopsy procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start23 Jan 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Cindy Varga, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203534
- Sponsor's protocol ID
- IRB00136466
- Other IDs
- ONC-MM-2407, P30CA012197
- Status last verified
- Jul 2026
- First submitted
- 23 Sep 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Headsets on Pain and Anxiety in the Peri and Post Bone Marrow Biopsy Period
- ClinicalTrials.gov ID
- NCT07203534
- Acronym / sponsor ID
- IRB00136466
- Conditions
- Hematologic Malignancy
- Keywords
- Bone Marrow Biopsy, Virtual Reality Headset
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute, National Cancer Institute (NCI)
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Other: Standard of Care |
| Virtual Reality intervention and Standard of Care | Other | Other: Standard of Care, Other: Virtual Reality intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareStandard of care for a bone marrow biopsy/bone marrow aspiration includes routine site-specific lidocaine anesthetic. | Other | Standard of Care, Virtual Reality intervention and Standard of Care |
| Virtual Reality interventionParticipants will wear the VR headset (Quest 3 by Meta) during your bone marrow procedure. | Other | Virtual Reality intervention and Standard of Care |
Primary outcome
Numeric Rating Scale Pain Scores Immediately Post-biopsy
Time frame: Single time point evaluation completed immediately following biopsy procedure
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.
3 secondary outcomes
Single time point evaluation completed immediately following biopsy procedure
Time frame: Single time point evaluation completed 24 hours after biopsy procedure.
State Trait Anxiety Inventory Trait-5 Change Score
Time frame: Two time point evaluations completed immediately following and 24 hours after biopsy procedure.
Likelihood to Repeat
Time frame: Single time point evaluation completed 24 hours after biopsy procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cindy Varga, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality intervention in people with Hematologic Malignancy, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Courtney Schepel ((980) 442-2327, Courtney.Schepel@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale Pain Scores Immediately Post-biopsy (time frame: Single time point evaluation completed immediately following biopsy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.