ONC-MM-2407: The Effect of Virtual Reality Headsets on Pain and Anxiety in the Peri and Post Bone Marrow Biopsy Period
Recruiting · NCT07203534 · Interventional (participants receive a specific treatment) · Lead sponsor: Wake Forest University Health Sciences
View the official record on ClinicalTrials.gov →Interventions studied
Standard of CareVirtual Reality intervention
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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.
Where it is running
1 location listed across 1 US state.
- Levine Cancer Insitute - Charlotte, North Carolina, United States