Clinical trial · Interventional
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
NCT07203534CI-TRIAL-00119059recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard of Care | Other | — | UNRESOLVED |
| Virtual Reality intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Standard of Care
- interventionNames
- Other: Standard of Care
- type
- OTHER
- label
- Virtual Reality intervention and Standard of Care
- interventionNames
- Other: Standard of Care
- Other: Virtual Reality intervention
Primary outcomes (1)
- measure
- Numeric Rating Scale Pain Scores Immediately Post-biopsy
- timeFrame
- Single time point evaluation completed immediately following biopsy procedure
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.