Malignant Neoplasm
Conditions
Brief summary
This trial studies how well virtual reality (VR) works in reducing pain and anxiety in cancer participants undergoing bone marrow biopsy or lumbar puncture. Virtual reality may impact pain and anxiety during and after the procedure.
Detailed description
PRIMARY OBJECTIVES: I. To determine the feasibility of VR in patients undergoing procedural intervention. SECONDARY OBJECTIVES: I. To estimate differences between the two arms in terms of pain and anxiety. II. To document any adverse events that could possibly be attributed to the VR intervention. EXPLORATORY OBJECTIVES: I. Explore the use of biomarkers as a tool to reflect the impact of intervention. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants undergo VR intervention peri-procedure (bone marrow biopsy or lumbar puncture) lasting until completion of the procedure. ARM II: Participants receive standard of care during procedure (bone marrow biopsy or lumbar puncture).
Interventions
OTHERBest Practice
Receive standard of care
OTHERLaboratory Biomarker Analysis
Correlative studies
DEVICEOculus Rift Headset
Subject wears headset for virtual reality intervention during bone marrow biopsy or lumbar puncture procedure
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
University of Southern California
National Cancer Institute (NCI)
Virtually Strong, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patient has been diagnosed with any cancer * Patient is currently hospitalized and receiving treatment for a primary or secondary cancer at University of Southern California (USC) Norris Comprehensive Cancer Center and Hospital * Patient is undergoing a bone marrow biopsy or lumbar puncture
Exclusion criteria
* Inability to sign informed assent and/or consent * Patient with an underlying diagnosis of epilepsy, dementia, Parkinson?s disease, primary central nervous system malignancy, brain metastasis, underlying inflammatory or infectious central nervous system disorder, inner ear infection, history of vertigo, baseline visual or hearing impairment, macular degeneration, untreated glaucoma, implantable medical devices or any medical condition that investigator deems contraindicated * Patient with an underlying chronic pain disorder, anxiety disorder, depressive disorder, or other psychiatric illness unspecified * Patient with active Clostridium difficile infection * Patient on any acute (within last \< 24 hour \[hr\]) or chronic pain medication (opioid, nonsteroidal anti-inflammatory drug \[NSAID\], steroid) * Patient on chronic steroids \> 10 mg prednisone equivalent daily or other immunosuppressant \> 1 week * Patient who is post bone marrow transplant * Patient with a body mass index (BMI) \> 35
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain as assessed according to a visual analog scale (VAS) | Up to 1 year | A visual analogue pain scale is a validated pain measure. A 10 centimeter horizontal line with a 0 (no pain) on the far left and 10 (worst possible pain) on the far right. Participants rate pain intensity by drawing a mark on the line. Pain intensity is obtained by measuring from the 0 to the participant's mark on the line, yielding a score from 0 to 10. |
| Anxiety | Up to 1 year | Will be assessed by the State-Trait Anxiety Inventory. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJacek Pinski, MD
University of Southern California
Outcome results
None listed