Effects of Virtual Reality on Pain and Anxiety in Cancer Patients Undergoing Painful Procedures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Anxiety
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Arm I: Virtual Reality
Participants receive the VR intervention during bone marrow biopsy or lumbar puncture lasting until completion of the procedure. Participants will be trained to use VR equipment prior to the bone marrow biopsy or lumbar puncture. The headset will cover both eyes with a strap along the back to hold the headset in place. The headset will be attached by a wire to a laptop which will power the headset and provide content. A remote control will be available for assistance in setting up or stopping the content in the case of an event. The VR content will consist of meditation and relaxing techniques through visual and auditory input which can last up to one hour. There will be minimal stimulatory effort to decrease excess movement for the procedure.
Intervention: Laboratory Biomarker Analysis (Other)
Arm I: Virtual Reality
Participants receive the VR intervention during bone marrow biopsy or lumbar puncture lasting until completion of the procedure. Participants will be trained to use VR equipment prior to the bone marrow biopsy or lumbar puncture. The headset will cover both eyes with a strap along the back to hold the headset in place. The headset will be attached by a wire to a laptop which will power the headset and provide content. A remote control will be available for assistance in setting up or stopping the content in the case of an event. The VR content will consist of meditation and relaxing techniques through visual and auditory input which can last up to one hour. There will be minimal stimulatory effort to decrease excess movement for the procedure.
Intervention: Oculus Rift Headset (Device)
Arm I: Virtual Reality
Participants receive the VR intervention during bone marrow biopsy or lumbar puncture lasting until completion of the procedure. Participants will be trained to use VR equipment prior to the bone marrow biopsy or lumbar puncture. The headset will cover both eyes with a strap along the back to hold the headset in place. The headset will be attached by a wire to a laptop which will power the headset and provide content. A remote control will be available for assistance in setting up or stopping the content in the case of an event. The VR content will consist of meditation and relaxing techniques through visual and auditory input which can last up to one hour. There will be minimal stimulatory effort to decrease excess movement for the procedure.
Intervention: Questionnaire Administration (Other)
Arm II: No Virtual Reality
Participants receive standard of care during bone marrow biopsy or lumbar puncture.
Intervention: Best Practice (Other)
Arm II: No Virtual Reality
Participants receive standard of care during bone marrow biopsy or lumbar puncture.
Intervention: Questionnaire Administration (Other)
Arm II: No Virtual Reality
Participants receive standard of care during bone marrow biopsy or lumbar puncture.
Intervention: Laboratory Biomarker Analysis (Other)
Outcomes
Primary Outcomes
Anxiety
Time Frame: Up to 1 year
Will be assessed by the State-Trait Anxiety Inventory.
Pain as assessed according to a visual analog scale (VAS)
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported