Randomized Controlled Trial of Virtual Reality for Pain Management in a Specialty Rehabilitation Context
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- The Faces Pain Scale - Revised (FPS-R) to assess intensity of pain during injections.
Study Overview
Brief Summary
Measure pain and anxiety during a putative painful medical procedure (i.e., botulinum toxin injections) when Virtual Reality is employed compared to standard of care only using a Randomized Controlled Trial study design.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
Researcher #1 will break the blind and know which condition the participant is in. Researcher #1 will then be the one to video record the treatment session. Researcher #1 will leave the room immediately following the treatment intervention. Researcher #2 will enter the room and will support the patient, parent/caregiver, and provider in completing outcomes assessments.
Eligibility Criteria
- Ages
- 4 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients receiving botulinum toxin injections at Gillette Children's Specialty Healthcare
Exclusion Criteria
- •Patients who are fully anesthetized during their medical procedure
- •Non-English speaking parents/patients
- •Patients with history of motion sickness
- •Patients with epilepsy
- •Patients with a ventricular shunt
- •Patients who have surgery during the study time period
Arms & Interventions
Virtual Reality for distraction
The application of VR during the putative painful treatment (botulinum toxin injections) will provide a) active and engaging distraction during the procedure, and will b) block the view and auditory noise related to the procedure.
Intervention: Virtual Reality (Device)
Standard of Care
Patients will receive the standard of care for the putative painful treatment (botulinum toxin injections).
Outcomes
Primary Outcomes
The Faces Pain Scale - Revised (FPS-R) to assess intensity of pain during injections.
Time Frame: 2 days
The Faces Pain Scale - Revised (FPS-R) will be used to assess pain intensity before, during, and after the treatment session. The FPS-R is a self-report measure of pain intensity developed for children. This scale shows a serious of six faces depicting increasing intensity of pain expression. The FPS-R instructions orient the child to the series of faces and then ask the child to point to the face that shows how much they hurt right now. Each face corresponds to a numerical rating between 0 and 10 (0, 2, 4, 6, 8, and 10). This rating scale corresponds to the widely accepted 0-to-10 metric for pain. The "0" equals no pain and the "10" equals very much pain. The score is reported as a total score.
Secondary Outcomes
- A series of visual analogue scales (VAS) to assess pain, anxiety, satisfaction with pain management, and perceived benefits of VR.(2 days)
- The Brief Pain Inventory (BPI)(2 days)
- The Dalhousie Pain Interview (DPI)(2 days)
- Information collected from the medical record (e.g., medication use during procedure).(2 days)
- The Pain Opinion Questionnaire (POQ)(2 days)
Investigators
Chantel Burkitt
Clinical Scientist
Gillette Children's Specialty Healthcare