Randomized Controlled Trial of Virtual Reality
- Conditions
- Muscle Spasticity
- Interventions
- Device: Virtual Reality
- Registration Number
- NCT03521076
- Lead Sponsor
- Gillette Children's Specialty Healthcare
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 49
- Patients receiving botulinum toxin injections at Gillette Children's Specialty Healthcare
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Virtual Reality for distraction Virtual Reality 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.
- Primary Outcome Measures
Name Time Method The Faces Pain Scale - Revised (FPS-R) to assess intensity of pain during injections. 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 Outcome Measures
Name Time Method A series of visual analogue scales (VAS) to assess pain, anxiety, satisfaction with pain management, and perceived benefits of VR. 2 days A visual analogue scale (VAS) will be used to quantify multiple aspects of the treatment experience expected to be impacted by the use of VR. The VAS will be a 10 cm 0-100 scale and will assess the following: patient anxiety before, during and after the procedure; parent/caregiver anxiety before, during, and after the procedure; proportion of the treatment time spent thinking about pain; worst pain during treatment; satisfaction with pain management; and nausea during treatment. This will be done at both visits (VR and no-VR).
The Brief Pain Inventory (BPI) 2 days The Brief Pain Inventory (BPI) will provide a measure of pain interference in the previous week (i.e., the degree to which ongoing pain interferes with daily living). The BPI is a 10-item, 11-point scale (0 = does not interfere, 10 = completely interferes). The items include general activity, mood, mobility, normal work, relationships with other people, sleep, enjoyment of life, self-care, recreational activities, and social activities. Total score (sum of all 12 items combined; range 0-120) and average score (average item score; range 0-10) will be assessed.
The Dalhousie Pain Interview (DPI) 2 days The Dalhousie Pain Interview (DPI) will provide a measure of pain experience in the previous week, including pain frequency (number of pain episodes), intensity (rated 0-10) and duration (number of seconds or minutes in pain). The measure consists of 10 items and was designed explicitly as an interview/survey script.
Information collected from the medical record (e.g., medication use during procedure). 2 days Following the signing of a HIPPA release, the medical record will be accessed to obtain such information as: patient diagnosis, date of birth, ethnicity, number of botulinum toxin injections, muscles injected, patient weight, height, and temperature, heart rate, blood pressure and oxygen saturation during treatment, clinical description of the context of VR use; provider description of whether VR enhanced clinical care; reduction or avoidance of medication due to VR; total amounts of medications given (e.g., valium, nitrous oxide, opioids; mg/kg); and notation of patient side effects from VR. This will be done at both visits (VR and no-VR).
The Pain Opinion Questionnaire (POQ) 2 days The Pain Opinion Questionnaire (POQ) requires caregivers to respond to 5 questions in 3 separate sections regarding children with mild, moderate, and severe/profound intellectual and developmental disabilities. A description of the abilities and limitations of a typical individual with each level of impairment is provided in each section. The questions address 5 facets of pain: (a) the ability of the children to sense painful stimuli (Sensation), (b) how upset or distressed the children feel while in pain (Emotional Reaction), (c) how strongly the children react behaviorally to pain (Behavioral Reaction), (d) how much the children communicate their pain to others (Communication), and (e) how much pain the children suffer (Frequency). We are modifying the scale to require parents or caregivers to estimate whether they believe their child (not a hypothetical child) would experience that aspect of pain the "same as", "less than", or "more than" children without impairment.
Trial Locations
- Locations (1)
GilletteChildren's Specialty Healthcare
🇺🇸Saint Paul, Minnesota, United States