A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort During Minor Plastic Surgery Procedures in Children
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Minor Plastic Surgery
- Sponsor
- University of British Columbia
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Pain measured using the Faces Pain Scale - Revised.
- Last Updated
- 7 years ago
Overview
Brief Summary
Children often experience pain and anxiety during minor medical procedures. In addition to pain medication, distraction may help children cope with the pain. This may include interacting with books, TV, toys or videogames.
Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain.
This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care in addition to local anesthetics during minor painful procedure in the Plastic Surgery clinic. Pain, anxiety and satisfaction will be measured as well as the amount of analgesics used and the timing of the procedure. Outcome measures will be compared between the two groups.
Investigators
Ran Goldman
Professor and Co-head of the Division of Clinical Pharmacology, Division of Emergency Medicine, Department of Pediatrics; Investigator, BC Children's Hospital
University of British Columbia
Eligibility Criteria
Inclusion Criteria
- •Children age 6 to \< 17 years
- •Patients scheduled for minor elective plastic surgery procedure
- •Parents will sign a consent form and children will sign an assent form
Exclusion Criteria
- •Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay)
- •Facial features or injury prohibiting wearing the VR goggles
- •Procedure in the face, where the VR system may interfere with Plastic Surgeon work
Outcomes
Primary Outcomes
Pain measured using the Faces Pain Scale - Revised.
Time Frame: Pain is reported by children immediately following completion of the minor plastic surgery procedure
Level of pain as reported by children using Faces Pain Scale - Revised. The scale includes six faces that represent progressively more intense features of pain. Children point to the face that best represents their current level of pain. The minimum score is 0 (representing least pain) and the maximum score is 10 (representing greater pain). The scale increase in increments of 2.
Secondary Outcomes
- Anxiety using the Venham Situational Anxiety Score(Anxiety is reported by children immediately following completion of the minor plastic surgery procedure)
- Patient Use of Virtual Reality in the Future by Yes/No Question(Reported by children immediately following completion of the minor plastic surgery procedure)
- Patient Satisfaction determined by Global Rating Scale(Satisfaction questions are reported by children immediately following completion of the minor plastic surgery procedure)
- Timing(Documented immediately after patient and family given discharge instructions)
- Medication Dose(These will be recorded during the procedure and immediately following the procedure using the patient chart)