Clinical trial NCT03681743: Virtual Reality vs. Standard-of-Care for Comfort During Minor Plastic Surgery Procedures in Children
Official title: A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort During Minor Plastic Surgery Procedures in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Minor Plastic Surgery
Keywords: Virtual Reality
Pain
Anxiety
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: BC Children's Hospital Foundation
name: BC Children's Hospital Research Institute
First posted: 2018-09-24
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Pain measured using the Faces Pain Scale - Revised.
timeFrame: Pain is reported by children immediately following completion of the minor plastic surgery procedure
Secondary outcomes:
measure: Anxiety using the Venham Situational Anxiety Score
timeFrame: Anxiety is reported by children immediately following completion of the minor plastic surgery procedure
measure: Patient Satisfaction determined by Global Rating Scale
timeFrame: Satisfaction questions are reported by children immediately following completion of the minor plastic surgery procedure
measure: Medication Dose
timeFrame: These will be recorded during the procedure and immediately following the procedure using the patient chart
measure: Timing
timeFrame: Documented immediately after patient and family given discharge instructions
measure: Patient Use of Virtual Reality in the Future by Yes/No Question
timeFrame: Reported by children immediately following completion of the minor plastic surgery procedure
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Ran D Goldman, MD
role: PRINCIPAL_INVESTIGATOR
References: