Virtual Reality vs. Standard-of-Care for Comfort During Minor Plastic Surgery Procedures in Children

A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort During Minor Plastic Surgery Procedures in Children

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.

Study Overview

• Status: Unknown
• Conditions: Minor Plastic Surgery
• Intervention / Treatment: Device: Virtual Reality

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • Recruiting
      • BC Children's Hospital
      • Contact: Ran D Goldman, MD; Phone Number: 7333 604-875-2345; Email: rgoldman@cw.bc.ca
      • Sub-Investigator: Amir Behboudi, MD
      • Sub-Investigator: Jugpal S Arneja, MD
      • Sub-Investigator: Paul GB Clerc, BKin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality; Participants are distracted by wearing the virtual reality headset and watching a roller coaster app during an IV start.	Device: Virtual Reality; Participants wear a Virtual Reality headset that consists of a ASUS phone and a VOX+ Z3 3D Virtual Reality Headset. The phone runs the VR Roller Coaster app to produce the virtual environment.
No Intervention: Control (Standard-of-Care); Participants are distracted with Standard-of-Care by doctors and/or parents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain measured using the Faces Pain Scale - Revised.	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.	Pain is reported by children immediately following completion of the minor plastic surgery procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Dose	How much topical or local anesthetics are used and when they are used (24 hour time); how much sedatives are used and when they are used (24 hour time); how much analgesics are used and when they are used (24 hour time).	These will be recorded during the procedure and immediately following the procedure using the patient chart
Anxiety using the Venham Situational Anxiety Score	Level of Situational Anxiety as reported by children using the Venham Situational Anxiety Score. This scale includes 8 sets of 2 images of children which represent differing levels of anxiety. Children point to the child that best represents them in that instance. In each set of 2 images of children, one represents greater anxiety (scored as 1) and one represents lesser anxiety (scored as 0). The points from each set of images are totaled. The minimum score is 0 (least anxious) and maximum score is 8 (most anxious).	Anxiety is reported by children immediately following completion of the minor plastic surgery procedure
Patient Satisfaction determined by Global Rating Scale	Satisfaction from the procedure is determined by asking 4 questions on a global rating scale. This scale goes from 0-10 where 0 represents "not very much" and 10 represents "very much." Questions are developed from previous virtual reality research. "Overall, how satisfied are you with pain management during plastic surgery?" "Overall, how satisfied are you with anxiety management during plastic surgery?" "To what extent did you feel like you went into the virtual world?" "How much fun did you have while playing in the virtual world?" These questions will be analyzed individually not summed.	Satisfaction questions are reported by children immediately following completion of the minor plastic surgery procedure
Timing	Time in minutes from readiness for procedure (availability of child, staff and equipment) until completion of procedure (physician does not need to touch the patient anymore) and until discharged from the plastic surgery clinic department (given discharge instructions).	Documented immediately after patient and family given discharge instructions
Patient Use of Virtual Reality in the Future by Yes/No Question	Patients were asked if they would use virtual reality in the future for a similar procedure.	Reported by children immediately following completion of the minor plastic surgery procedure

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: BC Children's Hospital Research Institute; BC Children's Hospital Foundation
• Investigators: Principal Investigator: Ran D Goldman, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2018
• Primary Completion (Anticipated): May 9, 2019
• Study Completion (Anticipated): May 9, 2019

Study Registration Dates

• First Submitted: July 5, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): September 24, 2018
• Last Update Submitted That Met QC Criteria: September 20, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Virtual Reality
• Other Study ID Numbers: H18-01150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No