Virtual Reality vs. Standard-of-Care for Comfort During Laceration Repair

A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort During Laceration Repair

Lacerations are a common reason for presentation to the Emergency Department and children needing laceration repair with sutures are experiencing pain and anxiety.

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 pharmacoanalgesia during a laceration repair procedure. Investigators will measure pain, anxiety, satisfaction, amount of analgesia and the length of procedure and compare between the two groups.

Study Overview

• Status: Unknown
• Conditions: Laceration
• Intervention / Treatment: Device: Virtual Reality

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

Contacts and Locations

• Study Contact: Name: Ran D. Goldman, MD; Phone Number: 7333 604-875-2345; Email: rgoldman@cw.bc.ca

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
      • Principal Investigator: Amir Behboudi, MD

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 - <17 years
• Arriving to the Emergency Department with a chief complaint of laceration
• The managing physician determines need for repair with suture
• 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)
• Triage category 1 (resuscitation)
• Facial features or injury prohibiting wearing VR goggles

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 laceration repair with sutures.	Device: Virtual Reality; Participants wear a Virtual Reality headset that consists of a ASUS phone and a ReTrack Utopia 360 VR 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, nurses, nurse practitioners, child life specialists and/or parents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain 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 laceration repair

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 laceration repair
Patient Satisfaction determined qualitatively by an open ended question	Satisfaction from the procedure is determined qualitatively. Children are asked "What is your opinion on how the procedure went?" Answers will be recorded in writing and be assessed for themes (similar words, positive or negative language).	Satisfaction question is reported by children immediately following completion of the laceration repair
Parent Satisfaction determined qualitatively by an open ended question	Satisfaction from the procedure is determined qualitatively. Parents are asked "What is your opinion on how the procedure went?" Answers will be recorded in writing and be assessed for themes (similar words, positive or negative language).	Satisfaction question is reported by parents immediately following completion of the laceration repair
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 and nursing notes
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 emergency department (given discharge paperwork).	Documented immediately after patient and family given discharge paperwork

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Doctors of BC
• Investigators: Principal Investigator: Ran D. Goldman, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Anticipated): January 31, 2019
• Study Completion (Anticipated): January 31, 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
• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations
• Other Study ID Numbers: H17-02711

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