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

Study Overview
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Brief Summary
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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.

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

Conditions
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Laceration

Intervention / Treatment
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* Device: Virtual Reality


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality<br>Participants are distracted by wearing the virtual reality headset and watching a roller coaster app during laceration repair with sutures. | Device: Virtual Reality<br>* 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.<br>|
| No Intervention: Control (Standard-of-Care)<br>Participants are distracted with Standard-of-Care by doctors, nurses, nurse practitioners, child life specialists and/or parents. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Pain, Anxiety