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

Laceration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03681717
• Other study ID #: H17-02711
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: September 2018
• Source: University of British Columbia
• Contact: Ran D. Goldman, MD
• Phone: 604-875-2345
• Email: rgoldman[@]cw.bc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Laceration
• Lacerations

Intervention

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.

Locations

Country	Name	City	State
Canada	BC Children's Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Doctors of BC

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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