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

Primary Purpose

Laceration

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Laceration focused on measuring Virtual Reality, Pain, Anxiety

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BC Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality

Control (Standard-of-Care)

Arm Description

Participants are distracted by wearing the virtual reality headset and watching a roller coaster app during laceration repair with sutures.

Participants are distracted with Standard-of-Care by doctors, nurses, nurse practitioners, child life specialists and/or parents.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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).
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).
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).

Full Information

First Posted
July 5, 2018
Last Updated
September 20, 2018
Sponsor
University of British Columbia
Collaborators
Doctors of BC
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1. Study Identification

Unique Protocol Identification Number
NCT03681717
Brief Title
Virtual Reality vs. Standard-of-Care for Comfort During Laceration Repair
Official Title
A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort During Laceration Repair
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Anticipated)
Study Completion Date
January 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Doctors of BC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laceration
Keywords
Virtual Reality, Pain, Anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
Participants are distracted by wearing the virtual reality headset and watching a roller coaster app during laceration repair with sutures.
Arm Title
Control (Standard-of-Care)
Arm Type
No Intervention
Arm Description
Participants are distracted with Standard-of-Care by doctors, nurses, nurse practitioners, child life specialists and/or parents.
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain using the Faces Pain Scale - Revised.
Description
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.
Time Frame
Pain is reported by children immediately following completion of the laceration repair
Secondary Outcome Measure Information:
Title
Anxiety using the Venham Situational Anxiety Score
Description
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).
Time Frame
Anxiety is reported by children immediately following completion of the laceration repair
Title
Patient Satisfaction determined qualitatively by an open ended question
Description
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).
Time Frame
Satisfaction question is reported by children immediately following completion of the laceration repair
Title
Parent Satisfaction determined qualitatively by an open ended question
Description
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).
Time Frame
Satisfaction question is reported by parents immediately following completion of the laceration repair
Title
Medication Dose
Description
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).
Time Frame
These will be recorded during the procedure and immediately following the procedure using the patient chart and nursing notes
Title
Timing
Description
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).
Time Frame
Documented immediately after patient and family given discharge paperwork

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ran D. Goldman, MD
Phone
604-875-2345
Ext
7333
Email
rgoldman@cw.bc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ran D. Goldman, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran D. Goldman, MD
Phone
604-875-2345
Ext
7333
Email
rgoldman@cw.bc.ca
First Name & Middle Initial & Last Name & Degree
Amir Behboudi, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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