LacerationNCT03681717
Virtual Reality vs. Standard-of-Care for Comfort During Laceration Repair
A study testing Virtual Reality in people with Laceration, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Laceration
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2018to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
BC Children's Hospital
Vancouver, British Columbia, V6H 3N1
Ran D. Goldman, MD, 604-875-2345 ext. 7333, rgoldman@cw.bc.ca
Amir Behboudi, MD
About this study
Official title: 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.
- Conditions
- Laceration
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality, Pain, Anxiety
- Medical subject headings
- Lacerations, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Participants are distracted by wearing the virtual reality headset and watching a roller coaster app during laceration repair with sutures. Receives: Device: Virtual Reality |
| Control (Standard-of-Care) | No intervention | Participants are distracted with Standard-of-Care by doctors, nurses, nurse practitioners, child life specialists and/or parents. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pain is reported by children immediately following completion of the laceration repair
Secondary outcomes (5)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Documented immediately after patient and family given discharge paperwork
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start1 Feb 2018
- Primary completion31 Jan 2019 (estimated)
- Study completion31 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LacerationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Doctors of BC
- Responsible party
- Principal investigator, Ran Goldman, University of British Columbia
- Investigators
- Ran D. Goldman, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681717
- Sponsor's protocol ID
- H17-02711
- Status last verified
- Sep 2018
- First submitted
- 5 Jul 2018
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort During Laceration Repair
- ClinicalTrials.gov ID
- NCT03681717
- Acronym / sponsor ID
- H17-02711
- Conditions
- Laceration
- Keywords
- Virtual Reality, Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Doctors of BC
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Jan 2019 (estimated)
- Study completion
- 31 Jan 2019 (estimated)
- First posted
- 24 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Device: Virtual RealityParticipants are distracted by wearing the virtual reality headset and watching a roller coaster app during laceration repair with sutures. |
| Control (Standard-of-Care) | No intervention | –Participants are distracted with Standard-of-Care by doctors, nurses, nurse practitioners, child life specialists and/or parents. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityParticipants 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. | Device | Virtual Reality |
Primary outcome
Pain using the Faces Pain Scale - Revised.
Time frame: Pain is reported by children immediately following completion of the laceration repair
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.
5 secondary outcomes
Anxiety using the Venham Situational Anxiety Score
Time frame: Anxiety is reported by children immediately following completion of the laceration repair
Patient Satisfaction determined qualitatively by an open ended question
Time frame: Satisfaction question is reported by children immediately following completion of the laceration repair
Parent Satisfaction determined qualitatively by an open ended question
Time frame: Satisfaction question is reported by parents immediately following completion of the laceration repair
Medication Dose
Time frame: These will be recorded during the procedure and immediately following the procedure using the patient chart and nursing notes
Timing
Time frame: Documented immediately after patient and family given discharge paperwork
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ran D. Goldman, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Laceration, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ran D. Goldman, MD (604-875-2345 ext. 7333, rgoldman@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain using the Faces Pain Scale - Revised. (time frame: Pain is reported by children immediately following completion of the laceration repair). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2018.