VR for Lac Repairs in Peds Emergency Department

July 17, 2024 updated by: Eastern Virginia Medical School

Use of Immersive Virtual Reality for Laceration Repairs in the Pediatric Emergency Department

The goal of the clinical trial is to compare virtual reality to standard of care for laceration repairs in the pediatric emergency department. The main question it aims to answer is:

-Does virtual reality decrease pain and anxiety scores compared to standard of care for laceration repairs in the pediatric emergency department?

Participants who meet the age and other inclusion criteria will be enrolled by research staff. They will complete a brief paper survey along with their guardians and the provider doing the laceration repair. The surveys will be completed after the laceration repair is finished.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be a randomized pragmatic study for all patients ages 6-17 years with simple lacerations. Simple lacerations will be defined as lacerations within the scope of pediatric emergency medicine providers AND not requiring sedation or operative intervention. Subjects will be identified by the Emergency Department staff for enrollment. The goal number of enrolled participants will be 480, including 240 patients randomized into two groups, 120 per group, and 240 parents/guardians. The Emergency Department accepted to participate in this study and ED providers will complete the provider's survey. After signing the consent and assent form when appropriate, the patients will be randomized to either receive the standard of care or standard or care with immersive virtual reality goggles. Consent and assent will be obtained in the patient rooms within the emergency department. The standard of care shall be defined to include any of the following: local analgesia (topical LET and/ or subcutaneous lidocaine), oral or intranasal midazolam, distraction, Child Life Staff, or physical holding. Because each of the aforementioned interventions may vary between patients, it cannot be truly standardized; hence, this will be considered a pragmatic study. Patients randomized to the VR arm will receive the other standard procedures as well with VR goggles as an adjunct. Exclusion criteria include a history of epilepsy, visual or hearing impairment, or intellectual disability that would preclude use of VR goggles as determined by the guardian. Additionally, any lacerations around the eyes, eyebrows, and nose will be excluded as well as patients requiring sedation. Non-English speaking patients will be excluded as well. Hand lacerations will not be excluded.

Participants will be identified by ED staff following evaluation of the laceration. The ED staff will be given a flowchart with eligibility criteria. All interested participants who meet eligibility criteria will be consented. A research team member will obtain consent from parents or guardians by providing and reviewing the consent form (see Subject Consent Form). For patients who are between 8 and 17 years of age, a research team member will obtain assent by providing and reviewing the assent form (see Subject Assent Form). Consent and assent will be obtained in the patient's ED room.

Patients will be separated into groups age 6-11 and 12-17. Patients will be randomized via a selection of a sealed envelope which will contain instructions for use of the VR goggles. The goggles utilized will be Lenovo Mirage Solo with DayDream, which are standalone VR headset with Worldsense Body Tracking. Research staff will coach the child on age-appropriate games, as previously determined by Lenovo.

The goggles will be cleansed with Oxivir Tb disinfectant wipes after each use and allowed to dry in room air prior to next use. Education will be provided to all ED providers on the proper cleansing protocol for the VR goggles (Figure 4). The disinfectant protocol will be available for all users during the study, and has been approved by the director of Infection Control at Children's Hospital of the King's Daughters.

Following the laceration repair, the patient, guardian and health care provider will be surveyed (Figure 1, 2, and 3) on paper surveys. The survey includes Likert-type scale questions, binary questions as well as incorporates the Wong Baker Faces Pain Scale and Children's Fear Scale. The duration of the procedure will be recorded by the healthcare provider who completed the laceration repair. Time of procedure will be defined as from the time of irrigation to wound dressing. Patients and parents will both be filling out their own individual surveys. The parent should complete the survey first before the child should the child need assistance with completion. Patients and parents may decline to participate in any survey at any time

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Children's Hospital of The King's Daughters

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Simple lacerations that do not require surgical subspecialty repair or moderate or deep sedation
  • Hand lacerations
  • Laceration that required stitches

Exclusion Criteria:

  • less than 6 years old or greater than 17 years old
  • Non english speaking
  • Visual or hearing impairment
  • Epilepsy
  • Lacerations to forehead, nose, or cheeks where goggles cover
  • Intellectual disability that precludes participation as determined by guardian

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality
Patients randomized to receive virtual reality goggles in addition to the standard of care.
Device: Immersive Virtual Reality Goggles
Immersive Virtual Reality goggles are a head mounted device placed over a patient's head and eyes that allows them to play in a virtual reality game.
Active Comparator: Standard of Care
Patients that are randomized to receive the standard of care including other distraction techniques and child life specialist.
Behavioral: Standard of Care
Distraction techniques like tablet, phone, television, parent, child life specialist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: Assessed immediately after intervention
Using Wong Baker Faces Pain Scale
Assessed immediately after intervention
Fear Score
Time Frame: Assessed immediately after intervention
Using Children's Fear Score
Assessed immediately after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction of procedure
Time Frame: Assessed immediately after intervention
Assessed by Likert- type scale question
Assessed immediately after intervention
Side Effects
Time Frame: Assessed immediately after intervention
nausea, vomiting, dizziness, headache, other
Assessed immediately after intervention
Duration of procedure
Time Frame: Assessed immediately after intervention
Five minute intervals up to 25 minutes
Assessed immediately after intervention
Future Use
Time Frame: Assessed immediately after intervention
Would they recommend use of VR for same procedure again
Assessed immediately after intervention
Physical Holding
Time Frame: Assessed immediately after intervention
Did patient need to be held for the procedure
Assessed immediately after intervention
Anxiolytic Use
Time Frame: Assessed immediately after intervention
Did patient need anxiolytics for the procedure
Assessed immediately after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Virginia Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 17, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29-01-FB-0211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not planning to share data with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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