VR for Lac Repairs in Peds Emergency Department

NCT ID: NCT06516003

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-03-30

Brief Summary

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.

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

Conditions

Laceration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual Reality

Patients randomized to receive virtual reality goggles in addition to the standard of care.

Group Type: EXPERIMENTAL

Immersive Virtual Reality Goggles

Intervention Type: DEVICE

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.

Standard of Care

Patients that are randomized to receive the standard of care including other distraction techniques and child life specialist.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: BEHAVIORAL

Distraction techniques like tablet, phone, television, parent, child life specialist

Interventions

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.

Intervention Type: DEVICE

Standard of Care

Distraction techniques like tablet, phone, television, parent, child life specialist

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eastern Virginia Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Children's Hospital of the King's Daughters

Norfolk, Virginia, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

29-01-FB-0211

Identifier Type: -

Identifier Source: org_study_id