Virtual Reality During Procedures in Pediatric Patients

NCT ID: NCT03686176

Last Updated: 2020-08-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-05
• Study Completion Date: 2020-03-30

Brief Summary

This stratified, randomized, controlled trial compared coping and distress between child life supported virtual reality engagement and child life support during painful procedures in the pediatric emergency department.

Detailed Description

Pediatric emergency rooms and hospitals are anxiety provoking and often painful places for pediatric patients and families. Children of all ages present to the Johns Hopkins emergency room and are admitted to the hospital for a wide range of medical conditions, many of which require medical interventions. Many of these interventions are the source of anxiety and pain, including burn debridement or dressing changes, laceration repair, or intravenous (IV) line placement. The standard of care to reduce pain and improve coping during pediatric procedures ranges from no intervention to support from child life specialists.

As an adjunct to the existing methods of promoting comfort during painful procedures, non-invasive virtual reality (VR) therapy is showing promise as a means of distraction and coping with various medical procedures. The user is transported into a relaxing/distracting VR environment that diverts user's attention away from pain and anxiety. VR has demonstrated efficacy in the reduction of pain and anxiety experienced by individuals undergoing anxiety and pain inducing procedures.While there is early data from small or narrow populations that show some improvement in pain and anxiety with VR use during pediatric procedures, some studies show no improvement. No studies to date have used objective outcome measures of coping, which may be more clinically meaningful.

The investigators propose to fill this gap in the literature with a randomized, controlled, un-blinded study of coping and distress between virtual reality engagement and child life support in pediatric patients undergoing painful medical procedures.

Conditions

Virtual Reality; Pediatrics

Study Design

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

Study Groups

Virtual Reality Group (Study Group)

In this arm, patients will receive support from child life specialists plus may use virtual reality simulation goggles during a qualifying medical procedure.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: OTHER

A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.

Active Control Group

In this arm, patients will receive standard of care with child life specialists plus distraction of the child's choosing, during a qualifying medical procedure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

External Control (Reference Group)

No virtual reality and no child life specialists; no standardized or formal form of support.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality

A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.

Intervention Type: OTHER

Other Intervention Names

Oculus Go

Eligibility Criteria

Inclusion Criteria

1. Pediatric patients requiring painful or anxiety inducing procedures:

• Burn debridement
• Burn dressing change
• Lactation repair
• Intravenous (IV) line placement or phlebotomy (blood draw)
• Abscess incision and drainage
• Fracture reduction and/or cast placement
• Implanted central venous port placement accessing
• Skin biopsies

2. Subjects ages 7 to 26 years of age (age 26 is the upper limit treated at JHCC) Ages were chosen based on that previously published in the literature on pediatric patients with VR.

Exclusion Criteria

• Patients with a known history of a seizure disorder.
• Patients with an active infection, burn, or trauma that interferes with the mask placement, and may include involvement of the periorbital skin, eyes, nasal bridge, external ear, and/or scalp or hair.
• Patients with Blindness.
• Developmental delay significant enough to interfere with the subject's ability to participate in the session, including autism spectrum disorders.
• Patients with active psychosis or exhibit signs of active intoxication.
• Known history of severe motion sickness
• Medical urgency (at the medical providers' discretion)
• Non-verbal children
• Children or parents/legal guardians who are non-English speakers

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Thomas Wilson Sanitarium for Children of Baltimore City

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Therese Canares, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Children's Center

Baltimore, Maryland, United States

Countries

United States

References

Canares T, Parrish C, Santos C, Badawi A, Stewart A, Kleinman K, Psoter K, McGuire J. Pediatric Coping During Venipuncture With Virtual Reality: Pilot Randomized Controlled Trial. JMIR Pediatr Parent. 2021 Jul 28;4(3):e26040. doi: 10.2196/26040.

Reference Type: DERIVED

PMID: 34319249 (View on PubMed)

Canares TL, Parrish C, Santos C, Badawi A, Stewart A, Kleinman K, Psoter KJ, McGuire JF. Resource Use During Pediatric Venipuncture With Virtual Reality: Secondary Analysis of a Randomized Controlled Pilot Trial. Hosp Pediatr. 2021 Jul;11(7):775-778. doi: 10.1542/hpeds.2020-003822. Epub 2021 Jun 14.

Reference Type: DERIVED

PMID: 34127486 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00161331

Identifier Type: -

Identifier Source: org_study_id