NCT03686176

Virtual Reality During Procedures in Pediatric Patients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 7 Years – 26 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	Virtual Reality	A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.

Timeline

• Start date: 2019-07-05
• Primary completion: 2020-03-30
• Completion: 2020-03-30
• First posted: 2018-09-26
• Last updated: 2020-08-06
• Results posted: 2020-07-28

Locations

1 site across 1 country: United States