NCT03980067

Impact of Pre-Sedation Virtual Reality Game on Post-Discharge Negative Behaviors in the Pediatric Emergency Department

Pediatric Procedural Sedation and the Relationship With Post-Discharge Negative Behavioral Changes in the Emergency Department

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate if a virtual reality (VR) distraction game played prior to procedural sedation for long bone fracture reduction will improve post-discharge negative behavior changes following discharge from the pediatric Emergency Department (ED).

Detailed description

This randomized control trial will investigate the use of a virtual reality (VR) distraction game prior to IV ketamine procedural sedation for long bone fracture reduction. Prior studies have demonstrated that children undergoing anesthesia or procedural sedation can have lingering negative behavioral changes lasting several weeks after discharge home. Children who are anxious have higher rates of developing negative behavior changes. Opiate pain control and pre-operative instructional workshops have demonstrated efficacy in decreasing negative behavior outcomes. There is some evidence that distraction techniques, such as VR, can alleviate pre-procedural anxiety and pain during procedures. To our knowledge, evaluating the use of a non-pharmacologic, virtual reality intervention and its effects on reducing post-discharge negative behavior changes following discharge from the Emergency Department has not been evaluated.

Conditions

• Behavior, Child
• Anxiety

Interventions

Type	Name	Description
OTHER	Virtual Reality Game	The virtual reality headset, device, and software, created by Stanford's Childhood Anxiety Reduction through Innovation and Technology (CHARIOT)program/Weightless Studio, LLC will be utilized in this study. Children in the VR intervention group will be allowed to select a distraction-based game to play with active VR content featuring interactive avatars and interactive experiences tailored to the pediatric population that allow players to do things such as control penguins sliding down a mountain while collecting pebbles for points, control puppies running in space to collect treats to the rhythm of music, and control an asteroid miner exploring an asteroid belt and collecting points based on color of asteroids collected. The game will last a minimum of 5 minutes in duration, provided participant tolerance. The participant may play longer if desired prior to receiving procedural sedation and the total length of activity played will be documented.

Timeline

• Start date: 2019-05-17
• Primary completion: 2022-05-12
• Completion: 2022-05-12
• First posted: 2019-06-10
• Last updated: 2024-07-29

Locations

1 site across 1 country: United States