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

Medical College of Wisconsin logo

Medical College of Wisconsin

Status

Completed

Conditions

Behavior, Child
Anxiety

Treatments

Other: Virtual Reality Game

Study type

Interventional

Funder types

Other

Identifiers

NCT03980067
1300058-5

Details and patient eligibility

About

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).

Full 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.

Enrollment

201 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children ages 6 years to 17.5 years old receiving procedural sedation with IV ketamine in the Children's Hospital of Wisconsin Emergency Department for long bone fracture reduction

Exclusion criteria

  • Moderate to severe developmental delay
  • Non-English-speaking participants or parent/guardian
  • Taking psychotropic medications
  • History of severe motion sickness
  • Currently experiencing nausea/vomiting
  • History of severe visual impairment
  • History of seizures
  • Expected admission to the hospital post-procedure

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

201 participants in 2 patient groups

Virtual Reality Group
Experimental group
Description:
The children in the experimental group will receive the standard of care (access to in room activity including television (TV) distraction if desired, parent support and distraction at bedside, and quiet time) in addition to our intervention, an interactive virtual reality game, played for a minimum of 5 minutes prior to procedural sedation.
Treatment:
Other: Virtual Reality Game
Standard of Care
No Intervention group
Description:
The children in the control group receiving standard of care will have access to in room activity including TV distraction if desired, parent support and distraction at bedside, and quiet time.

Trial documents
3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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