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Completed

NCT Number: NCT03980067

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

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).

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Key information

Conditions

Behavior, Child Anxiety Anxiety Disorders Behavior Child Behavior Disease Attributes Emergencies Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

virtual reality game

Other

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.

Primary outcomes

  1. Post-Hospitalization Behavior Questionnaire (PHBQ)

    Time frame: 24 months

    Post-Hospitalization Behavior Questionnaire, a parent-report tool, with 27 items in six categories, comprising general, separation, and sleep anxieties, eating disturbance, aggression towards authority, apathy/withdrawal accesses negative behavioral changes in children post-surgery, hospitalization (Kain et al., 1996, Kain et al., 1999) or after minor ED procedures (Brodzinski et al., 2013). It takes 10 minutes and is given prior to the sedation and at 1-week via text/email, phone, or mail follow up post-discharge.

    Parents compare their child's behavior pre-hospitalization to post using the following: much less than before (1), less than before (2), same as before (3), more than before (4), and much more than before (5). Scores above 3 indicate greater maladaptive behavioral changes, below 3 indicate improvements and 3 indicates no change in behavior.

Secondary outcomes

  1. Modified Yale Preoperative Anxiety Scale (m-YPAS)

    Time frame: 24 months

    The m-YPAS assesses study participant's anxiety at the time of induction of anesthesia. It is completed in <1 minute, reliable, and its validity compares favorably to the State Trait Anxiety Inventory for Children (Kain, Z. 1997). The Emergency Department provider completes the m-YPAS twice during the study: on patient arrival/enrollment and immediately preceding sedation after VR intervention or standard of care.

    m-YPAS categories are activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parent). Each item has Likert-type responses reflecting children behaviors and is rated from 1 to 4 or 1 to 6 (depending on the item), and higher numbers indicate the highest severity within that item.

    Scores range from 23-100 and a score >30 is defined as anxious.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 10, 2019
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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