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

Sponsor

Medical College of Wisconsin (Other)

Overall Status

Recruiting

CT.gov ID

NCT03980067

Collaborator

(none)

243

Enrollment

Location

Arms

38.5

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Behavior, Child Anxiety	Other: Virtual Reality Game	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

243 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 17, 2019

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Virtual Reality Group 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.	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.
No Intervention: Standard of Care 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.

Arm

Intervention/Treatment

Experimental: Virtual Reality Group

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.

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.

No Intervention: Standard of Care

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.

Outcome Measures

Primary Outcome Measures

Post-Hospitalization Behavior Questionnaire (PHBQ) [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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