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

Primary Purpose

Behavior, Child, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Game
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Behavior, Child focused on measuring Virtual Reality, Procedural Sedation, Modified Yale Preoperative Anxiety Scale, Post-Hospitalization Behavior Questionnaire, Pediatric, Emergency Department, Ketamine

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Children's Hospital of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality Group

Standard of Care

Arm 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.

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.

Outcomes

Primary Outcome Measures

Post-Hospitalization Behavior Questionnaire (PHBQ)
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)
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.

Full Information

First Posted
June 6, 2019
Last Updated
January 29, 2023
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT03980067
Brief Title
Impact of Pre-Sedation Virtual Reality Game on Post-Discharge Negative Behaviors in the Pediatric Emergency Department
Official Title
Pediatric Procedural Sedation and the Relationship With Post-Discharge Negative Behavioral Changes in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 17, 2019 (Actual)
Primary Completion Date
May 12, 2022 (Actual)
Study Completion Date
May 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior, Child, Anxiety
Keywords
Virtual Reality, Procedural Sedation, Modified Yale Preoperative Anxiety Scale, Post-Hospitalization Behavior Questionnaire, Pediatric, Emergency Department, Ketamine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Group
Arm Type
Experimental
Arm 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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Virtual Reality Game
Intervention Description
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 Outcome Measure Information:
Title
Post-Hospitalization Behavior Questionnaire (PHBQ)
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Modified Yale Preoperative Anxiety Scale (m-YPAS)
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Drendel, DO, MS
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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23277857
Citation
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Impact of Pre-Sedation Virtual Reality Game on Post-Discharge Negative Behaviors in the Pediatric Emergency Department

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