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

NCT03980067 | Completed

• 1 other identifier: 1300058-5
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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).

Conditions

Behavior, Child; Anxiety

Keywords

Virtual Reality; Procedural Sedation; Modified Yale Preoperative Anxiety Scale; Post-Hospitalization Behavior Questionnaire; Pediatric; Emergency Department; Ketamine

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (1)

• Modified Yale Preoperative Anxiety Scale (m-YPAS)

  24 months

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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.

Interventions

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.

Virtual Reality Group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (15)

• Asl Aminabadi N, Erfanparast L, Sohrabi A, Ghertasi Oskouei S, Naghili A. The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2012 Fall;6(4):117-24. doi: 10.5681/joddd.2012.025. Epub 2012 Nov 12.

  PMID: 23277857 BACKGROUND

• Brodzinski H, Iyer S. Behavior changes after minor emergency procedures. Pediatr Emerg Care. 2013 Oct;29(10):1098-101. doi: 10.1097/PEC.0b013e3182a5ff07.

  PMID: 24076612 BACKGROUND

• CHARIOT Program - Childhood Anxiety Reduction through Innovation and Technology - Stanford Children's Health. (n.d.). Retrieved August 7, 2018, from https://www.stanfordchildrens.org/en/innovation/chariot

  BACKGROUND

• Kain ZN, Caldwell-Andrews AA, Maranets I, Nelson W, Mayes LC. Predicting which child-parent pair will benefit from parental presence during induction of anesthesia: a decision-making approach. Anesth Analg. 2006 Jan;102(1):81-4. doi: 10.1213/01.ANE.0000181100.27931.A1.

  PMID: 16368808 BACKGROUND

• Kim JE, Jo BY, Oh HM, Choi HS, Lee Y. High anxiety, young age and long waits increase the need for preoperative sedatives in children. J Int Med Res. 2012;40(4):1381-9. doi: 10.1177/147323001204000416.

  PMID: 22971489 BACKGROUND

• Kain ZN, Wang SM, Mayes LC, Caramico LA, Hofstadter MB. Distress during the induction of anesthesia and postoperative behavioral outcomes. Anesth Analg. 1999 May;88(5):1042-7. doi: 10.1097/00000539-199905000-00013.

  PMID: 10320165 BACKGROUND

• Pearce JI, Brousseau DC, Yan K, Hainsworth KR, Hoffmann RG, Drendel AL. Behavioral Changes in Children After Emergency Department Procedural Sedation. Acad Emerg Med. 2018 Mar;25(3):267-274. doi: 10.1111/acem.13332. Epub 2017 Nov 13.

  PMID: 28992364 BACKGROUND

• Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.

  PMID: 9322455 BACKGROUND

• Sinha M, Christopher NC, Fenn R, Reeves L. Evaluation of nonpharmacologic methods of pain and anxiety management for laceration repair in the pediatric emergency department. Pediatrics. 2006 Apr;117(4):1162-8. doi: 10.1542/peds.2005-1100.

  PMID: 16585311 BACKGROUND

• Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.

  PMID: 8953995 BACKGROUND

• Wismeijer AA, Vingerhoets AJ. The use of virtual reality and audiovisual eyeglass systems as adjunct analgesic techniques: a review of the literature. Ann Behav Med. 2005 Dec;30(3):268-78. doi: 10.1207/s15324796abm3003_11.

  PMID: 16336078 BACKGROUND

• Jenkins BN, Kain ZN, Kaplan SH, Stevenson RS, Mayes LC, Guadarrama J, Fortier MA. Revisiting a measure of child postoperative recovery: development of the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery. Paediatr Anaesth. 2015 Jul;25(7):738-45. doi: 10.1111/pan.12678. Epub 2015 May 9.

  PMID: 25958978 BACKGROUND

• Kuhlmann AYR, Lahdo N, Staals LM, van Dijk M. What are the validity and reliability of the modified Yale Preoperative Anxiety Scale-Short Form in children less than 2 years old? Paediatr Anaesth. 2019 Feb;29(2):137-143. doi: 10.1111/pan.13536. Epub 2018 Dec 23.

  PMID: 30365208 BACKGROUND

• Thung A, Tumin D, Uffman JC, Tobias JD, Buskirk T, Garrett W, Karczewski A, Saadat H. The Utility of the Modified Yale Preoperative Anxiety Scale for Predicting Success in Pediatric Patients Undergoing MRI Without the Use of Anesthesia. J Am Coll Radiol. 2018 Sep;15(9):1232-1237. doi: 10.1016/j.jacr.2017.12.022. Epub 2018 Mar 2.

  PMID: 29483054 BACKGROUND

• Jenkins BN, Fortier MA, Kaplan SH, Mayes LC, Kain ZN. Development of a short version of the modified Yale Preoperative Anxiety Scale. Anesth Analg. 2014 Sep;119(3):643-650. doi: 10.1213/ANE.0000000000000350.

  PMID: 25010821 BACKGROUND

MeSH Terms

Conditions

Child Behavior; Anxiety Disorders; Emergencies

Condition Hierarchy (Ancestors)

Behavior; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amy Drendel, DO, MS

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, DO, MS

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 10, 2019
• Study Start: May 17, 2019
• Primary Completion: May 12, 2022
• Study Completion: May 12, 2022
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)