Virtual Reality During Procedures in Pediatric Patients

This stratified, randomized, controlled trial compared coping and distress between child life supported virtual reality engagement and child life support during painful procedures in the pediatric emergency department.

Study Overview

• Status: Terminated
• Conditions: Virtual Reality; Pediatrics
• Intervention / Treatment: Other: Virtual Reality

Detailed Description

Pediatric emergency rooms and hospitals are anxiety provoking and often painful places for pediatric patients and families. Children of all ages present to the Johns Hopkins emergency room and are admitted to the hospital for a wide range of medical conditions, many of which require medical interventions. Many of these interventions are the source of anxiety and pain, including burn debridement or dressing changes, laceration repair, or intravenous (IV) line placement. The standard of care to reduce pain and improve coping during pediatric procedures ranges from no intervention to support from child life specialists.

As an adjunct to the existing methods of promoting comfort during painful procedures, non-invasive virtual reality (VR) therapy is showing promise as a means of distraction and coping with various medical procedures. The user is transported into a relaxing/distracting VR environment that diverts user's attention away from pain and anxiety. VR has demonstrated efficacy in the reduction of pain and anxiety experienced by individuals undergoing anxiety and pain inducing procedures.While there is early data from small or narrow populations that show some improvement in pain and anxiety with VR use during pediatric procedures, some studies show no improvement. No studies to date have used objective outcome measures of coping, which may be more clinically meaningful.

The investigators propose to fill this gap in the literature with a randomized, controlled, un-blinded study of coping and distress between virtual reality engagement and child life support in pediatric patients undergoing painful medical procedures.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21212
      • Johns Hopkins Children's Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 26 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Pediatric patients requiring painful or anxiety inducing procedures:

   • Burn debridement
   • Burn dressing change
   • Lactation repair
   • Intravenous (IV) line placement or phlebotomy (blood draw)
   • Abscess incision and drainage
   • Fracture reduction and/or cast placement
   • Implanted central venous port placement accessing
   • Skin biopsies
2. Subjects ages 7 to 26 years of age (age 26 is the upper limit treated at JHCC) Ages were chosen based on that previously published in the literature on pediatric patients with VR.

Exclusion Criteria:

• Patients with a known history of a seizure disorder.
• Patients with an active infection, burn, or trauma that interferes with the mask placement, and may include involvement of the periorbital skin, eyes, nasal bridge, external ear, and/or scalp or hair.
• Patients with Blindness.
• Developmental delay significant enough to interfere with the subject's ability to participate in the session, including autism spectrum disorders.
• Patients with active psychosis or exhibit signs of active intoxication.
• Known history of severe motion sickness
• Medical urgency (at the medical providers' discretion)
• Non-verbal children
• Children or parents/legal guardians who are non-English speakers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Group (Study Group); In this arm, patients will receive support from child life specialists plus may use virtual reality simulation goggles during a qualifying medical procedure.	Other: Virtual Reality; A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.; Other Names: Oculus Go
No Intervention: Active Control Group; In this arm, patients will receive standard of care with child life specialists plus distraction of the child's choosing, during a qualifying medical procedure.
No Intervention: External Control (Reference Group); No virtual reality and no child life specialists; no standardized or formal form of support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient-Reported Pain During the Procedure	Pain described on visual analog scale (0-10), or Wong-Faces Scale (0-10) with 0 being no pain and 10 being worst pain. Change in pain scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced pain during the procedure.	Baseline and Immediately post-procedure, up to 15 minutes
Change in Patient-Reported Anxiety During Procedure	Patient anxiety after procedures was described on a visual analog scale (0-10). This is a scale of range 0-10 with 0 being no anxiety and 10 being maximum anxiety. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure.	Baseline and Immediately post-procedure, up to 15 minutes
Change in Adult Perceived Pain During the Procedure	Perceived pain ratings were obtained for caregivers after the procedure based on a 0-10 Likert rating scale with 0 representing the least pain and 10 representing the most. Change in pain scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced pain during the procedure. This measure was assessed in caregivers.	Baseline and Immediately post-procedure, up to 15 minutes
Change in Adult Perceived Anxiety During the Procedure	The Subjective Units of Distress scale will be used to measure anxiety of subjects after procedures. This is a scale of 0-10 with 0 being no anxiety and 10 being maximum anxiety. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure. This measure was assessed in caregivers.	Baseline and Immediately post-procedure, up to 15 minutes
Change in Adult's Own Anxiety During the Procedure	Anxiety ratings were obtained for caregivers after the procedure based on a 0-10 Likert rating scale with 0 representing the least anxiety and 10 representing the most. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure. This measure was assessed in caregivers.	Baseline and Immediately post-procedure, up to 15 minutes
Child and Adult Medical Procedure Interaction Scale (CAMPIS) Score	Coping was measured using a modified CAMPIS-SF in both patients and caregivers. CAMPIS-SF (Child-Adult Medical Procedure Interaction Scale-Short Form) is a behavior rating scale that documents distressing or coping behaviors exhibited in both children and the accompanying adult (parent/guardian). It has been validated to measure coping in children and adults during medical procedures. The CAMPIS-SF study used a 5-point Likert scale to document frequency of each code In order to account for frequency variance due to differences in procedure duration, we used a proportion-based metric validated for CAMPIS-R, and applied this to CAMPIS-SF codes. Proportions were calculated by summing the total number of an event type (e.g. child distress) and dividing by the total number of coded events (child distress plus child coping). This provided a proportion for each event type so that the proportion of child distress plus child coping events add up to 1.0 (range 0-1.0).	Immediately post-procedure, up to 15minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Procedure	Duration of procedure in minutes will be assessed for each procedure.	Immediately post-procedure, up to 20 minutes
Ease of Procedure as Assessed by a Likert Scale	Ease of procedure will be assessed using a Likert scale completed by proceduralist. The Likert scale ranges from 0-10 with 0 being easy and 10 difficult.	Immediately post-procedure, up to 15 minutes
Personnel Use for Immobilization	This will be assessed using number of patients requiring immobilization during procedures.	Immediately post-procedure, up to 15 minutes
Number of IV or Phlebotomy Attempts	Number of IV or phlebotomy attempts until success will be counted (1 or 2+) in patients undergoing venipuncture procedures.	Immediately post-procedure, up to 15 minutes
Pre-Procedure Nausea Symptoms	The number of patients reporting nausea symptoms prior to the procedure	Immediately pre-procedure (15minutes)
Pre-Procedure Cybersickness Symptoms	Number of patients in the VR group reporting positive cybersickness symptoms prior to the procedure	Immediately pre-procedure (15minutes)

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: The Thomas Wilson Sanitarium for Children of Baltimore City
• Investigators: Principal Investigator: Therese Canares, MD, Johns Hopkins University

Publications and helpful links

General Publications

• Canares T, Parrish C, Santos C, Badawi A, Stewart A, Kleinman K, Psoter K, McGuire J. Pediatric Coping During Venipuncture With Virtual Reality: Pilot Randomized Controlled Trial. JMIR Pediatr Parent. 2021 Jul 28;4(3):e26040. doi: 10.2196/26040.
• Canares TL, Parrish C, Santos C, Badawi A, Stewart A, Kleinman K, Psoter KJ, McGuire JF. Resource Use During Pediatric Venipuncture With Virtual Reality: Secondary Analysis of a Randomized Controlled Pilot Trial. Hosp Pediatr. 2021 Jul;11(7):775-778. doi: 10.1542/hpeds.2020-003822. Epub 2021 Jun 14.

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2019
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: September 25, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): August 6, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IRB00161331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No