NCT03686176

Virtual Reality During Procedures in Pediatric Patients

Terminated NA Results posted Last updated 6 August 2020

What this trial tests

NA trial testing Virtual Reality in Virtual Reality in 64 participants. Terminated before completion.

Timeline

5 July 2019

Primary endpoint
30 March 2020

30 March 2020

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	64
Start date	5 July 2019
Primary completion	30 March 2020
Estimated completion	30 March 2020
Sites	1 location across United States

Drugs / interventions tested

• Virtual Reality

Conditions studied

• Virtual Reality — all drugs for Virtual Reality →
• Pediatrics — all drugs for Pediatrics →

Sponsor

Johns Hopkins University

Who can join

Adults 7 to 26, any sex, with Virtual Reality or Pediatrics. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Patient-Reported Pain During the Procedure Primary · Baseline and Immediately post-procedure, up to 15 minutes

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.

Group	Value	95% CI
Virtual Reality Group (Study Group)	-0.65	± 4.36
Standard Care (Control Group)	-1.04	± 3.86
Reference Group	0.95	± 2.35

Change in Patient-Reported Anxiety During Procedure Primary · Baseline and Immediately post-procedure, up to 15 minutes

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.

Group	Value	95% CI
Virtual Reality Group (Study Group)	-0.24	± 3.38
Standard Care (Control Group)	-0.24	± 2.76
Reference Group	1.45	± 3.32

Change in Adult Perceived Pain During the Procedure Primary · Baseline and Immediately post-procedure, up to 15 minutes

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.

Group	Value	95% CI
Virtual Reality Group (Study Group)	-1.65	± 3.35
Standard Care (Control Group)	-1.70	± 3.74
Reference Group	0	± 2.52

Change in Adult Perceived Anxiety During the Procedure Primary · Baseline and Immediately post-procedure, up to 15 minutes

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.

Group	Value	95% CI
Virtual Reality Group (Study Group)	-1.12	± 4.06
Standard Care (Control Group)	-1.10	± 2.57
Reference Group	1.29	± 2.47

Change in Adult's Own Anxiety During the Procedure Primary · Baseline and Immediately post-procedure, up to 15 minutes

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.

Group	Value	95% CI
Virtual Reality Group (Study Group)	0.76	± 3.85
Standard Care (Control Group)	-0.95	± 2.21
Reference Group	0.35	± 1.32

Child and Adult Medical Procedure Interaction Scale (CAMPIS) Score Primary · Immediately post-procedure, up to 15minutes

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

Child Coping Proportion

Group	Value	95% CI
Virtual Reality Group (Study Group)	0.87	± .18
Standard Care (Control Group)	.86	± .18
Reference Group	.70	± .39

Child Distress Proportion

Group	Value	95% CI
Virtual Reality Group (Study Group)	0.13	± .18
Standard Care (Control Group)	.14	± .18
Reference Group	.20	± .31

Caregiver Coping Proportion

Group	Value	95% CI
Virtual Reality Group (Study Group)	0.58	± 0.39
Standard Care (Control Group)	.48	± .46
Reference Group	.57	± .43

Caregiver Distress Proportion

Group	Value	95% CI
Virtual Reality Group (Study Group)	.25	± 0.30
Standard Care (Control Group)	.12	± .24
Reference Group	.20	± .31

Duration of Procedure Secondary · Immediately post-procedure, up to 20 minutes

Duration of procedure in minutes will be assessed for each procedure.

Group	Value	95% CI
Virtual Reality Group (Study Group)	13.35	± 10.29
Standard Care (Control Group)	9.24	± 6.58
Reference Group	5.1	± 4.97

Ease of Procedure as Assessed by a Likert Scale Secondary · Immediately post-procedure, up to 15 minutes

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.

Group	Value	95% CI
Virtual Reality Group (Study Group)	1.4	± 2.6
Standard Care (Control Group)	0.6	± 1.3
Reference Group	0.7	± 1.3

Personnel Use for Immobilization Secondary · Immediately post-procedure, up to 15 minutes

This will be assessed using number of patients requiring immobilization during procedures.

Group	Value	95% CI
Virtual Reality Group (Study Group)	4
Standard Care (Control Group)	2
Reference Group	0

Number of IV or Phlebotomy Attempts Secondary · Immediately post-procedure, up to 15 minutes

Number of IV or phlebotomy attempts until success will be counted (1 or 2+) in patients undergoing venipuncture procedures.

1 Attempt

Group	Value	95% CI
Virtual Reality Group (Study Group)	13
Standard Care (Control Group)	16
Reference Group	17

2+ Attempts

Group	Value	95% CI
Virtual Reality Group (Study Group)	2
Standard Care (Control Group)	4
Reference Group	3

Pre-Procedure Nausea Symptoms Secondary · Immediately pre-procedure (15minutes)

The number of patients reporting nausea symptoms prior to the procedure

Group	Value	95% CI
Virtual Reality Group (Study Group)	2
Standard Care (Control Group)	8
Reference Group	4

Pre-Procedure Cybersickness Symptoms Secondary · Immediately pre-procedure (15minutes)

Number of patients in the VR group reporting positive cybersickness symptoms prior to the procedure

Group	Value	95% CI
Virtual Reality Group (Study Group)	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Immediately post-procedure, up to 15minutes.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Virtual Reality Group (Study Group)

Serious: 0/19 (0%)

Deaths: 0/19

Standard Care (Control Group)

Serious: 0/25 (0%)

Deaths: 0/25

Reference Group

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (2 terms — click to expand)

Reaction	System	Virtual Reality Group (Stu…	Standard Care (Control Gro…	Reference Group
Post-Procedure Nausea	General disorders	—	—	—
Cybersickness Post-Procedure	General disorders	—	—	—

Data from ClinicalTrials.gov NCT03686176 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pediatric Coping During Venipuncture With Virtual Reality: Pilot Randomized Controlled Trial.
   Canares T, Parrish C, Santos C, Badawi A, et al · · 2021 · cited 22× · PMID 34319249 · DOI 10.2196/26040