Trial Outcomes & Findings for Virtual Reality During Procedures in Pediatric Patients (NCT NCT03686176)

NCT ID: NCT03686176

Last Updated: 2020-08-06

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 64 participants
• Primary outcome timeframe: Baseline and Immediately post-procedure, up to 15 minutes
• Results posted on: 2020-08-06

Participant Flow

This study was conducted in the pediatric emergency department (PED) at an urban, tertiary care children's hospital.

Participant milestones

Measure	Virtual Reality Group (Study Group) In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure. Virtual Reality (VR): A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.	Standard Care (Control Group) In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure.	Reference Group No virtual reality and no child life specialists; no standardized or formal form of support.
Overall Study STARTED	19	25	20
Overall Study COMPLETED	17	25	20
Overall Study NOT COMPLETED	2	0	0

Reasons for withdrawal

Measure	Virtual Reality Group (Study Group) In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure. Virtual Reality (VR): A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.	Standard Care (Control Group) In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure.	Reference Group No virtual reality and no child life specialists; no standardized or formal form of support.
Overall Study Procedure cancelled	1	0	0
Overall Study VR Malfunction	1	0	0

Baseline Characteristics

Virtual Reality During Procedures in Pediatric Patients

Baseline characteristics by cohort

Measure	Virtual Reality Group (Study Group) n=17 Participants In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure. Virtual Reality: A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.	Standard Care (Control Group) n=25 Participants In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure.	Reference Group n=20 Participants No virtual reality and no child life specialists; no standardized or formal form of support.	Total n=62 Participants Total of all reporting groups
Age, Customized Child (7-9 years)	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Age, Customized Early Adolescent (10-13 years)	7 Participants n=5 Participants	9 Participants n=7 Participants	3 Participants n=5 Participants	19 Participants n=4 Participants
Age, Customized Middle Adolescent (14-17 years)	6 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	22 Participants n=4 Participants
Age, Customized Late Adolescent/Adult (18+ years)	1 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	36 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	12 Participants n=7 Participants	8 Participants n=5 Participants	26 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	23 Participants n=7 Participants	20 Participants n=5 Participants	58 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	16 Participants n=7 Participants	11 Participants n=5 Participants	33 Participants n=4 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	24 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment United States	17 Participants n=5 Participants	25 Participants n=7 Participants	20 Participants n=5 Participants	62 Participants n=4 Participants
Type of Procedure Venipuncture (IV/blood draw)	17 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	57 Participants n=4 Participants
Type of Procedure Burn debridement	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Type of Procedure Laceration repair	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Type of Procedure Abscess drainage	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Type of Procedure Cast Placement	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Child Baseline Pain Level	4.50 score on a scale STANDARD_DEVIATION 2.74 • n=5 Participants	4.56 score on a scale STANDARD_DEVIATION 3.73 • n=7 Participants	4.75 score on a scale STANDARD_DEVIATION 3.46 • n=5 Participants	4.56 score on a scale STANDARD_DEVIATION 3.35 • n=4 Participants
Child Baseline Anxiety Level	3.94 score on a scale STANDARD_DEVIATION 2.56 • n=5 Participants	3.32 score on a scale STANDARD_DEVIATION 3.48 • n=7 Participants	2.00 score on a scale STANDARD_DEVIATION 2.79 • n=5 Participants	3.03 score on a scale STANDARD_DEVIATION 3.08 • n=4 Participants
Adult Baseline Perceived Pain Level	4.69 score on a scale STANDARD_DEVIATION 2.68 • n=5 Participants	4.95 score on a scale STANDARD_DEVIATION 3.39 • n=7 Participants	5.44 score on a scale STANDARD_DEVIATION 2.88 • n=5 Participants	5.03 score on a scale STANDARD_DEVIATION 2.99 • n=4 Participants
Adult Baseline Perceived Anxiety Level	5.25 score on a scale STANDARD_DEVIATION 2.37 • n=5 Participants	4.65 score on a scale STANDARD_DEVIATION 3.23 • n=7 Participants	2.47 score on a scale STANDARD_DEVIATION 3.71 • n=5 Participants	4.21 score on a scale STANDARD_DEVIATION 3.35 • n=4 Participants
Adult Baseline Own Anxiety Level	4.13 score on a scale STANDARD_DEVIATION 3.59 • n=5 Participants	2.95 score on a scale STANDARD_DEVIATION 3.12 • n=7 Participants	0.47 score on a scale STANDARD_DEVIATION 1.12 • n=5 Participants	2.51 score on a scale STANDARD_DEVIATION 3.15 • n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Virtual Reality Group (Study Group) n=17 Participants In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure. Virtual Reality: A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.	Standard Care (Control Group) n=25 Participants In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure.	Reference Group n=20 Participants No virtual reality and no child life specialists; no standardized or formal form of support.
Change in Patient-Reported Pain During the Procedure	-0.65 Visual Analog scale range 0-10 Standard Deviation 4.36	-1.04 Visual Analog scale range 0-10 Standard Deviation 3.86	0.95 Visual Analog scale range 0-10 Standard Deviation 2.35

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Virtual Reality Group (Study Group) n=17 Participants In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure. Virtual Reality: A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.	Standard Care (Control Group) n=25 Participants In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure.	Reference Group n=20 Participants No virtual reality and no child life specialists; no standardized or formal form of support.
Change in Patient-Reported Anxiety During Procedure	-0.24 Visual Analog scale range 0-10 Standard Deviation 3.38	-0.24 Visual Analog scale range 0-10 Standard Deviation 2.76	1.45 Visual Analog scale range 0-10 Standard Deviation 3.32

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Virtual Reality Group (Study Group) n=17 Participants In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure. Virtual Reality: A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.	Standard Care (Control Group) n=25 Participants In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure.	Reference Group n=20 Participants No virtual reality and no child life specialists; no standardized or formal form of support.
Change in Adult Perceived Pain During the Procedure	-1.65 Likert rating scale range 0-10 Standard Deviation 3.35	-1.70 Likert rating scale range 0-10 Standard Deviation 3.74	0 Likert rating scale range 0-10 Standard Deviation 2.52

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Virtual Reality Group (Study Group) n=17 Participants In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure. Virtual Reality: A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.	Standard Care (Control Group) n=25 Participants In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure.	Reference Group n=20 Participants No virtual reality and no child life specialists; no standardized or formal form of support.
Change in Adult Perceived Anxiety During the Procedure	-1.12 Likert scale range 0-10 Standard Deviation 4.06	-1.10 Likert scale range 0-10 Standard Deviation 2.57	1.29 Likert scale range 0-10 Standard Deviation 2.47

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Virtual Reality Group (Study Group) n=17 Participants In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure. Virtual Reality: A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.	Standard Care (Control Group) n=25 Participants In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure.	Reference Group n=20 Participants No virtual reality and no child life specialists; no standardized or formal form of support.
Change in Adult's Own Anxiety During the Procedure	0.76 Likert scale range 0-10 Standard Deviation 3.85	-0.95 Likert scale range 0-10 Standard Deviation 2.21	0.35 Likert scale range 0-10 Standard Deviation 1.32

PRIMARY outcome

Timeframe: Immediately post-procedure, up to 15minutes

Population: 13, 20 and 17 caregivers for the respective arms were analyzed for this outcome measure.

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).

Outcome measures

Measure	Virtual Reality Group (Study Group) n=17 Participants In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure. Virtual Reality: A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.	Standard Care (Control Group) n=25 Participants In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure.	Reference Group n=20 Participants No virtual reality and no child life specialists; no standardized or formal form of support.
Child and Adult Medical Procedure Interaction Scale (CAMPIS) Score Child Coping Proportion	0.87 Proportion of total CAMPIS score Standard Deviation .18	.86 Proportion of total CAMPIS score Standard Deviation .18	.70 Proportion of total CAMPIS score Standard Deviation .39
Child and Adult Medical Procedure Interaction Scale (CAMPIS) Score Child Distress Proportion	0.13 Proportion of total CAMPIS score Standard Deviation .18	.14 Proportion of total CAMPIS score Standard Deviation .18	.20 Proportion of total CAMPIS score Standard Deviation .31
Child and Adult Medical Procedure Interaction Scale (CAMPIS) Score Caregiver Coping Proportion	0.58 Proportion of total CAMPIS score Standard Deviation 0.39	.48 Proportion of total CAMPIS score Standard Deviation .46	.57 Proportion of total CAMPIS score Standard Deviation .43
Child and Adult Medical Procedure Interaction Scale (CAMPIS) Score Caregiver Distress Proportion	.25 Proportion of total CAMPIS score Standard Deviation 0.30	.12 Proportion of total CAMPIS score Standard Deviation .24	.20 Proportion of total CAMPIS score Standard Deviation .31

SECONDARY outcome

Timeframe: Immediately post-procedure, up to 20 minutes

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

Outcome measures

Measure	Virtual Reality Group (Study Group) n=17 Participants In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure. Virtual Reality: A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.	Standard Care (Control Group) n=25 Participants In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure.	Reference Group n=20 Participants No virtual reality and no child life specialists; no standardized or formal form of support.
Duration of Procedure	13.35 minutes Standard Deviation 10.29	9.24 minutes Standard Deviation 6.58	5.1 minutes Standard Deviation 4.97

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Virtual Reality Group (Study Group) n=17 Participants In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure. Virtual Reality: A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.	Standard Care (Control Group) n=25 Participants In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure.	Reference Group n=20 Participants No virtual reality and no child life specialists; no standardized or formal form of support.
Ease of Procedure as Assessed by a Likert Scale	1.4 Likert scale range 0-10 Standard Deviation 2.6	0.6 Likert scale range 0-10 Standard Deviation 1.3	0.7 Likert scale range 0-10 Standard Deviation 1.3

SECONDARY outcome

Timeframe: Immediately post-procedure, up to 15 minutes

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

Outcome measures

Measure	Virtual Reality Group (Study Group) n=17 Participants In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure. Virtual Reality: A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.	Standard Care (Control Group) n=25 Participants In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure.	Reference Group n=20 Participants No virtual reality and no child life specialists; no standardized or formal form of support.
Personnel Use for Immobilization	4 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Immediately post-procedure, up to 15 minutes

Population: This is a sub-analysis of the population undergoing venipuncture procedures only. 5 in the CL group and 2 in the VR group were excluded due to non-venipuncture procedures. 2 patients in the VR group were excluded due to a medical emergency and procedure cancellation.

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

Outcome measures

Measure	Virtual Reality Group (Study Group) n=15 Participants In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure. Virtual Reality: A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.	Standard Care (Control Group) n=20 Participants In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure.	Reference Group n=20 Participants No virtual reality and no child life specialists; no standardized or formal form of support.
Number of IV or Phlebotomy Attempts 2+ Attempts	2 Participants	4 Participants	3 Participants
Number of IV or Phlebotomy Attempts 1 Attempt	13 Participants	16 Participants	17 Participants

SECONDARY outcome

Timeframe: Immediately pre-procedure (15minutes)

The number of patients reporting nausea symptoms prior to the procedure

Outcome measures

Measure	Virtual Reality Group (Study Group) n=17 Participants In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure. Virtual Reality: A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.	Standard Care (Control Group) n=25 Participants In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure.	Reference Group n=20 Participants No virtual reality and no child life specialists; no standardized or formal form of support.
Pre-Procedure Nausea Symptoms	2 Participants	8 Participants	4 Participants

SECONDARY outcome

Timeframe: Immediately pre-procedure (15minutes)

Population: Included patients randomized to VR during the procedure

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

Outcome measures

Measure	Virtual Reality Group (Study Group) n=17 Participants In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure. Virtual Reality: A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.	Standard Care (Control Group) In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure.	Reference Group No virtual reality and no child life specialists; no standardized or formal form of support.
Pre-Procedure Cybersickness Symptoms	2 Participants	—	—

Adverse Events

Virtual Reality Group (Study Group)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Standard Care (Control Group)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Reference Group

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Virtual Reality Group (Study Group) n=19 participants at risk In this arm, patients will receive standard of care plus may use virtual reality simulation goggles during a qualifying medical procedure. Virtual Reality: A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.	Standard Care (Control Group) n=25 participants at risk In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure.	Reference Group n=20 participants at risk No virtual reality and no child life specialists; no standardized or formal form of support.
General disorders Post-Procedure Nausea	5.3% 1/19 • Immediately post-procedure, up to 15minutes. Symptoms of Cybersickness from the Simulator Sickness Questionnaire. The questionnaire has 16 symptoms with each symptom being scored as present (positive) or absent (negative). Patients with any cybersickness symptoms were designated as 'positive' for cybersickness.	16.0% 4/25 • Immediately post-procedure, up to 15minutes. Symptoms of Cybersickness from the Simulator Sickness Questionnaire. The questionnaire has 16 symptoms with each symptom being scored as present (positive) or absent (negative). Patients with any cybersickness symptoms were designated as 'positive' for cybersickness.	20.0% 4/20 • Immediately post-procedure, up to 15minutes. Symptoms of Cybersickness from the Simulator Sickness Questionnaire. The questionnaire has 16 symptoms with each symptom being scored as present (positive) or absent (negative). Patients with any cybersickness symptoms were designated as 'positive' for cybersickness.
General disorders Cybersickness Post-Procedure	10.5% 2/19 • Immediately post-procedure, up to 15minutes. Symptoms of Cybersickness from the Simulator Sickness Questionnaire. The questionnaire has 16 symptoms with each symptom being scored as present (positive) or absent (negative). Patients with any cybersickness symptoms were designated as 'positive' for cybersickness.	0.00% 0/25 • Immediately post-procedure, up to 15minutes. Symptoms of Cybersickness from the Simulator Sickness Questionnaire. The questionnaire has 16 symptoms with each symptom being scored as present (positive) or absent (negative). Patients with any cybersickness symptoms were designated as 'positive' for cybersickness.	0.00% 0/20 • Immediately post-procedure, up to 15minutes. Symptoms of Cybersickness from the Simulator Sickness Questionnaire. The questionnaire has 16 symptoms with each symptom being scored as present (positive) or absent (negative). Patients with any cybersickness symptoms were designated as 'positive' for cybersickness.

Additional Information

Therese Canares

Johns Hopkins University

Phone: 4109964711

Email: tcanare1@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place