Virtual Reality During Procedures in Pediatric Patients

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03686176

Enrollment

Registered

2018-09-26

Start date

2019-07-05

Completion date

2020-03-30

Last updated

2020-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatrics, Virtual Reality

Brief summary

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.

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.

Interventions

OTHERVirtual Reality

A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

randomized, unblinded, controlled

Eligibility

Sex/Gender

ALL

Age

7 Years to 26 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Child and Adult Medical Procedure Interaction Scale (CAMPIS) Score	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 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).
Change in Patient-Reported Pain During the Procedure	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.
Change in Patient-Reported Anxiety During Procedure	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.
Change in Adult Perceived Pain During the Procedure	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.
Change in Adult Perceived Anxiety During the Procedure	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.
Change in Adult's Own Anxiety During the Procedure	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.

Secondary

Measure	Time frame	Description
Duration of Procedure	Immediately post-procedure, up to 20 minutes	Duration of procedure in minutes will be assessed for each procedure.
Ease of Procedure as Assessed by a Likert Scale	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.
Personnel Use for Immobilization	Immediately post-procedure, up to 15 minutes	This will be assessed using number of patients requiring immobilization during procedures.
Number of IV or Phlebotomy Attempts	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.
Pre-Procedure Nausea Symptoms	Immediately pre-procedure (15minutes)	The number of patients reporting nausea symptoms prior to the procedure
Pre-Procedure Cybersickness Symptoms	Immediately pre-procedure (15minutes)	Number of patients in the VR group reporting positive cybersickness symptoms prior to the procedure

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

Arm	Count
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: A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.	17
Standard Care (Control Group) In this arm, patients will receive standard of care with child life specialists during a qualifying medical procedure.	25
Reference Group No virtual reality and no child life specialists; no standardized or formal form of support.	20
Total	62

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Procedure cancelled	1	0	0
Overall Study	VR Malfunction	1	0	0

Baseline characteristics

Characteristic	Virtual Reality Group (Study Group)	Standard Care (Control Group)	Reference Group	Total
Adult Baseline Own Anxiety Level	4.13 score on a scale STANDARD_DEVIATION 3.59	2.95 score on a scale STANDARD_DEVIATION 3.12	0.47 score on a scale STANDARD_DEVIATION 1.12	2.51 score on a scale STANDARD_DEVIATION 3.15
Adult Baseline Perceived Anxiety Level	5.25 score on a scale STANDARD_DEVIATION 2.37	4.65 score on a scale STANDARD_DEVIATION 3.23	2.47 score on a scale STANDARD_DEVIATION 3.71	4.21 score on a scale STANDARD_DEVIATION 3.35
Adult Baseline Perceived Pain Level	4.69 score on a scale STANDARD_DEVIATION 2.68	4.95 score on a scale STANDARD_DEVIATION 3.39	5.44 score on a scale STANDARD_DEVIATION 2.88	5.03 score on a scale STANDARD_DEVIATION 2.99
Age, Customized Child (7-9 years)	3 Participants	2 Participants	4 Participants	9 Participants
Age, Customized Early Adolescent (10-13 years)	7 Participants	9 Participants	3 Participants	19 Participants
Age, Customized Late Adolescent/Adult (18+ years)	1 Participants	7 Participants	4 Participants	12 Participants
Age, Customized Middle Adolescent (14-17 years)	6 Participants	7 Participants	9 Participants	22 Participants
Child Baseline Anxiety Level	3.94 score on a scale STANDARD_DEVIATION 2.56	3.32 score on a scale STANDARD_DEVIATION 3.48	2.00 score on a scale STANDARD_DEVIATION 2.79	3.03 score on a scale STANDARD_DEVIATION 3.08
Child Baseline Pain Level	4.50 score on a scale STANDARD_DEVIATION 2.74	4.56 score on a scale STANDARD_DEVIATION 3.73	4.75 score on a scale STANDARD_DEVIATION 3.46	4.56 score on a scale STANDARD_DEVIATION 3.35
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	2 Participants	0 Participants	4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants	23 Participants	20 Participants	58 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	6 Participants	16 Participants	11 Participants	33 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	2 Participants	1 Participants	5 Participants
Race (NIH/OMB) White	9 Participants	7 Participants	8 Participants	24 Participants
Region of Enrollment United States	17 Participants	25 Participants	20 Participants	62 Participants
Sex: Female, Male Female	11 Participants	13 Participants	12 Participants	36 Participants
Sex: Female, Male Male	6 Participants	12 Participants	8 Participants	26 Participants
Type of Procedure Abscess drainage	0 Participants	1 Participants	0 Participants	1 Participants
Type of Procedure Burn debridement	1 Participants	1 Participants	0 Participants	2 Participants
Type of Procedure Cast Placement	0 Participants	2 Participants	0 Participants	2 Participants
Type of Procedure Laceration repair	1 Participants	1 Participants	0 Participants	2 Participants
Type of Procedure Venipuncture (IV/blood draw)	17 Participants	20 Participants	20 Participants	57 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 19	0 / 25	0 / 20
other Total, other adverse events	3 / 19	4 / 25	4 / 20
serious Total, serious adverse events	0 / 19	0 / 25	0 / 20

Outcome results

Primary

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.