Virtual Reality During Procedures in Pediatric Patients

Not Applicable

Terminated

Conditions: Virtual Reality
Pediatrics

Interventions: Other: Virtual Reality

Registration Number: NCT03686176

Lead Sponsor: Johns Hopkins University

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 64

Inclusion Criteria

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
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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Group (Study Group)	Virtual Reality	In this arm, patients will receive support from child life specialists plus may use virtual reality simulation goggles during a qualifying medical procedure.

Primary Outcome Measures

Name	Time	Method
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.
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 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 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.
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).

Secondary Outcome Measures

Name	Time	Method
Pre-Procedure Cybersickness Symptoms	Immediately pre-procedure (15minutes)	Number of patients in the VR group reporting positive cybersickness symptoms prior to the procedure
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