Clinical trial NCT03686176: Virtual Reality During Procedures in Pediatric Patients
Official title: Virtual Reality During Procedures in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Virtual Reality
Pediatrics
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: The Thomas Wilson Sanitarium for Children of Baltimore City
First posted: 2018-09-26
Enrollment: 64
Sex: ALL
Minimum age (years): 7
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, unblinded, controlled
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Patient-Reported Pain During the Procedure
timeFrame: Baseline and Immediately post-procedure, up to 15 minutes
measure: Change in Patient-Reported Anxiety During Procedure
timeFrame: Baseline and Immediately post-procedure, up to 15 minutes
measure: Change in Adult Perceived Pain During the Procedure
timeFrame: Baseline and Immediately post-procedure, up to 15 minutes
measure: Change in Adult Perceived Anxiety During the Procedure
timeFrame: Baseline and Immediately post-procedure, up to 15 minutes
measure: Change in Adult's Own Anxiety During the Procedure
timeFrame: Baseline and Immediately post-procedure, up to 15 minutes
measure: Child and Adult Medical Procedure Interaction Scale (CAMPIS) Score
timeFrame: Immediately post-procedure, up to 15minutes
Secondary outcomes:
measure: Duration of Procedure
timeFrame: Immediately post-procedure, up to 20 minutes
measure: Ease of Procedure as Assessed by a Likert Scale
timeFrame: Immediately post-procedure, up to 15 minutes
measure: Personnel Use for Immobilization
timeFrame: Immediately post-procedure, up to 15 minutes
measure: Number of IV or Phlebotomy Attempts
timeFrame: Immediately post-procedure, up to 15 minutes
measure: Pre-Procedure Nausea Symptoms
timeFrame: Immediately pre-procedure (15minutes)
measure: Pre-Procedure Cybersickness Symptoms
timeFrame: Immediately pre-procedure (15minutes)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Children's Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Therese Canares, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.