Virtual Reality During Procedures in Pediatric Patients

NCT03686176 | Terminated Results

• 1 other identifier: IRB00161331
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Virtual Reality; Pediatrics

Outcome Measures

Primary Outcomes (6)

• Change in Patient-Reported Pain During the Procedure

  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.

  Baseline and Immediately post-procedure, up to 15 minutes

• Change in Patient-Reported Anxiety During Procedure

  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.

  Baseline and Immediately post-procedure, up to 15 minutes

• Change in Adult Perceived Pain During the Procedure

  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.

  Baseline and Immediately post-procedure, up to 15 minutes

• 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.

  Baseline and Immediately post-procedure, up to 15 minutes

• Change in Adult's Own Anxiety During the Procedure

  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.

  Baseline and Immediately post-procedure, up to 15 minutes

• Child and Adult Medical Procedure Interaction Scale (CAMPIS) Score

  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).

  Immediately post-procedure, up to 15minutes

Secondary Outcomes (6)

• Duration of Procedure

  Immediately post-procedure, up to 20 minutes

• Ease of Procedure as Assessed by a Likert Scale

  Immediately post-procedure, up to 15 minutes

• Personnel Use for Immobilization

  Immediately post-procedure, up to 15 minutes

• Number of IV or Phlebotomy Attempts

  Immediately post-procedure, up to 15 minutes

• Pre-Procedure Nausea Symptoms

  Immediately pre-procedure (15minutes)

Study Arms (3)

Virtual Reality Group (Study Group)

EXPERIMENTAL

In this arm, patients will receive support from child life specialists plus may use virtual reality simulation goggles during a qualifying medical procedure.

Other: Virtual Reality

Active Control Group

NO INTERVENTION

In this arm, patients will receive standard of care with child life specialists plus distraction of the child's choosing, during a qualifying medical procedure.

External Control (Reference Group)

NO INTERVENTION

No virtual reality and no child life specialists; no standardized or formal form of support.

Interventions

Virtual Reality OTHER

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

Also known as: Oculus Go

Virtual Reality Group (Study Group)

Eligibility Criteria

• Age: 7 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• The Thomas Wilson Sanitarium for Children of Baltimore City: collaborator

Study Sites (1)

Johns Hopkins Children's Center

Baltimore, Maryland, 21212, United States

Location

Related Publications (2)

• 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.

  PMID: 34319249 DERIVED

• 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.

  PMID: 34127486 DERIVED

Limitations and Caveats

Early termination due to the COVID-19 pandemic, small sample size.

Results Point of Contact

• Title: Therese Canares
• Organization: Johns Hopkins University

tcanare1@jhmi.edu

4109964711

Study Officials

• Therese Canares, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, unblinded, controlled

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 26, 2018
• Study Start: July 5, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: August 6, 2020
• Results First Posted: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)