Virtual Reality During Procedures in Pediatric Patients

Johns Hopkins University

Status: Terminated

Conditions: Pediatrics; Virtual Reality

Treatments: Other: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT03686176

IRB00161331

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 7 to 26 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 3 patient groups

Virtual Reality Group (Study Group)

Experimental group

Description:

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

Treatment:

Other: Virtual Reality

Active Control Group

No Intervention group

Description:

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 group

Description:

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