Virtual Reality-based Distraction to Reduce Distress in the Pediatric Emergency Department

NCT04291404 | Completed

• 1 other identifier: Pro00095418
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Needle procedures, such as intravenous (IV) insertions, are among the most commonly performed procedures for children needing medical care. IV insertions are often a painful and stressful experience for both children and their parents/ caregivers. Pediatric pain and distress that is not adequately treated may lead to a frightened and uncooperative child, repeated IV attempts and overall frustration with care for the family and clinical team. Distraction therapy is a common psychological strategy which involves engaging children in a cognitive task or activity in order to divert attention away from painful stimuli. Given children's growing enthusiasm for novel technology, the investigators propose that an immersive virtual reality (VR) experience may provide an effective means of distraction for children undergoing IV insertions.

Conditions

Children Requiring IV Placement

Keywords

Pain; Distress; Virtual Reality; Distraction Therapy

Outcome Measures

Primary Outcomes (1)

• Child's total distress score during the IV procedure

  Two RAs will independently observe a videotape of each child and use the Observational Scale of Behavioral Distress - Revised (OSBD-R) to assess children's response behaviors to pain. (0 = no distress, 23.5 = maximum distress)

  During the IV placement procedure

Secondary Outcomes (8)

• Child's pain score during the IV procedure

  Immediately after IV placement

• Child's Fear

  Immediately after IV placement

• Parental anxiety

  Immediately after IV placement

• Parent/ Caregiver Satisfaction

  Immediately following the IV procedure

• Nurse Satisfaction

  Immediately following the IV procedure

Study Arms (2)

Standard of Care (Control) Arm

NO INTERVENTION

Standard of care treatment, which may include a combination of the following, at the discretion of the treating team and family: parent/ caregiver support, child life services, healthcare provider support, etc.

Intervention Arm

EXPERIMENTAL

Addition of distraction via an immersive, interactive VR experience to Standard of Care

Device: Virtual Reality Distraction

Interventions

Virtual Reality Distraction DEVICE

Distraction therapy using a Virtual Reality (VR) device

Intervention Arm

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• child aged 6-17 years
• requires IV placement
• will receive topical anesthetic cream for IV placement

You may not qualify if:

• medically unstable (CTAS 1, requires immediate IV insertion)
• unconscious or not fully alert
• visual, auditory or cognitive or mental health issues precluding safe interaction with the VR intervention
• conditions that could be exacerbated by the VR environment (as reported by the family), such as: (i) current symptomatic nausea / vomiting / dizziness / migraine; (ii) history of psychosis / hallucinations / epilepsy
• presence of an infection / injury which could contaminate the VR intervention equipment (as determined by the healthcare team) including but not limited to: (i) open wounds / infections of the head and neck area; (ii) suspected or confirmed methicillin-resistant Staphylococcus aureus (MRSA) colonization
• screens positive for 'influenza-like illness' (ILI) as per the current SCH ED screening criteria
• child or parental language barrier precluding the ability to understand and complete study assessments, in the absence of a native language translator
• previous enrollment in this study

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, Canada

Location

Related Publications (2)

• Ali S, Hudson S, Rajagopal M, Stinson JN, Gourlay K, Ma K, Candelaria P, Vandermeer B, Felkar B, Schreiner K, Proctor A, Hartling L. A Randomized Controlled Trial of Commercially Available Virtual Reality for Intravenous Cannulation-Related Distress in Children. J Pediatr. 2026 Jan;288:114803. doi: 10.1016/j.jpeds.2025.114803. Epub 2025 Sep 15.

  PMID: 40962105 DERIVED

• Ali S, Rajagopal M, Stinson J, Ma K, Vandermeer B, Felkar B, Schreiner K, Proctor A, Plume J, Hartling L. Virtual reality-based distraction for intravenous insertion-related distress in children: a study protocol for a randomised controlled trial. BMJ Open. 2022 Mar 30;12(3):e057892. doi: 10.1136/bmjopen-2021-057892.

  PMID: 35354617 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Samina Ali, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: March 2, 2020
• Study Start: September 28, 2020
• Primary Completion: February 12, 2022
• Study Completion: February 12, 2022
• Last Updated: March 31, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)