Virtual Reality Pediatric Orthopaedic Outpatient Procedures

NCT03784352 | Completed

• 1 other identifier: H18-03184
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study is to evaluate the use of Virtual Reality (VR) in managing pain and anxiety levels during common pediatric orthopaedic outpatient procedures which include: cast application, cast removal, hardware removal (ie. pins and screws), and botox injections.

Conditions

Anxiety; Pain

Outcome Measures

Primary Outcomes (2)

• Wong Baker Scale (WBS) for Procedural Pain

  The WBS is a self-reported outcome measure that asks patients to rate their pain severity by circling the face that best describes the pain on a horizontally positioned VAS with marked end points of "no pain" and "worst possible pain". There are six possible faces with "no pain" representing a score of 0 and "worst pain" representing a score of 10

  Immediately post procedure

• Anxiety (state anxiety intraprocedure)

  Intraprocedural state anxiety will be measured using the The Children's Emotional Manifestation Scale (CEMS) which consists of five categories that include: Facial expression, vocalization, activity, interaction and level of cooperation. A score is obtained by reviewing five descriptions in each category and selecting the number that most clearly represents the observed behavior. Each category is given a score from 1 to 5 for a total score of 5-25. A higher score corresponds to a more distressed child.

  Intraprocedure

Secondary Outcomes (5)

• Procedural Time

  Intraprocedure

• Baxter Retching Faces (BARF) Scale for Nausea

  Immediately post procedure

• State Anxiety Preprocedure

  Immediately pre-procedure

• State Anxiety Postprocedure

  Immediately post procedure

• Trait Anxiety

  Preprocedure while in the waiting area

Study Arms (2)

Virtual Reality (VR)

EXPERIMENTAL

The intervention will consist of standard of care (SOC) in addition to the use of virtual reality. SOC consists of the technician/care provider explaining the procedure while using speech to be comforting and supportive in addition to parent/guardians being allowed to console and distract their child during the procedure and interacting with other distractions techniques that may be available (ie. ipad, or mobile device) Patients assigned to the VR group will interact with VR through mobile-based VR googles.

Device: Virtual Reality

No Virtual Reality (VR)

NO INTERVENTION

This arm will receive regular standard of care (SOC), the same that would be received if they were not enrolled in the study. SOC will include the technician/care provider explaining the procedure while using speech to be comforting and supportive in addition to parent/guardians being allowed to console and distract their child during the procedure and interacting with other distractions techniques that may be available (ie. ipad, or mobile device)

Interventions

Virtual Reality DEVICE

A calming virtual reality game will be played

Virtual Reality (VR)

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• child must be between the ages of 4 and 18 years
• the parent/guardians and child are both able to speak and read English or have a translator be present for them

You may not qualify if:

• symptoms of respiratory or gastrointestinal infection
• visual, auditory, cognitive impairment or developmental delay
• history of seizures or epilepsy

Sponsors & Collaborators

• British Columbia Children's Hospital: lead

Study Sites (1)

British Columbia Children's Hospital

Vancouver, Ontario, V6H3N1, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Kishore Mulpuri, MBBS

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Student

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 21, 2018
• Study Start: February 5, 2019
• Primary Completion: May 10, 2019
• Study Completion: May 17, 2019
• Last Updated: March 2, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)