Virtual Reality Pediatric Orthopaedic Outpatient Procedures

NCT ID: NCT03784352

Last Updated: 2020-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-05
• Study Completion Date: 2019-05-17

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.

Detailed Description

Immediately following recruitment, demographic data and diseased related information (ie. location of cast/hardware, reason for cast/hardware placement and location and reason for botox injection) will be collected through self and/or guardian report. All data will be collected using REDCap (research electronic data capture). Using a parallel group design, patients will then be stratified by age (4-7, 8-12 and 13-18 years), gender, and procedure classifications (hardware or cast or staple or suture removal or cast application or botox injection) site of hardware or cast or staple or suture or botox injection), and reason for the procedure (trauma vs a preexisting orthopaedic condition). After randomization by the REDCap system, patients are taken into the procedure room where a questionnaire (Short STAI) is completed by the patient to collect pre-procedural state anxiety measurements. Following this, patients in the control group will receive standard of care (SOC) which allows for the technician and/or accompanying guardian to try and distract and or console the patient as they normally would. The patients in the intervention group will receive SOC with Virtual Reality (VR) interaction a few minutes before, during and following the procedure (around 5-10minutes total). During the procedure the researcher will complete an observational survey (CEMS) to assess procedural state anxiety. Upon completion, both groups will then be asked to complete a survey (Short STAI) to collect post-procedural anxiety levels and an additional survey (Wong Baker Scale) to retrospectively collect pain levels from during the procedure and their current pain levels post procedure while parent/guardians and cast technician will be asked to complete their respective satisfaction questionnaires. Following this, the child will be asked if they experienced any nausea at any point during the procedure, if they did, they will be asked to complete the BARF questionnaire to measure the amount of nausea experienced. Following completion of questionnaires, patients who were in the control group are invited to interact with the VR simulation for a total of 5 minutes. This was chosen to incentivize recruitment for the study.

SOC will consist 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.

Conditions

Anxiety; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual Reality (VR)

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.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: DEVICE

A calming virtual reality game will be played

No Virtual Reality (VR)

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality

A calming virtual reality game will be played

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

British Columbia Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bejaan Jivraj

Research Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kishore Mulpuri, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

British Columbia Children's Hospital

Vancouver, Ontario, Canada

Countries

Canada

Other Identifiers

H18-03184

Identifier Type: -

Identifier Source: org_study_id