Clinical trial NCT03784352: Virtual Reality Pediatric Orthopaedic Outpatient Procedures
Official title: Virtual Reality in Reducing Pain and Anxiety in Pediatric Orthopaedics, a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Pain
Lead sponsor: British Columbia Children's Hospital
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 110
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Wong Baker Scale (WBS) for Procedural Pain
timeFrame: Immediately post procedure
measure: Anxiety (state anxiety intraprocedure)
timeFrame: Intraprocedure
Secondary outcomes:
measure: Procedural Time
timeFrame: Intraprocedure
measure: Baxter Retching Faces (BARF) Scale for Nausea
timeFrame: Immediately post procedure
measure: State Anxiety Preprocedure
timeFrame: Immediately pre-procedure
measure: State Anxiety Postprocedure
timeFrame: Immediately post procedure
measure: Trait Anxiety
timeFrame: Preprocedure while in the waiting area
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: Ontario
Study officials:
affiliation: University of British Columbia
name: Kishore Mulpuri, MBBS
role: PRINCIPAL_INVESTIGATOR
References: