Virtual Reality in Reducing Pain and Anxiety in Pediatric Orthopaedics, a Pilot Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anxiety
- Sponsor
- British Columbia Children's Hospital
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Anxiety (state anxiety intraprocedure)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Bejaan Jivraj
Research Student
British Columbia Children's Hospital
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
Outcomes
Primary Outcomes
Anxiety (state anxiety intraprocedure)
Time Frame: 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.
Wong Baker Scale (WBS) for Procedural Pain
Time Frame: Immediately post procedure
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
Secondary Outcomes
- State Anxiety Postprocedure(Immediately post procedure)
- Trait Anxiety(Preprocedure while in the waiting area)
- Procedural Time(Intraprocedure)
- Baxter Retching Faces (BARF) Scale for Nausea(Immediately post procedure)
- State Anxiety Preprocedure(Immediately pre-procedure)