Virtual Reality Pediatric Orthopaedic Outpatient Procedures

Study Overview
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Brief Summary
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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
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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.

Official Title
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Virtual Reality in Reducing Pain and Anxiety in Pediatric Orthopaedics, a Pilot Randomized Controlled Trial

Conditions
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Anxiety, Pain

Intervention / Treatment
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* Device: Virtual Reality


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality (VR)<br>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<br>* A calming virtual reality game will be played<br>|
| No Intervention: No Virtual Reality (VR)<br>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) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Time | Measured with a stopwatch: Start of the procedure defined as the moment the patient completes the first short SAIS, which is shortly upon entering the procedural room. End of the procedure is marked as follows: complete removal of cast (for cast removal), removal of last staple or hardware (staple and hardware removal), removal of needle from final injection site (botox injection) | Intraprocedure | 
| Baxter Retching Faces (BARF) Scale for Nausea | Patients will use the pictorial Baxter Retching Faces Scale (BARF) to measure nausea severity. It is a scale of 0-10 with 6 faces, with the first representing no nausea to the last as experiencing vomiting. This scale has been shown to have construct, content and convergent validity in measuring nausea in children. After the patients have completed the post procedure short SAIS the patients will be asked if they had experienced any feelings of nausea at any point during the procedure. If they answer yes, then they will be asked to rate the nausea using the BARF scale. | Immediately post procedure | 
| State Anxiety Preprocedure | State Anxiety will be measured prior to start of procedure using the Short SAIS (state anxiety inventory scale) which is a shortened version of the Spielberger State Trait Anxiety Inventory (STAI) Scale will be used to collect data on state anxiety. State anxiety refers to the anxiety levels at a particular moment in time. This is in contrast to trait anxiety which is a measure of the tendency of an individual to experience anxiety across different situations. The short SAIS is a six item questionnaire with four possible responses for each item. The total score ranges from 6-24 points, with 6 points indicating no anxiety and 24 points indicating the highest level of anxiety. The total time to complete the questionnaire is approximately five minutes. | Immediately pre-procedure | 
| State Anxiety Postprocedure | State Anxiety will also be measured immediately after completion of the procedure using the Short SAIS (state anxiety inventory scale) which is a shortened version of the Spielberger State Trait Anxiety Inventory (STAI) Scale will be used to collect data on state anxiety. State anxiety refers to the anxiety levels at a particular moment in time. This is in contrast to trait anxiety which is a measure of the tendency of an individual to experience anxiety across different situations. The short SAIS is a six item questionnaire with four possible responses for each item. The total score ranges from 6-24 points, with 6 points indicating no anxiety and 24 points indicating the highest level of anxiety. The total time to complete the questionnaire is approximately five minutes. | Immediately post procedure | 
| Trait Anxiety | The Penn State Worry Questionnaire for Children (PSWQ-C) is a screening tool for assessing generalized anxiety in children aged 7-17 years. It consists of a 14 item self-reported questionnaire. Respondents indicate how often each item applies to them, choosing from the following responses: never, sometimes, often, and always, with points ranging from 0 to 3 for each item. The total score ranges from 0 to 42, with higher scores indicating a greater tendency to worry. The total time to complete the questionnaire is approximately five minutes. | Preprocedure while in the waiting area |