Virtual Reality for Anxiolysis During Laceration Repair in the Pediatric Emergency Room

Study Overview
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Brief Summary
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The investigators propose a pilot study to examine the feasibility of utilizing immersive virtual reality to reduce procedural anxiety in children undergoing non-facial laceration repair in the Pediatric Emergency Department. The investigators hypothesize that virtual reality will be well-received by patients and their caregivers, and that the anxiety provoked by laceration repair will be mitigated by the immersive virtual reality experience.

Official Title
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A Feasibility Study for the Use of Virtual Reality to Reduce Procedural Anxiety for Children Undergoing Laceration Repair in the Pediatric Emergency Room

Conditions
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Procedural Anxiety, Laceration of Skin

Intervention / Treatment
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* Other: Virtual Reality App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children 5-13 years of age present to ED during the study period with non-facial lacerations patient to undergo wound closure with sutures Exclusion Criteria: Patients with lacerations on the head/face Patients with lacerations sustained in conjunction with loss of consciousness, altered mental status, life-threatening injuries/illness or multi-trauma Patients who sustained a laceration in conjunction with an open fracture Patients with open skin, lice, scabies, or other infectious skin conditions on the head/face Patients with a history of or current symptoms of vertigo Patients who are blind Patients with significant developmental or cognitive delays who may not be able to engage with or tolerate the virtual reality environment, as determined by their parent/caregiver Patients on whom the VR headset does not fit appropriately Non-English speaking patients will be excluded from this study (we do not have funds available to translate the study documents into other languages)

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 13 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtualy Reality App<br>Virtual reality app produced by KindVR played via a stereoscopic head mounted display (Samsung GearVR) and headphones that the patient will wear over their eyes and ears. | Other: Virtual Reality App<br>* Virtual reality app produced by KindVR played via a stereoscopic head mounted display (Samsung GearVR) and headphones that the patient will wear over their eyes and ears.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of children whose anxiety score did NOT increase by ≥ 20mm on a visual analog anxiety scale | Anxiety score will be measured on a Visual Analog Scale. This scale consists of a 100mm line on which parents mark their estimate of their child's anxiety level, with anxiety level increasing from left (0mm) to right (100mm). | from the time of enrollment to the placement of the first stitch, which is typically ranges from 15 to 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety score | Anxiety score will be measured on a Visual Analog Scale. This scale consists of a 100mm line on which parents mark their estimate of their child's anxiety level, with anxiety level increasing from left (0mm) to right (100mm). | from the time of enrollment to wound irrigation, which typically ranges from 5 to 80 minutes | 
| Change in anxiety score | Anxiety score will be measured on a Visual Analog Scale. This scale consists of a 100mm line on which parents mark their estimate of their child's anxiety level, with anxiety level increasing from left (0mm) to right (100mm). | from enrollment to local/regional anesthesia, which typically ranges from 15 to 100 minutes | 
| Change in anxiety score | Anxiety score will be measured on a Visual Analog Scale. This scale consists of a 100mm line on which parents mark their estimate of their child's anxiety level, with anxiety level increasing from left (0mm) to right (100mm). | from enrollment to procedure completion, which typically ranges from 20 to 180 minutes | 
| Patient satisfaction with the use of VR during the procedure as assessed by a patient questionnaire | To assess the receptiveness of patients to this technology as well as the efficacy of the VR experience, participants will be asked to complete a brief questionnaire at the end of the procedure assessing their experience while using VR during the laceration repair. These surveys address the patient's comfort and satisfaction with the technology. We have created separate patient surveys for children ages 5-7 and children ages 8-13 - these surveys have the same questions, but the answer choices are simplified from Likert Rating Scales (scale of 1 - 5) for the older children to a simple Yes, No, I don't know choice for the younger children. There is also a free text response question for which patients can provide additional comments or suggestions regarding their use of VR during laceration repair. | Patients will fill out the questionnaire at the time their sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment | 
| Parent/guardian satisfaction with the use of VR during the procedure as assessed by a parent/guardian questionnaire | To assess the receptiveness of patients to this technology as well as the efficacy of the VR experience, parents/guardians will be asked to complete a brief survey at the end of the procedure assessing their comfort and satisfaction with their child's use of VR during the laceration repair. The survey contains both rating questions with Likert Rating Scales (scale of 1 - 5), yes/no questions, and questions with free text responses. | Parent/guardian will fill out the questionnaire at the time their child's sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment | 
| Provider satisfaction with the use of VR during the procedure as measured by a provider questionnaire | The ED provider who performed the laceration repair will complete a survey at the end of the procedure assessing their satisfaction with using VR during laceration repair. The survey contains yes/no questions, multiple choice questions, and questions with free text responses. | Providers will fill out the questionnaire at the time their patient's sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment | 
| Need for adjunctive anxiolysis methods, sedation, or restraints during the procedure as reported on a provider questionnaire | The ED provider who performed the laceration repair will complete a questionnaire at the end of the procedure which will detail which, if any, adjunctive measures were needed during the procedure. | from enrollment to procedure completion, which typically ranges from 20 to 180 minutes | 
| Headache due to VR use as reported on a qualitative simulator sickness questionnaire | The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain. The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use. | from enrollment to procedure completion, which typically ranges from 20 to 180 minutes | 
| Eye pain due to VR use as reported on a qualitative simulator sickness questionnaire | The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain. The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use. | from enrollment to procedure completion, which typically ranges from 20 to 180 minutes | 
| Nausea due to VR use as reported on a qualitative simulator sickness questionnaire | The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain. The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use. | from enrollment to procedure completion, which typically ranges from 20 to 180 minutes | 
| Dizziness due to VR use as reported on a qualitative simulator sickness questionnaire | The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain. The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use. | from enrollment to procedure completion, which typically ranges from 20 to 180 minutes | 
| Barriers to the use of VR identified during this study as reported on a provider questionnaire | The ED provider who performed the laceration repair will complete a questionnaire at the end of the procedure which will detail which, if any, barriers to the use of VR that they encountered during the procedure | from enrollment to procedure completion, which typically ranges from 20 to 180 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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procedural anxiety, virtual reality, anxiolysis, laceration repair, pediatric