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| Name | Class |
|---|---|
| KindVR | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtualy Reality App | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality App | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel M Fein, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital at Montefiore | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35934650 | Derived | Nemetski SM, Berman DI, Khine H, Fein DM. Virtual Reality as Anxiolysis During Laceration Repair in the Pediatric Emergency Department. J Emerg Med. 2022 Jul;63(1):72-82. doi: 10.1016/j.jemermed.2022.01.025. Epub 2022 Aug 5. |
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| 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 |