Virtual Reality Goggle Utilization for Venipuncture Distraction

Study Overview
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Brief Summary
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This is a randomized non-blinded trial evaluating the effect of virtual reality goggles on perceived pain and anxiety scores during venipuncture on hospitalized children ages 5-21. We will randomized patients to either standard of care (including Lidocaine 2.5%/Prilocaine 2.5% cream as a topical anesthetic 60-240 minutes prior to venipuncture) or standard of care plus virtual reality goggles.

Detailed Description
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Study personnel will identify patients on CHAM 6 and CHAM 8 scheduled for lab draw prior to child life rounds and subsequently ask the health care providers if there are any patients that are not developmentally or physically appropriate to use the VR equipment. They will then screen and consent the patients approximately 1 hour prior to the Child Life rounds (see appendix A & B). Patients aged 12-17 years old who are able to read the form will be asked to fill out an assent form (see appendix C) and patients aged 5-12 years old and those unable to read the form will be read the assent form to ensure verbal assent. Those patients who consent to the study will be randomized to a VR arm and non VR arm using computer generated randomization. Lidocaine 2.5%/Prilocaine 2.5% cream will be placed on all patients that have consented to the study by the patient's nurse if they don't already have it applied. After consent and assurance of topical anesthetic application, a brief demographic questionnaire (see appendix D) will also be completed. For efficiency and feasibility, two study personnel will screen and consent families, assist with VR set up and removal, and conduct post procedure assessment.

Official Title
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Optimizing the Patient Experience: Virtual Reality Goggle Utilization for Venipuncture Distraction - Can we Decrease Anxiety and Pain During This Common Procedure?

Conditions
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Pain, Procedural

Intervention / Treatment
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* Device: Virtual Reality Goggles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients aged 5-21 years old admitted to the 6th floor of the inpatient unit who are scheduled for a venipuncture during morning phlebotomy rounds Exclusion Criteria: Patients developmentally or physically not appropriate to use the VR equipment as determined by their parent, guardian or healthcare provider, if there is discomfort related to wearing the goggles (for example: recent neurosurgery, migraines, hardware on head), patient have photosensitive seizures or infectious concern such as scabies, lice, COVID-19 that can't reliably be disinfected. Patient (>18) or Parent or guardian (for patient < 18) that does not speak English, Spanish or Arabic will be excluded. If patient refuses Lidocaine 2.5%/Prilocaine 2.5% cream use they will also be excluded from the study. -

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 21 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized non blinded study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR goggle with venipuncture<br>Virtual reality goggles SamsungGearVR supplied by KindVR will be placed on patients at least 2 min prior to venipuncture. All patients will also receive Lidocaine 2.5%/Prilocaine 2.5% cream at least 60 min prior to venipuncture. | Device: Virtual Reality Goggles<br>* Virtual reality goggles will placed at least 2 min prior to venipuncture to deteremine if it mitigates perceived anxiety or perceived pain scores.<br>|
| No Intervention: no VR goggle with venipuncture<br>Patients will receive Lidocaine 2.5%/Prilocaine 2.5% cream at least 60 min prior to venipuncture but NO virtual reality goggles. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Perceived Pain: scale | change in the perceived pain using Wong-Baker FACES scale pre/post venipuncture. Faces scale converts 6 faces to numbers (0, 2,4,6,8,10) with high number indicating worse pain. | Approximately 1 hour prior to venipuncture and again immediately after venipuncture. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Scores | Changed in pre/post venipuncture anxiety scores using visual analogue scale where patients mark on a scale their value from 0-100mm. | Approximately 1 hour prior to venipuncture and again immediately after venipuncture. | 
| Heart Rate | Change in HR for patients on cardiac monitor pre/post venipuncture | Approximately 1 hour prior to venipuncture and again immediate after venipuncture. | 
| Level of simulator sickness | Level of simulator sickness with immersive VR distraction during venipuncture using serum sickness survey (4 questions 0-10 asking degree of head hurt, eye hurt, upset stomach and dizziness with 10 being worse outcome) | Approximately 1 hour prior to venipuncture and again immediately after venipuncture | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality