Virtual Reality vs. Standard-of-Care for Comfort During Immunizations in Children

Study Overview
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Brief Summary
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Children need routine immunizations which can be a painful procedure associated with pain and anxiety. This is particularly true of children visiting the children's hospital to visit relatives during flu season. No topical anesthetic or oral analgesia is commonly used. Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain. This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care while receiving immunizations. Investigators will measure pain, anxiety and satisfaction.

Official Title
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A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort During Immunizations in Children

Conditions
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Vaccination

Intervention / Treatment
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* Device: Virtual Reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children age 6 to 16 years Patients arriving to the immunization clinic for immunization. Parents will sign a consent form and children will sign an assent form Exclusion Criteria: Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay) Facial features or injury prohibiting wearing the VR goggles VR system may interfere with immunization

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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<br>Participants are distracted by wearing the virtual reality headset and watching a roller coaster app during immunization. | Device: Virtual Reality<br>* Participants wear a Virtual Reality headset that consists of a ASUS phone and a VOX+ Z3 3D Virtual Reality Headset. The phone runs the VR Roller Coaster app to produce the virtual environment.<br>|
| No Intervention: Control (Standard-of-Care)<br>Participants are distracted with Standard-of-Care by doctors, nurses, nurse practitioners, child life specialists and/or parents. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain using the Faces Pain Scale - Revised | Level of pain as reported by children using Faces Pain Scale - Revised. The scale includes six faces that represent progressively more intense features of pain. Children point to the face that best represents their current level of pain. The minimum score is 0 (representing least pain) and the maximum score is 10 (representing greater pain). The scale increase in increments of 2. | Pain is reported by children immediately following completion of the immunization (within two minutes post-immunization). This scale should take less than one minute to complete. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety using the Venham Situational Anxiety Score | Level of Situational Anxiety as reported by children using the Venham Situational Anxiety Score. This scale includes 8 sets of 2 images of children which represent differing levels of anxiety. Children point to the child that best represents them in that instance. In each set of 2 images of children, one represents greater anxiety (scored as 1) and one represents lesser anxiety (scored as 0). The points from each set of images are totaled. The minimum score is 0 (least anxious) and maximum score is 8 (most anxious). | Anxiety is reported by children immediately following completion of the immunization (within two minutes post-immunization). This scale should take less than one minute to complete. | 
| Patient Satisfaction determined by Global Rating Scale | Satisfaction from the procedure is determined by asking 4 questions on a global rating scale. This scale goes from 0-10 where 0 represents not very much and 10 represents very much. Questions are developed from previous virtual reality research. Overall, how satisfied are you with pain management during plastic surgery? Overall, how satisfied are you with anxiety management during plastic surgery? To what extent did you feel like you went into the virtual world? How much fun did you have while playing in the virtual world? These questions will be analyzed individually not summed. | Satisfaction question is reported by children immediately following completion of the immunization (within 5 minutes post immunization) | 
| Medication Dose | How much topical or local anesthetics are used and when they are used (24 hour time); how much sedatives are used and when they are used (24 hour time); how much analgesics are used and when they are used (24 hour time). | These will be recorded during the procedure and immediately following the procedure using the patient chart | 
| Length of time of procedure | Time in minutes from readiness for procedure (availability of child, staff and equipment) until completion of procedure (healthcare practitioner does not need to touch the patient anymore) | This will be documented during the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Pain, Anxiety