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

Not Applicable

• Conditions: Vaccination
• Interventions: Device: Virtual Reality

• Registration Number: NCT03693469
• Lead Sponsor: University of British Columbia

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-30
• Study Start: 2018-10-01
• Study First Posted: 2018-10-03
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-18
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Children age 6 to 16 years
2. Patients arriving to the immunization clinic for immunization.
3. Parents will sign a consent form and children will sign an assent form

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Exclusion Criteria

1. Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay)
2. Facial features or injury prohibiting wearing the VR goggles
3. VR system may interfere with immunization

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality	Virtual Reality	Participants are distracted by wearing the virtual reality headset and watching a roller coaster app during immunization.

Primary Outcome Measures

Name	Time	Method
Pain using the Faces Pain Scale - Revised	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.	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.

Secondary Outcome Measures

Name	Time	Method
Anxiety using the Venham Situational Anxiety Score	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.	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).
Medication Dose	These will be recorded during the procedure and immediately following the procedure using the patient chart	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).
Length of time of procedure	This will be documented during the 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)
Patient Satisfaction determined by Global Rating Scale	Satisfaction question is reported by children immediately following completion of the immunization (within 5 minutes post immunization)	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.

Trial Locations

Locations (1)

BC Children's Hospital; 🇨🇦 Vancouver, British Columbia, Canada