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

Vaccination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03693469
• Other study ID #: H18-01851
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: January 2019
• Source: University of British Columbia
• Contact: Ran Goldman, MD
• Phone: 604-875-2345
• Email: rgoldman[@]cw.bc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Vaccination

Intervention

Device:
• Virtual Reality
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.

Locations

Country	Name	City	State
Canada	BC Children's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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)
Secondary	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
Secondary	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