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

Not Applicable

• Conditions: Dental Procedures
• Interventions: Device: Virtual Reality

• Registration Number: NCT03862573
• Lead Sponsor: University of British Columbia

Brief Summary

Children sometimes need dental procedures which can be painful and associated with child pain and anxiety. In addition to pain medication, distraction may help children cope with the pain. This may include interacting with books, TV, toys or videogames.

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 (4 - 16 years old) to receive Virtual Reality or standard of care in addition to local anesthetics during dental procedures. Pain, anxiety and satisfaction will be measured as well as the amount of analgesics used and the timing of the procedure. Outcome measures will be compared between the two groups.

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

• Status Verified: 2019-03
• Study First Submitted: 2019-03-02
• Study First Submitted QC: 2019-03-02
• Study First Posted: 2019-03-05
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-13
• Study Start: 2019-03-31
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31

Recruitment & Eligibility

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

Inclusion Criteria

1. Children age 4 to < 17 years
2. Arriving to the UBC dentistry clinic and need dental assessment/procedures
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, autism, challenging communication)
2. Facial features prohibiting wearing the VR goggles
3. Children needing sedation that includes inhalation via a mask (N2O) or IV/IM sedation

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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 the dental procedure

Primary Outcome Measures

Name	Time	Method
Post Procedure Pain using the Faces Pain Scale - Revised	Pain is reported by children immediately following completion of the procedure (within two minutes post-procedure). 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
Post Local Anesthetic Pain using the Faces Pain Scale - Revised	Pain is reported by children immediately following injection of the local anesthetic (within two minutes post-injection). 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.
Parent Satisfaction determined qualitatively by an open ended question	Satisfaction question is reported by parents immediately following completion of the dental procedure	Satisfaction from the procedure is determined qualitatively. Parents are asked "What is your opinion on how the procedure went?" Answers will be recorded in writing and be assessed for themes (similar words, positive or negative language).
Patient Satisfaction determined qualitatively by an open ended question	Satisfaction question is reported by children immediately following completion of the dental procedure	Satisfaction from the procedure is determined qualitatively. Children are asked "What is your opinion on how the procedure went?" Answers will be recorded in writing and be assessed for themes (similar words, positive or negative language).
Anxiety using the Venham Situational Anxiety Score	Anxiety is reported by children immediately following completion of the procedure (within two minutes post-procedure). 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).
Co-operation of the child as measured by the Dentist on 100mm VAS	Co-operation is rated immediately following completion of the dental visit.	The dentist will rate their impression of the level of co-operation by the child on a 100 mm VAS.

Trial Locations

Locations (1)

UBC graduate pediatric dentistry clinic; 🇨🇦 Vancouver, British Columbia, Canada