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

A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort During Dental Treatment

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03862573
Enrollment
64
Registered
2019-03-05
Start date
2019-03-31
Completion date
2020-03-31
Last updated
2019-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Procedures

Keywords

Virtual Reality, Pain, Anxiety

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.

Interventions

DEVICEVirtual 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.

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frameDescription
Post Procedure Pain using the Faces Pain Scale - RevisedPain is reported by children immediately following completion of the procedure (within two minutes post-procedure). This scale should take less than one minute to completeLevel 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

MeasureTime frameDescription
Post Local Anesthetic Pain using the Faces Pain Scale - RevisedPain 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 completeLevel 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.
Anxiety using the Venham Situational Anxiety ScoreAnxiety is reported by children immediately following completion of the procedure (within two minutes post-procedure). This scale should take less than one minute to completeLevel 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 VASCo-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.
Patient Satisfaction determined qualitatively by an open ended questionSatisfaction question is reported by children immediately following completion of the dental procedureSatisfaction 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).
Parent Satisfaction determined qualitatively by an open ended questionSatisfaction question is reported by parents immediately following completion of the dental procedureSatisfaction 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).

Countries

Canada

Contacts

Primary ContactRan D. Goldman, MD
rgoldman@cw.bc.ca604-875-2345

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026