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

NCT03862573 | Unknown

• 1 other identifier: H19-00486
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Procedures

Keywords

Virtual Reality; Pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• Post Procedure 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 procedure (within two minutes post-procedure). This scale should take less than one minute to complete

Secondary Outcomes (5)

• 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

• 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

• Co-operation of the child as measured by the Dentist on 100mm VAS

  Co-operation is rated immediately following completion of the dental visit.

• Patient Satisfaction determined qualitatively by an open ended question

  Satisfaction question is reported by children immediately following completion of the dental procedure

• Parent Satisfaction determined qualitatively by an open ended question

  Satisfaction question is reported by parents immediately following completion of the dental procedure

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Participants are distracted by wearing the virtual reality headset and watching a roller coaster app during the dental procedure

Device: Virtual Reality

Control (Standard of Care)

NO INTERVENTION

Participants are distracted with Standard-of-Care by dentists and/or parents.

Interventions

Virtual Reality DEVICE

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.

Virtual Reality

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children age 4 to \< 17 years
• Arriving to the UBC dentistry clinic and need dental assessment/procedures
• Parents will sign a consent form and children will sign an assent form

You may not qualify if:

• Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, challenging communication)
• Facial features prohibiting wearing the VR goggles
• Children needing sedation that includes inhalation via a mask (N2O) or IV/IM sedation

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

UBC graduate pediatric dentistry clinic

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Ran D. Goldman, MD

CONTACT

604-875-2345; rgoldman@cw.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Co-head of the Division of Clinical Pharmacology, Division of Emergency Medicine, Department of Pediatrics; Investigator, BC Children's Hospital

Study Record Dates

• First Submitted: March 2, 2019
• First Posted: March 5, 2019
• Study Start: March 31, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

CA (1)