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

NCT ID: NCT03862573

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-31
• Study Completion Date: 2020-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual Reality

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

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: 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.

Control (Standard of Care)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Ran Goldman

Professor and Co-head of the Division of Clinical Pharmacology, Division of Emergency Medicine, Department of Pediatrics; Investigator, BC Children's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UBC graduate pediatric dentistry clinic

Vancouver, British Columbia, Canada

Countries

Canada

Central Contacts

Ran D. Goldman, MD

Role: CONTACT

rgoldman@cw.bc.ca

604-875-2345 ext. 7333

Facility Contacts

Ran D. Goldman, MD

Role: primary

rgoldman@cw.bc.ca

604-875-2345 ext. 7333

Other Identifiers

H19-00486

Identifier Type: -

Identifier Source: org_study_id