Clinical trial NCT03862573: Virtual Reality vs. Standard-of-Care for Comfort During Dental Procedures in Children
Official title: A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort During Dental Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Procedures
Keywords: Virtual Reality
Pain
Anxiety
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 64
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Post Procedure Pain using the Faces Pain Scale - Revised
timeFrame: 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:
measure: Post Local Anesthetic Pain using the Faces Pain Scale - Revised
timeFrame: 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
measure: Anxiety using the Venham Situational Anxiety Score
timeFrame: 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
measure: Co-operation of the child as measured by the Dentist on 100mm VAS
timeFrame: Co-operation is rated immediately following completion of the dental visit.
measure: Patient Satisfaction determined qualitatively by an open ended question
timeFrame: Satisfaction question is reported by children immediately following completion of the dental procedure
measure: Parent Satisfaction determined qualitatively by an open ended question
timeFrame: Satisfaction question is reported by parents immediately following completion of the dental procedure
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: UBC graduate pediatric dentistry clinic
state: British Columbia
Study officials:
References: