Efficacy of Virtual Reality in Reducing Injection Pain and Anxiety During Local Anesthesia in Children

Plovdiv Medical University

Status

Completed

Conditions

Local Anesthesia

Injection Pain

Treatments

Device: Local anesthesia with conventional syringe + VR device

Procedure: Local anesthesia with conventional syringe

Study type

Interventional

Funder types

Other

Identifiers

NCT03772483

PlovdivMU2

Details and patient eligibility

About

The aim of this study is to determine the efficacy of a virtual reality (VR) device in reducing injection pain and anxiety associated with local anesthesia in pediatric dental patients.

The clinical trial is a randomized split-mouth assignment. Included patients are 8-12 years old requiring local anesthetic infiltration with conventional syringe (CS) for conservative treatment of two primary maxillary molars bilaterally.

Eligible patients undergo two single-visit treatments after CFSS-DS measurement before each, whereas VR is allocated to either first or second local anesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on visual analogue scale (VAS). Secondary outcome measures: self-reported anxiety during injection on FIS; pain-related behavior according to FLACC scale; heart-rate dynamics; patient preference to local anesthesia method - CS or CS+VR.

Full description

Achieving local anesthesia in children is one of the critical aspects of pain management.

A contemporary engaging form of distraction is represented by virtual reality devices. Virtual reality (VR) devices create a virtual environment of view and sound that allow patients to be immersed in an interactive, simulated world to distract them from pain. The VR devices have a wide viewing field and three-dimensional displays that project the images right in front of the user. They not only show potentially attractive audio-visual stimuli, but also exclude all other visual environmental stimuli that may affect the patient.

The aim of this study is to determine the efficacy of a virtual reality (VR) device in reducing injection pain and anxiety associated with local anesthesia in pediatric dental patients.

The device used in this study is Noon VR, FXGear, compatible with a mobile phone.

The clinical trial is a randomized split-mouth assignment. Included patients are healthy positive children 8-12 years old requiring local anesthetic infiltration for conservative treatment of two primary maxillary molars bilaterally.

Eligible patients undergo two single-visit treatments after measurement of dental fear prior to each according to the Dental Subscale of the Children's Fear Survey Schedule (CFSS-DS). Local anesthetic is delivered through buccal infiltration with conventional syringe, where as the virtual reality distraction is allocated to either first or second local anesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on visual analogue scale. Secondary outcome measures: self-reported anxiety during injection on Facial Image Scale; pain-related behavior according to Faces, Legs, Activity, Cry, Consolability (FLACC) scale; heart-rate dynamics; patient preference to local anesthesia method - traditional infiltration or virtual reality device-assisted injection.

Enrollment

40 patients

Sex

All

Ages

8 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients, identified as positive or definitely positive through Frankl behavioral rating scale.
Children, requiring local anesthesia infiltration for conservative treatment of two primary upper jaw molars bilaterally.
Children without previous experience with local anesthesia for dental treatment.
Obtained informed consent from parents or gave-givers to participate in the study.

Exclusion criteria

Children who are considered medically compromised or medically complex patients. The absence of disease is confirmed by anamnestic interview with a parent or a care-giver of the child and excludes general acute or chronic disease, cognitive impairment, psychogenic non-epileptic events, sensitivity to flashing light or motion.
Vision requiring correction with eyeglasses.
Recent injury to the eyes or face that prevents comfortable use of VR hardware or software.
Patients who are undergoing therapy with neurological, sedative, analgesic and/or anti-inflammatory drugs 7 days prior to treatment.
Patients with allergy to local anesthetics of the amide group.
Children, who are first time ever dental patients.