Clinical trial NCT03772483: Efficacy of Virtual Reality in Reducing Injection Pain and Anxiety During Local Anesthesia in Children
Official title: Efficacy of Virtual Reality Distraction in Reducing Injection Pain and Anxiety During Local Anesthesia in Pediatric Dental Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injection Pain
Local Anesthesia
Keywords: virtual reality
pain control
pediatric dental patients
pediatric pain management
local anesthesia children
Lead sponsor: Plovdiv Medical University
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized Intervention Model: Split-mouth assignment
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain felt during injection using visual analogue scale
timeFrame: Immediately after local anesthetic delivery
Secondary outcomes:
measure: Pain-related behavior evaluated on the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale
timeFrame: During local anesthesia procedure
measure: Self-reported anxiety during injection evaluated on FIS
timeFrame: Immediately after local anesthetic delivery
measure: Heart rate dynamics of the patient
timeFrame: Start: in the waiting room, at least 5 minutes before local anaesthesia procedure. End: at least 5 minutes after treatment.
measure: Assessment of self-reported dental fear on CFSS-DS questionnaire
timeFrame: At least 5 minutes before local anesthesia
measure: Patient preference to local anesthesia method
timeFrame: One week after second procedure
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: Department of Pediatric Dentistry, Faculty of Dental Medicine
Study officials:
affiliation: Plovdiv Medical University
name: Elitsa Veneva, DMD
role: PRINCIPAL_INVESTIGATOR
References: