Clinical trial NCT04585061: A Novel Approach in Reducing Dental Pain and Anxiety of Pediatric Patient During Local Anesthesia.
Official title: A Novel Approach in Reducing Dental Pain and Anxiety of Pediatric Patient During Local Anesthesia. A Clinical Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Pain
Lead sponsor: Riyadh Elm University
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 31
Sex: ALL
Minimum age (years): 5
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 sweet in compare to 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 5 - 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 sweet is allocated to first local anesthesia procedure and VR is allocated to 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+sweet or CS+VR.

Detailed description: Achieving local anesthesia in children is one of the critical aspects of pain management and they effect the quality of treatment as well as behavior of child.

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.

While sweet-tasting reduce signs of pain during painful procedures. This effect is considered to be mediated both by the release of endorphins and by a pre absorptive mechanism related to the sweet taste.

The aim of this study is to determine the efficacy of sweet-testing compare to 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 Harga Miniso Vr Glass 3d terbaru, compatible with a mobile phone.

The sweet used is xylitol tablet The clinical trial is a randomized split-mouth assignment. Included patients are healthy positive children 5-12 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 is the sweet-test applied with first local anesthesia procedure and the virtual reality distraction is allocated to 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 - sweet test 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, xylitol.
* 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: Baseline (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
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: AbdulRahman Alasmari
Study officials:
affiliation: Riyadh Elm University
name: AbdulRahman Alasmari, Resident
role: PRINCIPAL_INVESTIGATOR
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