Clinical trial NCT06788301: Dental Anxiety and Pain During Inferior Alveolar Nerve Block in Children: the Effects of Two Distraction Techniques
Official title: The Effects of Virtual Reality and External Cooling and Vibration on Dental Anxiety and Pain During Inferior Alveolar Nerve Block in Children: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Pain
Distraction Methods
Local Anesthesia
Keywords: Dental anxiety
Distraction
Local Anethesia
Pain
Pediatric Dentistry
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 158
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Objectives: To compare the effectiveness of virtual reality (VR) and external cooling and vibration distraction techniques on dental anxiety and pain in children during inferior alveolar nerve block (IANB).

Materials and Methods: This randomized controlled parallel arm trial included 120 children aged between 6-12 years old who required IANB. Children were randomly divided following three groups: Group I: VR eyeglasses, Group II: Buzzy® device, and Group 3: Control (conventional behavior management technique). Dental anxiety levels were measured by the pulse rate and oxygen saturation level before, during, and after IANB procedure. Pain perception during IANB procedure was assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale, Wong Baker Faces Scale (WBS), and Visual Analog Scale (VAS).

Detailed description: This study was designed as a three-arm parallel randomized controlled trial to compare the effects of virtual reality (VR) and external cooling and vibration on dental anxiety and pain during inferior alveolar nerve block (IANB) in children aged 6 to 12 years old.

The sample size consisted of 120 children, and the patients were randomly divided following three different groups: Group I: VR eyeglasses group, Group II: Buzzy® device group, and Group III: Control group.

Group I (VR eylasses): In the present study, 3D VR eyeglasses (Oculus Quest 2, Oculus Go, Facebook Technologies, Auburn, USA) were used for VR distraction.

Group II (Buzzy® device): In the present study, the Buzzy® device (MMJ Labs, Atlanta, GA, USA), consisting of a bee-shaped vibrating body and removable wing-shaped cold gel packs, was used for external cooling and vibration application.

Group III (Control): In the present study, group III received conventional behavior management technique (tell-show-do) during the administration of IANB.

Administration of IANB: The oral mucosa was dried with air-water spray and topical anesthetic solution (Vemcaine %10 Lidocaine, VEM Co. Ltd., Istanbul, Turkey) was applied to the dry mucosa with a cotton pellet for 1 minute. The patient was asked to open his/her mouth as wide as possible, and then IANB was administred using 2 ml of 4% articaine with 1:100.000 adrenaline (Ultracaine DS® Forte, Sanofi Health Products Co. Ltd., Istanbul, Turkey) using an automatic aspirated Aspiject® carpule syringe (RØNVIG Dental Mfg. A/S, Daugaard, Denmark) with a 35 mm 27 gauge needle at a rate of 1 ml/minute. In order to ensure standardisation, each patient received the same dosage of local anesthetic and the IANB procedure was provided by the same investigator.

Dental anxiety and pain assessment In order to evaluate physiological changes associated with anxiety, oxygen saturation (SpO2) and pulse rate (PR) values were recorded using pediatric fingertip pulse oximeter (ChoiceMMed, Beijing Choice Electronic Technology Co., Ltd, China) 1 minutes before, during, and 1 minutes after the administration of IANB.

For objective assessment of pain during the IANB procedure, the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Pain Assessment Scale was used. The FLACC scores were assessed by another investigator not involved in the IANB procedure.

The Wong Baker Face (WBS) and the Visual Analog Scale (VAS), two commonly used and valid pain measurment scale for pediatric patients, were used to assess the self perception of pain. Both scales were explained to the patients, and they were asked to choose the facial expression (for WBS) and the number (for VAS) that best reflected their current level of pain during the IANB procedure.

Eligibility criteria: Inclusion Criteria:

* Children aged between 6-12 years without any systemic disease and physical and/or mental disorders,
* Children whose behavior rating were positive and definitely positive according to the Frankl Behavior Scale (FBS),
* Children with no known allergy to any medication or local anesthetic,
* Children who had mandibular primary/permanent molar requiring dental treatment under an IANB,
* Children with no previous experience of local anesthesia.

Exclusion Criteria:

* Children with systemic disease or neurological behaviour disorders,
* Children whose behavior rating were negative and definitely negative according to the FBS,
* Children with history of allergy to any medication or local anesthetic,
* Children who exhibeted any kind of dento-facial abnormality/syndrome that lead to administration of local anesthesia difficult,
* Children with previous experience of local anesthesia, and non-Turkish speaking

Primary outcomes:
measure: Oxygen saturation
timeFrame: 1 minutes before, during, and 1 minutes after the administration of inferior alveolar nerve block
measure: Pulse rate
timeFrame: 1 minutes before, during, and 1 minutes after the administration of inferior alveolar nerve block
measure: Objective pain assessment
timeFrame: During the inferior alveolar nerve block procedure.
measure: Self perception of pain
timeFrame: Immediately after the inferior alveolar nerve block procedure.
measure: Self perception of pain
timeFrame: Immediately after the inferior alveolar nerve block procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University, Faculty of Dentistry, Department of Pediatric Dentistry
Study officials:
affiliation: Pamukkale University Faculty of Dentistry
name: Arif Bolaca, Dr.
role: STUDY_DIRECTOR
affiliation: Pamukkale University Faculty of Dentistry
name: Aybüke ipek Atik, Dr.
role: PRINCIPAL_INVESTIGATOR
References: