Dental Anxiety and Pain During Inferior Alveolar Nerve Block in Children: the Effects of Two Distraction Techniques

Pamukkale University

Status: Completed

Conditions: Dental Anxiety; Distraction Methods; Local Anesthesia; Pain

Treatments: Device: VR eyeglasses; Device: Buzzy device; Procedure: Inferior Alveolar Nerve Block

Study type: Interventional

Funder types: Other

Identifiers

NCT06788301

2022DİŞF003

Details and patient eligibility

About

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).

Full 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.

Enrollment: 158 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 3 patient groups

Group I (VR eyeglasses)

Experimental group

Description:

In the VR group, patients wore a VR eyeglasses (Oculus Quest 2, Oculustm Go, Facebook Technologies, Auburn, USA) and watched a previously selected favorite cartoon during the IANB procedure.

Treatment:

Procedure: Inferior Alveolar Nerve Block

Device: VR eyeglasses

Group II (Buzzy device)

Experimental group

Description:

In the Buzzy device group, the Buzzy® device (MMJ Labs, Atlanta, GA, USA) was placed extra-orally on the site of IANB (right/left mandibula) during the administration of IANB.

Treatment:

Procedure: Inferior Alveolar Nerve Block

Device: Buzzy device

Group III (Control)

Other group

Description:

In the control group, patients received conventional behavior management technique (tell-show-do) during the administration of IANB. Prior to the IANB procedure, the instruments to be used and procedure were explained to the patient in phrases suitable for the patient's cognitive level.

Treatment:

Procedure: Inferior Alveolar Nerve Block