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

NCT06788301 | Completed

• 1 other identifier: 2022DİŞF003
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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).

Conditions

Dental Anxiety; Pain; Distraction Methods; Local Anesthesia

Keywords

Dental anxiety; Distraction; Local Anethesia; Pain; Pediatric Dentistry

Outcome Measures

Primary Outcomes (5)

• Oxygen saturation

  The physiological response of dental anxiety to inferior alveolar nerve block was evaluated by parameters of oxygen saturation value.

  1 minutes before, during, and 1 minutes after the administration of inferior alveolar nerve block

• Pulse rate

  The physiological response of dental anxiety to inferior alveolar nerve block was evaluated by parameters of pulse rate value.

  1 minutes before, during, and 1 minutes after the administration of inferior alveolar nerve block

• Objective pain assessment

  For objective assessment of pain during the inferior alveolar nerve block procedure, the Face, Legs, Activity, Cry, Consolability Behavioral Pain Assessment Scale (0-10) was used. (0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-10: severe pain)

  During the inferior alveolar nerve block procedure.

• Self perception of pain

  The Wong Baker Face Scale (0-10) was used to assess the self perception of pain. (0: no pain, 10: severe pain)

  Immediately after the inferior alveolar nerve block procedure.

• Self perception of pain

  The Visual Analog Scale (0-10) was used to assess the self perception of pain. (0: no pain, 10: severe pain)

  Immediately after the inferior alveolar nerve block procedure.

Study Arms (3)

Group I (VR eyeglasses)

EXPERIMENTAL

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.

Procedure: Inferior Alveolar Nerve Block; Device: VR eyeglasses

Group II (Buzzy device)

EXPERIMENTAL

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.

Procedure: Inferior Alveolar Nerve Block; Device: Buzzy device

Group III (Control)

OTHER

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.

Procedure: Inferior Alveolar Nerve Block

Interventions

Inferior Alveolar Nerve Block PROCEDURE

local anesthesia administration (inferior alveolar nerve block)

Group I (VR eyeglasses); Group II (Buzzy device); Group III (Control)

VR eyeglasses DEVICE

VR eyeglasses was used to distarct patients from dental environment during inferior alveolar nerve block.

Group I (VR eyeglasses)

Buzzy device DEVICE

Buzzy device was used to distarct patients from dental environment during inferior alveolar nerve block.

Group II (Buzzy device)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University, Faculty of Dentistry, Department of Pediatric Dentistry

Denizli, 20160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arif Bolaca, Dr.

  Pamukkale University Faculty of Dentistry

  STUDY DIRECTOR

• Aybüke ipek Atik, Dr.

  Pamukkale University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 23, 2025
• Study Start: July 20, 2022
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)