Brainwave Entrainment Technique in Managing Anxiety and Pain Perception in Pediatric Dental Patients.

NCT07617662 | Not Yet Recruiting

• 1 other identifier: 1128-08/2025
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Pediatric dental anxiety and pain management present significant clinical challenges during routine treatment. While conventional behavior management techniques exist, their inconsistent effectiveness necessitates the continuous search for alternative solutions. Brainwave entrainment (BWE) , a novel approach using audiovisual stimuli to induce relaxing alpha waves (8-12 Hz) , shows promise in anxiety and pain management. However, its application in pediatric dentistry remains insufficiently explored, particularly for invasive dental procedures.

Conditions

Pediatric Dental Anxiety; Pediatric Dental Pain

Outcome Measures

Primary Outcomes (3)

• Dental anxiety assessment using Venham's Clinical Anxiety Scale

  VCAS rates the child's anxiety into 6 categories with scores ranging from 0 to 5. A score of 0 means low anxiety and a score of 5 refers to debilitating anxiety so much so that the child is out of contact with the reality of the threat and the requirement of physical restraint. The operator will assign a score to each child based on the child's response by analvsis of the recorded videotape.

  At baseline (preoperatively) - during needle penetration - during extraction - immediately after extraction (postoperatively)

• Dental anxiety assessment using Pulse rate

  The pulse rate will be measured using a pulse oximeter

  At baseline (preoperatively) - during injection - during extraction - immediately after extraction (postoperatively)

• Dental pain assessment using Face, Legs, Activity, Cry, Consolability Scale

  It evaluates 5 behavioral categories namely Face, Legs, Activity, Cry, Consolability. Each category is scored 0-2, yielding a total pain score of 0-10 (higher = more severe pain). The operator will assign a score to each category based on the child's response by analysis of the recorded videotape.

  During injection - During extraction

Secondary Outcomes (2)

• Dental anxiety assessment using Facial Image Scale

  At baseline (preoperatively) - Immediately after extraction (postoperatively)

• Dental pain assessment using Faces Pain Scale - Revised

  Immediately after injection - Immediately after extraction

Study Arms (2)

brainwave entrainment group

EXPERIMENTAL

Children allocated to this group will undergo 5.5 minutes of brainwave entrainment before dental treatment. This will be delivered through a headset and a multicolored eyeset compatible with smartphones with eyes closed.The entrainment device will be introduced to the children and the parents. The children will be given time to accommodate with the device before starting theprocedure and will undergo an entrainment stimulation. The frequency will be set at 10 Hz and the volume level will be set around 60dB to ensure uniformity among participants. However patients will have the option to modify the volume settings if they encounter discomfort.

Device: Brainwave entrainment

Basic behavior management technique

ACTIVE COMPARATOR

Children allocated to this group wil be managed by the basic behavior guidance techniques (Tell-Show-Do).

Behavioral: Basic behavioral management technique

Interventions

Brainwave entrainment DEVICE

Children allocated ot this group will undergo 5.5 minutes of brainwave entrainment before dental treatment. This will be delivered through a headset and a multicolored eyeset compatible with smartphones with eyes closed.The entrainment device will be introduced to the children and the parents. The children will be given time to accommodate with the device before starting theprocedure and will undergo an entrainment stimulation. The frequency will be set at 10 Hz and the volume level will be set around 60dB to ensure uniformity among participants. However patients will have the option to modify the volume settings if they encounter discomfort.

brainwave entrainment group

Basic behavioral management technique BEHAVIORAL

Children allocated to this group wil be managed by the basic behavior guidance techniques (Tell-Show-Do).

Basic behavior management technique

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy six to nine years old.
• Frankl behavioural rating score 2 during preoperative assessment
• Bilateral mandibular primary molars indicated for extraction.
• Written guardian consent.

You may not qualify if:

• Children with:
• Physical disabilities or psychiatric disorders
• Epilepsy.
• Visual or hearing disabilities
• On photophobia inducing or hearing altering medications.
• Hypersensitivity to local anesthetic drugs used.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of dentistry Alexandria university

Alexandria, Egypt

Location

Study Officials

• Abdelwahab Samaha, PHD

  Alexandria University

  STUDY DIRECTOR

• Nadia Aziz Wahba, PHD

  Alexandria University

  STUDY CHAIR

Central Study Contacts

Malak Hazem Zaghloul, BDS

CONTACT

+201009793275; m.hazem161179.na@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical instructor of Pediatric Dentistry

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 1, 2026
• Study Start: May 1, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

EG (1)