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

Effectiveness of Brainwave Entrainment on Anxiety and Pain Perception in Pediatric Dental Patients (A Randomized Controlled Clinical Trial)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Dental Anxiety; Pediatric Dental Pain
• Intervention / Treatment: Device: Brainwave entrainment; Behavioral: Basic behavioral management technique

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Malak Hazem Zaghloul, BDS; Phone Number: +201009793275; Email: m.hazem161179.na@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of dentistry Alexandria university
    • Contact: Malak Hazem Zaghloul, BDS; Phone Number: +201009793275; Email: malakhazem1998@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants enrolled in the study will be selected after fulfilling the following inclusion criteria:

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

Exclusion Criteria:

• Children with:

  1. Physical disabilities or psychiatric disorders
  2. Epilepsy.
  3. Visual or hearing disabilities
  4. On photophobia inducing or hearing altering medications.
  5. Hypersensitivity to local anesthetic drugs used.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: brainwave entrainment group; 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; 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.
Active Comparator: Basic behavior management technique; Children allocated to this group wil be managed by the basic behavior guidance techniques (Tell-Show-Do).	Behavioral: Basic behavioral management technique; Children allocated to this group wil be managed by the basic behavior guidance techniques (Tell-Show-Do).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental anxiety assessment using Facial Image Scale	The FIS comprises one item with a response set of five faces (ranging from a very sad to a very smiley face). Children will be asked to indicate which of the faces they feel most like at that moment, it is a 'state' measure of anxiety that provides an immediate reflection of how the child is feeling.	At baseline (preoperatively) - Immediately after extraction (postoperatively)
Dental pain assessment using Faces Pain Scale - Revised	The Faces pain scale - Revised features 6 gender neutral faces arranged horizontally, showing increasing levels of pain from "no pain" (leftmost face, scored as 0) to "very much pain" (rightmost face, scored as 10). Children will be asked to point to the face that best matches their pain level.	Immediately after injection - Immediately after extraction

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Director: Abdelwahab Samaha, PHD, Alexandria University; Study Chair: Nadia Aziz Wahba, PHD, Alexandria University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1128-08/2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No