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

September 28, 2026 updated by: Malak Hazem, Alexandria University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Faculty of dentistry Alexandria university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dental anxiety assessment using Facial Image Scale
Time Frame: At baseline (preoperatively) - Immediately after extraction (postoperatively)

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)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dental anxiety assessment using Pulse rate
Time Frame: At baseline (preoperatively) - during injection - during extraction - immediately after extraction (postoperatively)

The pulse rate will be measured using a pulse oximeter
At baseline (preoperatively) - during injection - during extraction - immediately after extraction (postoperatively)
Dental anxiety assessment using Venham's Clinical Anxiety Scale
Time Frame: At baseline (preoperatively) - during needle penetration - during extraction - immediately after extraction (postoperatively)

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 pain assessment using Faces Pain Scale - Revised
Time Frame: Immediately after injection - Immediately after extraction

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
Dental pain assessment using Face, Legs, Activity, Cry, Consolability Scale
Time Frame: During injection - During extraction

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexandria University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Abdelwahab Samaha, PHD, Alexandria University
  • Study Chair: Nadia Aziz Wahba, PHD, Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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