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NCT Number: NCT07617662

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

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.

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Key information

Conditions

Pediatric Dental Anxiety Pediatric Dental Pain

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants enrolled in the study will be selected after fulfilling the following inclusion criteria:
  • Healthy six to nine years old.
  • Frankl behavioural rating score 2 during preoperative assessment
  • Bilateral mandibular primary molars indicated for extraction.
  • Written guardian consent.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Basic behavioral management technique

Behavioral

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

Primary outcomes

  1. 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.

  2. 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

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Malak Hazem Zaghloul, BDS

CONTACT

[email protected]

+201009793275

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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