Brainwave Entrainment Technique in Managing Anxiety and Pain Perception in Pediatric Dental Patients.
29 mei 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
34
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Malak Hazem Zaghloul, BDS
- Telefoonnummer: +201009793275
- E-mail: m.hazem161179.na@alexu.edu.eg
Studie Locaties
-
-
-
Alexandria, Egypte
- faculty of dentistry Alexandria university
-
Contact:
- Malak Hazem Zaghloul, BDS
- Telefoonnummer: +201009793275
- E-mail: malakhazem1998@gmail.com
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
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.
|
|
Actieve vergelijker: Basic behavior management technique
Children allocated to this group wil be managed by the basic behavior guidance techniques (Tell-Show-Do).
|
Children allocated to this group wil be managed by the basic behavior guidance techniques (Tell-Show-Do).
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Dental anxiety assessment using Venham's Clinical Anxiety Scale
Tijdsspanne: 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 anxiety assessment using Pulse rate
Tijdsspanne: 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 pain assessment using Face, Legs, Activity, Cry, Consolability Scale
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Dental anxiety assessment using Facial Image Scale
Tijdsspanne: 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)
|
|
Dental pain assessment using Faces Pain Scale - Revised
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Abdelwahab Samaha, PHD, Alexandria University
- Studie stoel: Nadia Aziz Wahba, PHD, Alexandria University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 mei 2026
Primaire voltooiing (Geschat)
1 augustus 2026
Studie voltooiing (Geschat)
1 oktober 2026
Studieregistratiedata
Eerst ingediend
18 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
29 mei 2026
Eerst geplaatst (Werkelijk)
1 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
1 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
29 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 1128-08/2025
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .