Brainwave Entrainment Technique in Managing Anxiety and Pain Perception in Pediatric Dental Patients.
29. Mai 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
34
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Malak Hazem Zaghloul, BDS
- Telefonnummer: +201009793275
- E-Mail: m.hazem161179.na@alexu.edu.eg
Studienorte
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Alexandria, Ägypten
- faculty of dentistry Alexandria university
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Kontakt:
- Malak Hazem Zaghloul, BDS
- Telefonnummer: +201009793275
- E-Mail: malakhazem1998@gmail.com
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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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.
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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.
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Aktiver Komparator: Basic behavior management technique
Children allocated to this group wil be managed by the basic behavior guidance techniques (Tell-Show-Do).
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Children allocated to this group wil be managed by the basic behavior guidance techniques (Tell-Show-Do).
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Dental anxiety assessment using Venham's Clinical Anxiety Scale
Zeitfenster: At baseline (preoperatively) - during needle penetration - during extraction - immediately after extraction (postoperatively)
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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.
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At baseline (preoperatively) - during needle penetration - during extraction - immediately after extraction (postoperatively)
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Dental anxiety assessment using Pulse rate
Zeitfenster: At baseline (preoperatively) - during injection - during extraction - immediately after extraction (postoperatively)
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The pulse rate will be measured using a pulse oximeter
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At baseline (preoperatively) - during injection - during extraction - immediately after extraction (postoperatively)
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Dental pain assessment using Face, Legs, Activity, Cry, Consolability Scale
Zeitfenster: During injection - During extraction
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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.
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During injection - During extraction
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Dental anxiety assessment using Facial Image Scale
Zeitfenster: At baseline (preoperatively) - Immediately after extraction (postoperatively)
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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.
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At baseline (preoperatively) - Immediately after extraction (postoperatively)
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Dental pain assessment using Faces Pain Scale - Revised
Zeitfenster: Immediately after injection - Immediately after extraction
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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.
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Immediately after injection - Immediately after extraction
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: Abdelwahab Samaha, PHD, Alexandria University
- Studienstuhl: Nadia Aziz Wahba, PHD, Alexandria University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Mai 2026
Primärer Abschluss (Geschätzt)
1. August 2026
Studienabschluss (Geschätzt)
1. Oktober 2026
Studienanmeldedaten
Zuerst eingereicht
18. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
29. Mai 2026
Zuerst gepostet (Tatsächlich)
1. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
1. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
29. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 1128-08/2025
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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