Brainwave Entrainment Technique in Managing Anxiety and Pain Perception in Pediatric Dental Patients.
29. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
34
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Malak Hazem Zaghloul, BDS
- Telefonnummer: +201009793275
- E-post: m.hazem161179.na@alexu.edu.eg
Studiesteder
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Alexandria, Egypt
- faculty of dentistry Alexandria university
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Ta kontakt med:
- Malak Hazem Zaghloul, BDS
- Telefonnummer: +201009793275
- E-post: malakhazem1998@gmail.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Aktiv 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Dental anxiety assessment using Venham's Clinical Anxiety Scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Dental anxiety assessment using Facial Image Scale
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Abdelwahab Samaha, PHD, Alexandria University
- Studiestol: Nadia Aziz Wahba, PHD, Alexandria University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. mai 2026
Primær fullføring (Antatt)
1. august 2026
Studiet fullført (Antatt)
1. oktober 2026
Datoer for studieregistrering
Først innsendt
18. mai 2026
Først innsendt som oppfylte QC-kriteriene
29. mai 2026
Først lagt ut (Faktiske)
1. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 1128-08/2025
Legemiddel- og utstyrsinformasjon, studiedokumenter
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