Brainwave Entrainment Technique in Managing Anxiety and Pain Perception in Pediatric Dental Patients.
29 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
34
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Malak Hazem Zaghloul, BDS
- Número de teléfono: +201009793275
- Correo electrónico: m.hazem161179.na@alexu.edu.eg
Ubicaciones de estudio
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Alexandria, Egipto
- faculty of dentistry Alexandria university
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Contacto:
- Malak Hazem Zaghloul, BDS
- Número de teléfono: +201009793275
- Correo electrónico: malakhazem1998@gmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Dental anxiety assessment using Venham's Clinical Anxiety Scale
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Dental anxiety assessment using Facial Image Scale
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Abdelwahab Samaha, PHD, Alexandria University
- Silla de estudio: Nadia Aziz Wahba, PHD, Alexandria University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de mayo de 2026
Finalización primaria (Estimado)
1 de agosto de 2026
Finalización del estudio (Estimado)
1 de octubre de 2026
Fechas de registro del estudio
Enviado por primera vez
18 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de mayo de 2026
Publicado por primera vez (Actual)
1 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 1128-08/2025
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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