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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Brainwave entrainment
  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
• Поведенческое Basic behavioral management technique
  Children allocated to this group wil be managed by the basic behavior guidance techniques (Tell-Show-Do).

Первичные конечные точки

• Dental anxiety assessment using Venham's Clinical Anxiety Scale [Срок оценки: At baseline (preoperatively) - during needle penetration - during extraction - immediately after extraction (postoperatively)]
• Dental anxiety assessment using Pulse rate [Срок оценки: At baseline (preoperatively) - during injection - during extraction - immediately after extraction (postoperatively)]
• Dental pain assessment using Face, Legs, Activity, Cry, Consolability Scale [Срок оценки: During injection - During extraction]

Вторичные конечные точки (2)

• Dental anxiety assessment using Facial Image Scale [Срок оценки: At baseline (preoperatively) - Immediately after extraction (postoperatively)]
• Dental pain assessment using Faces Pain Scale - Revised [Срок оценки: Immediately after injection - Immediately after extraction]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of dentistry Alexandria university — Alexandria

Идентификаторы

NCT: NCT07617662 · 1128-08/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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