Brainwave Entrainment Technique in Managing Anxiety and Pain Perception in Pediatric Dental Patients.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brainwave entrainment, Basic behavioral management technique.
- Who it may be relevant to
- Registry conditions: Pediatric Dental Anxiety, Pediatric Dental Pain. Basic parameters: 6 years — 9 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Brainwave Entrainment on Anxiety and Pain Perception in Pediatric Dental Patients (A Randomized Controlled Clinical Trial)
Overview
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.
Interventions
- Device 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 - Behavioral Basic behavioral management technique
Children allocated to this group wil be managed by the basic behavior guidance techniques (Tell-Show-Do).
Primary outcome measures
- Dental anxiety assessment using Venham's Clinical Anxiety Scale [Time frame: At baseline (preoperatively) - during needle penetration - during extraction - immediately after extraction (postoperatively)]
- Dental anxiety assessment using Pulse rate [Time frame: At baseline (preoperatively) - during injection - during extraction - immediately after extraction (postoperatively)]
- Dental pain assessment using Face, Legs, Activity, Cry, Consolability Scale [Time frame: During injection - During extraction]
Secondary outcome measures (2)
- Dental anxiety assessment using Facial Image Scale [Time frame: At baseline (preoperatively) - Immediately after extraction (postoperatively)]
- Dental pain assessment using Faces Pain Scale - Revised [Time frame: Immediately after injection - Immediately after extraction]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of dentistry Alexandria university — Alexandria
Identifiers
NCT: NCT07617662 · 1128-08/2025