Brainwave Entrainment Technique in Managing Anxiety and Pain Perception in Pediatric Dental Patients.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-9
SponsorAlexandria University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Healthy six to nine years old.
Frankl behavioural rating score 2 during preoperative assessment
Bilateral mandibular primary molars indicated for extraction.
Written guardian consent.
Disqualifiers
Physical disabilities or psychiatric disorders
Epilepsy.
Visual or hearing disabilities
On photophobia inducing or hearing altering medications.
Trial design
Design model
Parallel
Treatments tested in this trial
Brainwave entrainment
DeviceChildren 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.
Basic behavioral management technique
BehavioralChildren allocated to this group wil be managed by the basic behavior guidance techniques (Tell-Show-Do).
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: brainwave entrainment groupExperimental treatment 1 intervention
Group B: Basic behavior management techniqueActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Dental anxiety assessment using Venham's Clinical Anxiety Scale
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.
Time frame
At baseline (preoperatively) - during needle penetration - during extraction - immediately after extraction (postoperatively)2
Dental anxiety assessment using Pulse rate
The pulse rate will be measured using a pulse oximeter
Time frame
At baseline (preoperatively) - during injection - during extraction - immediately after extraction (postoperatively)3
Dental pain assessment using Face, Legs, Activity, Cry, Consolability Scale
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.
Time frame
During injection - During extractionSecondary outcomes
1
Dental anxiety assessment using Facial Image Scale
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.
Time frame
At baseline (preoperatively) - Immediately after extraction (postoperatively)2
Dental pain assessment using Faces Pain Scale - Revised
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.
Time frame
Immediately after injection - Immediately after extractionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: