Comparative Evaluation of Virtual Cognitive Distraction and Brainwave Entrainment in Reducing Dental Anxiety in Children Aged 7–12 Years: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Mean change in Facial Image Scale (FIS) score from baseline (pre-procedure, immediately before local anesthesia) to during local anesthesia administration (at the time of injection), comparing Group A (Virtual Cognitive Distraction), Group B (Brainwave Entrainment) and Group C (Standard behaviour management).
Study Overview
Brief Summary
Dental anxiety in children is a common barrier to providing optimal dental care, often resulting in behavioural management challenges and incomplete treatment. Non- pharmacological distraction techniques have been shown to reduce anxiety by diverting the child’s attention from the dental procedure. Among these, Virtual cognitive Distraction using immersive virtual reality ( VR) environments and brainwave entrainment using binural beats are emerging approaches that offer engaging and non-invasive alternatives to conventional methods. This RCT aims to compare the effectiveness of Virtual Cognitive Distraction and Brainwave Entrainment in reducing anxiety among children aged 7-12 years undergoing minimal invasive dental procedures. Fifty-six healthy children meeting the inclusion criteria will be randomly allocated into two groups - group-1 Virtual cognitive distraction and group-2 Brainwave entrainment via headphones.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 7.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Healthy children aged between 7–12 years Cooperative behavior (Frankl rating scale 3 or 4) No history of traumatic dental experiences Child who is visiting the dental clinic for the first time.
Exclusion Criteria
- •Children with neurological, psychological, or developmental disorders Children with visual or auditory impairments Children under medication that may affect mood, behavior, or anxiety levels.
Outcomes
Primary Outcomes
Mean change in Facial Image Scale (FIS) score from baseline (pre-procedure, immediately before local anesthesia) to during local anesthesia administration (at the time of injection), comparing Group A (Virtual Cognitive Distraction), Group B (Brainwave Entrainment) and Group C (Standard behaviour management).
Time Frame: at baseline single visit
Secondary Outcomes
- Mean change in pulse rate (beats per minute) from baseline (pre-procedure) to during the procedure, measured using a pulse oximeter.(Mean change in systolic & diastolic blood pressure (mm Hg) from baseline to during the procedure, measured using an automated BP monitor appropriate for children.)
Investigators
DrAsifa Gazali
Maratha Mandal N G H Institute of Dental Sciences , Belagavi