Comparative Evaluation Of The Effectiveness Of Binaural Beats With Cartoons In Alleviating Anxiety In 4 To 8 Year- Old Paediatric Dental Patients: A Randomized Controlled Trial

This randomized controlled clinical study aims to evaluate and compare the effectiveness of two non-pharmacological behavioral interventions—(i) binaural beats combined with cartoons and (ii) only cartoons—in alleviating dental anxiety among pediatric patients aged 4 to 8 years undergoing tooth extraction.

Background & Rationale:

Dental anxiety is a prevalent behavioral barrier in pediatric dentistry, affecting treatment compliance and quality of care. Distraction methods like cartoons (visual) and audio inputs are well-recognized techniques for anxiety reduction. Binaural beats, based on brainwave entrainment using auditory stimuli, represent a novel yet evidence-based method to reduce stress and anxiety. Combining both modalities offers a potentially synergistic effect, which has not been adequately explored in the target ...

Objectives:

• Primary Objective:

To evaluate the effect of binaural beats in reducing dental anxiety in pediatric patients.

• Secondary Objectives:

• To assess changes in physiological indicators (pulse rate) during the intervention.

• To compare the effectiveness of binaural beats with cartoons versus only cartoons.

Study Design:

Open-label, randomized controlled study with two arms:

• Group A (Control): Only visual distraction (cartoons).

• Group B (Intervention): Combined auditory (binaural beats) and visual distraction (cartoons).

Sample Size:

A total of 48 participants (24 per group) calculated using standard formulas to detect a clinically significant difference in anxiety scores with 90 percent power and 5 percent significance.

Study Duration:

18 months (October 2024 to April 2026)

Each subject’s participation will last approximately 12 months.

Inclusion Criteria:

• Children aged 4 to 8 years requiring tooth extraction.

• Frankel Behavior Rating Scale score of 2 or 3.

• Willingness to participate and use headphones/watch cartoons.

Exclusion Criteria:

• Severe behavioral issues (Frankel 1 or 4).

• Epilepsy, hearing impairments, psychiatric illness.

• Prior exposure to binaural beats.

Outcome Measures:

• Venham Picture Test (VPT): A validated pictorial tool for measuring pediatric anxiety.

• Pulse Oximeter Readings: Pulse rate as an objective physiological marker of anxiety.

Statistical Analysis:

Data will be analyzed using SPSS. Paired and unpaired t-tests will be used for intra- and inter-group comparisons. A p-value less than 0.05 will be considered statistically significant.

Ethical Considerations:

• Approved by Institutional Ethics Committee of KGMU, Lucknow.

• Written informed consent from parents and assent from children will be obtained.

• Minimal risk study with no invasive procedures or pharmacological agents.

• Confidentiality and voluntary participation assured.

Funding Source:

Self-funded.

Expected Benefit:

Establishing a safe, non-invasive, and cost-effective behavioral management technique for reducing anxiety in pediatric dental patients, thereby improving cooperation and clinical outcomes.