This study aims to compare the effectiveness of a mobile application versus the conventional tell-show-do (TSD) technique in reducing dental anxiety among children aged 7-11 years attending their first dental visit. The study is a multicenter randomized controlled trial conducted at tertiary care dental hospitals in Karachi, Pakistan. Participants are randomly assigned to either a mobile application-based behavioral intervention or the TSD technique prior to a dental diagnostic procedure. The primary outcomes include changes in pulse rate and anxiety levels measured using the Raghavendra Madhuri Sujata Pictorial Scale (RMS-PS) before and after the intervention. The findings of this study will help determine whether mobile-based behavioral tools can improve anxiety management in pediatric dental settings.

Dental anxiety is a common barrier to effective dental care in children and may lead to avoidance of treatment and poor oral health outcomes. Conventional behavioral management techniques such as tell-show-do (TSD) are widely used; however, the increasing availability of digital tools provides an opportunity to enhance patient preparation and reduce anxiety.

This study is a multicenter, open-label, randomized controlled trial conducted at tertiary care dental hospitals in Karachi, Pakistan. Children aged 7-11 years presenting for their first dental visit are enrolled and randomly allocated to either a mobile application-based behavioral intervention or the conventional TSD technique. The intervention is delivered for a standardized duration prior to a dental diagnostic procedure.

The primary outcomes include changes in pulse rate and anxiety levels assessed using the Raghavendra Madhuri Sujata Pictorial Scale (RMS-PS), measured before and after the intervention. Pulse rate is recorded three times at one-minute intervals at each time point and averaged. Secondary analyses include comparison of outcomes between intervention groups.

The study aims to evaluate whether a mobile application can serve as an effective alternative to traditional behavioral techniques in reducing dental anxiety among children in clinical settings.

Inclusion Criteria:

• Children aged 7-11 years
• Children with no prior experience of dental treatment i.e. FDV (first dental visit).

Exclusion Criteria:

• Children with any systematic or mental disorder (given the challenges in communication and participation, children with special needs or serious systemic conditions should be prioritized for appropriate care rather than extending their time in the trial)
• Children who are physically handicapped
• Children who are undergoing medical treatment or taking any medication that affects the heart rate (it will affect our outcome measure of pulse rate)
• Children with heart rate related disorders (which could introduce bias to the heart rate results).
• Children with significant language barriers or special needs that prevent proper communication and understanding.

Individual participant data (IPD) sharing plans are currently undecided. De-identified data may be shared in the future upon reasonable request, subject to institutional policies and ethical approval.