CompletedNot Applicable

Mobile Application Versus Tell-show-do Technique for Improved Behavior Management of Dental Anxiety in Children Aged 7-11 Years: a Multicenter Randomized Control Trial in Karachi-Pakistan

Pakistan114 participantsStarted 2026-02-15

Plain-language summary

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.

Who can participate

Age range

7 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial compared a mobile app to the traditional tell-show-do technique for managing dental anxiety in children aged 7 to 11 — since it's already completed, would the results suggest one approach worked better for reducing anxiety scores and pulse rate, and could either method be used for my child's upcoming dental visits?
2The trial measured anxiety using something called the RMS-PS scale and also tracked pulse rate changes — can you explain what those measurements mean in practical terms, and how we'd know if my child's anxiety improved enough to make dental treatment easier?
3Since this was a randomized controlled trial conducted in Pakistan across multiple centers, how confident are you that the findings would apply to children in our setting, given possible differences in how dental care is delivered or how children respond to these techniques here?
4Tell-show-do is already a commonly used technique in pediatric dentistry — based on what this trial found, do you think a mobile app approach offers enough of an added benefit to try with my child, or is the standard technique still the better starting point?
5If my child's dental anxiety is significant, are there other evidence-based options or specialist referrals we should consider alongside or instead of these behavioral techniques, particularly if the results from this trial showed only modest improvements?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Pulse Rate

Timeframe: Before and immediately after intervention and dental diagnosis procedure (within same visit)

Change in Dental Anxiety Score (RMS-PS)

Timeframe: Before and immediately after intervention and dental diagnostic procedure (within same visit)

Trial details

NCT IDNCT07553156

SponsorAga Khan University Hospital, Pakistan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-20

View on ClinicalTrials.gov More Dental Fear and Anxiety trials