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

NCT07553156 | Completed

• 1 other identifier: ERC # 11473
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Dental Anxiety; Dental Fear and Anxiety

Keywords

Dental anxiety; Pediatric dental anxiety; Mobile application; Tell-show-do; Behavioral management; Randomized controlled trial; Children

Outcome Measures

Primary Outcomes (2)

• Change in Pulse Rate

  Pulse rate will be measured three times at one-minute intervals before and after the intervention and averaged to assess change.

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

• Change in Dental Anxiety Score (RMS-PS)

  Dental anxiety will be assessed using the Raghavendra Madhuri Sujata Pictorial Scale (RMS-PS) before and after the intervention. A validated child-friendly anxiety scale based on facial expressions.

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

Study Arms (2)

Mobile Application

EXPERIMENTAL

A mobile application named Dentist Games will be used as an intervention, the permission to use is obtained from the developers. This mobile application has various dental treatments as games for children to play and virtually act as a dentist and perform dental treatments such as scaling, dental filling, extraction and application of local anesthesia.

Behavioral: Mobile Application

Tell-Show-Do

ACTIVE COMPARATOR

The control group will receive tell-show-do (TSD) technique. This technique involves a structured sequence where children are initially informed about the impending procedure(tell), followed by the presentation of dental instruments to familiarize them(show), and culminating in a demonstration of the procedure itself in an easily comprehensible manner(do). The TSD will be given for 5 minutes by the dentist

Behavioral: Tell-Show-Do Technique

Interventions

Mobile Application BEHAVIORAL

A mobile application-based behavioral intervention is provided for approximately 5 minutes prior to the dental diagnostic procedure to familiarize children with the dental environment and reduce anxiety.

Mobile Application

Tell-Show-Do Technique BEHAVIORAL

The conventional tell-show-do behavioral technique is administered for approximately 5 minutes prior to the dental diagnostic procedure to prepare children and reduce anxiety.

Tell-Show-Do

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University Hospital, Pakistan: lead
• Dow University of Health Sciences: collaborator
• Civil Hospital Karachi: collaborator

Study Sites (3)

Aga Khan University Hospital

Karachi, Sindh, 74700, Pakistan

Location

Civil Hospital Karachi (CHK)

Karachi, Sindh, 74700, Pakistan

Location

Dow Dental College (DDC)

Karachi, Sindh, 74700, Pakistan

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Shafquat Rozi, PhD

  Community Health Sciences (CHS), Aga Khan University Hospital (AKUH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Student, Department of Community Health Sciences, Aga Khan University

Model Details: Participants are randomly assigned in a 1:1 ratio to either the mobile application intervention or the tell-show-do technique.

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 27, 2026
• Study Start: February 15, 2026
• Primary Completion: April 20, 2026
• Study Completion: April 20, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

PA (3)