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

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.

Study Overview

• Status: Completed
• Conditions: Dental Anxiety; Dental Fear and Anxiety
• Intervention / Treatment: Behavioral: Mobile Application; Behavioral: Tell-Show-Do Technique

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74700
      • Aga Khan University Hospital
    • Karachi, Sindh, Pakistan, 74700
      • Civil Hospital Karachi (CHK)
    • Karachi, Sindh, Pakistan, 74700
      • Dow Dental College (DDC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile Application; 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; 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.
Active Comparator: Tell-Show-Do; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Aga Khan University Hospital, Pakistan
• Collaborators: Dow University of Health Sciences; Civil Hospital Karachi
• Investigators: Principal Investigator: Shafquat Rozi, PhD, Community Health Sciences (CHS), Aga Khan University Hospital (AKUH)

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2026
• Primary Completion (Actual): April 20, 2026
• Study Completion (Actual): April 20, 2026

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Children; Mobile application; Dental anxiety; Pediatric dental anxiety; Tell-show-do; Behavioral management
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: ERC # 11473

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No