Dental Fear and AnxietyNCT07553156
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
A study testing Mobile Application and Tell-Show-Do Technique in people with Dental Fear and Anxiety and Dental Anxiety, run by Aga Khan University Hospital, Pakistan at 3 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Fear and Anxiety, Dental Anxiety
- What is being tested?
- Mobile Application and Tell-Show-Do Technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 3 sitesPakistan
- Study dates
- 15 Feb 2026to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 7-11 years
- Children with no prior experience of dental treatment i.e. FDV (first dental visit).
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Pakistan3 sites
Aga Khan University Hospital
Karachi, Sindh, 74700
Civil Hospital Karachi (CHK)
Karachi, Sindh, 74700
Dow Dental College (DDC)
Karachi, Sindh, 74700
About this study
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.
Read the 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.
- Conditions
- Dental Fear and Anxiety, Dental Anxiety
- Being tested
- Mobile Application, Tell-Show-Do Technique
- Keywords
- Dental anxiety, Pediatric dental anxiety, Mobile application, Tell-show-do, Behavioral management, Randomized controlled trial, Children
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile ApplicationBehavioural
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.
Tell-Show-Do TechniqueBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Tell-Show-Do Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before and immediately after intervention and dental diagnostic procedure (within same visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start15 Feb 2026
- Primary completion20 Apr 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Fear and AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:1 ratio to either the mobile application intervention or the tell-show-do technique.
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Collaborators
- Dow University of Health Sciences, Civil Hospital Karachi
- Responsible party
- Principal investigator, Fasahat Khan, Aga Khan University Hospital, Pakistan
- Investigators
- Shafquat Rozi, PhD, Principal investigator, Community Health Sciences (CHS), Aga Khan University Hospital (AKUH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553156
- Sponsor's protocol ID
- ERC # 11473
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07553156
- Acronym / sponsor ID
- ERC # 11473
- Conditions
- Dental Fear and Anxiety, Dental Anxiety
- Keywords
- Dental anxiety, Pediatric dental anxiety, Mobile application, Tell-show-do, Behavioral management, Randomized controlled trial, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Aga Khan University Hospital, PakistanUniversity, hospital or other
- Collaborators
- Dow University of Health Sciences, Civil Hospital Karachi
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to either the mobile application intervention or the tell-show-do technique.
| Arm | Type | Receives |
|---|---|---|
| Mobile Application | Experimental | Behavioral: Mobile ApplicationA 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. |
| Tell-Show-Do | Active comparator | Behavioral: Tell-Show-Do TechniqueThe 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 |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 7-11 years
- Children with no prior experience of dental treatment i.e. FDV (first dental visit).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile ApplicationA 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. | Behavioural | Mobile Application |
| Tell-Show-Do TechniqueThe conventional tell-show-do behavioral technique is administered for approximately 5 minutes prior to the dental diagnostic procedure to prepare children and reduce anxiety. | Behavioural | Tell-Show-Do |
Primary outcome
Change in Pulse Rate
Time frame: Before and immediately after intervention and dental diagnosis procedure (within same visit)
Pulse rate will be measured three times at one-minute intervals before and after the intervention and averaged to assess change.
Change in Dental Anxiety Score (RMS-PS)
Time frame: Before and immediately after intervention and dental diagnostic procedure (within same visit)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Dental Fear and Anxiety
Not yet recruiting
Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
Postoperative Pain After Endodontic Treatment, Dental Anxiety
Recruiting
Evaluating Operation Calm With Children, Parents, and Clinicians
Preoperative Anxiety Experienced by the Pediatric Patient, Dental Anxiety in Children
Not yet recruiting
Virtual Reality and Point-of-View Video Modeling for Dental Anxiety in Children
Dental Anxiety in Children
Recruiting
Buzzy Bee for Pain and Anxiety Control During Pediatric Dental Local Anesthesia
Anesthesia, Anxiety
Recruiting
Effect of Alpha-Band Binaural Beats on Stress and Recovery in Third Molar Surgery
Dental Anxiety, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shafquat Rozi, PhD principal investigator
Community Health Sciences (CHS), Aga Khan University Hospital (AKUH)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application and Tell-Show-Do Technique in people with Dental Fear and Anxiety and Dental Anxiety, run by Aga Khan University Hospital, Pakistan at 3 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pulse Rate (time frame: Before and immediately after intervention and dental diagnosis procedure (within same visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.