Dental AnxietyNCT04719299
Smartphone Application in Reducing Dental Anxiety
A study testing Tell-Play-Do and Tell-Show-Do in people with Dental Anxiety, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
evaluating the effectiveness of smartphone applications (Tell-Play-Do) (TPD) in reduction of preoperative anxiety in children undergoing restorative treatment, as measured by heart rate and Venham's Picture Test. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Tell-Play-Do and Tell-Show-Do
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2020to 27 Dec 2020
- 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 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- School-age children aged from 6-8 years.
- Presence of carious primary molars without pulpal involvement.
- Parents have the ability to write, read and willingness to participate in the study.
- First dental visit to the clinic.
- Normal healthy children.
Who cannot join
- Children with previous dental experience.
- Medically compromised children.
- Children with special needs (physical or mental).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Smartphone Application in Reducing Anxiety During Pediatric Dental Procedures: a Controlled Clinical Study
evaluating the effectiveness of smartphone applications (Tell-Play-Do) (TPD) in reduction of preoperative anxiety in children undergoing restorative treatment, as measured by heart rate and Venham's Picture Test.
Read the detailed description
A total of at least 78 patients aged from 6-8 years will be included. All participants will be divided equally into two groups. Study group TPD using smartphone application and Control group (Tell-Show-Do) (TSD) using traditional behavior management technique.
Dental anxiety using Venham's Picture Test and heart rate using pulse oximeter will be assessed during dental treatment
- Conditions
- Dental Anxiety
- Being tested
- Tell-Play-Do, Tell-Show-Do
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tell-Play-DoBehavioural
Using smart phone application
Tell-Show-DoBehavioural
Using traditional behavior management technique
| Study group | Role | What they receive |
|---|---|---|
| smart phone application | Experimental | Behavior modification of patients will be done by showing them smartphone application game. The game demonstrates the use of common dental equipment like mirrors, ultrasonic scalers, handpieces and suction tips, etc. in the form of animated pictures with visual and sound effects. The dentist will play the game to show the child the dental procedure that will be performed on him later. Receives: Behavioral: Tell-Play-Do |
| traditional behavior management technique | Active comparator | Using traditional behavior management techniques (Tell-Show-Do) which will be applied prior to local anesthesia administration Receives: Behavioral: Tell-Show-Do |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dental anxiety scores
The number of times the "anxious" figure will be chosen a score of one will be assigned and then totaled to give a final score (minimum score - zero; maximum score - eight) for each patient.
The final score will be interpreted as follow: 8 (Very high anxiety), Equal to or more than 6 and less than 8 (High anxiety), Equal to or more than 4 and less than 6 (Average), Equal to or more than 2 and less than 4 (Low anxiety), More than 0 and less than 2 (Very low anxiety) and 0 (No anxiety).
Measured: Baseline and immediate post operative
Change in heart rate
recorded by using pulse oximeter as a potential secondary measure of anxiety (physiological parameter).
Measured: Baseline and immediate post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start20 Apr 2020
- Primary completion27 Dec 2020
- Study completion27 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719299
- Sponsor's protocol ID
- TPD
- Status last verified
- Jan 2021
- First submitted
- 17 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Smartphone Application in Reducing Anxiety During Pediatric Dental Procedures: a Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04719299
- Acronym / sponsor ID
- TPD
- Conditions
- Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 27 Dec 2020 (actual)
- Study completion
- 27 Dec 2020 (actual)
- First posted
- 22 Jan 2021 (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.
evaluating the effectiveness of smartphone applications (Tell-Play-Do) (TPD) in reduction of preoperative anxiety in children undergoing restorative treatment, as measured by heart rate and Venham's Picture Test.
Detailed description
A total of at least 78 patients aged from 6-8 years will be included. All participants will be divided equally into two groups. Study group TPD using smartphone application and Control group (Tell-Show-Do) (TSD) using traditional behavior management technique.
Dental anxiety using Venham's Picture Test and heart rate using pulse oximeter will be assessed during dental treatment
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| smart phone application | Experimental | Behavioral: Tell-Play-DoBehavior modification of patients will be done by showing them smartphone application game. The game demonstrates the use of common dental equipment like mirrors, ultrasonic scalers, handpieces and suction tips, etc. in the form of animated pictures with visual and sound effects. The dentist will play the game to show the child the dental procedure that will be performed on him later. |
| traditional behavior management technique | Active comparator | Behavioral: Tell-Show-DoUsing traditional behavior management techniques (Tell-Show-Do) which will be applied prior to local anesthesia administration |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- School-age children aged from 6-8 years.
- Presence of carious primary molars without pulpal involvement.
- Parents have the ability to write, read and willingness to participate in the study.
- First dental visit to the clinic.
- Normal healthy children.
Key exclusion criteria (3 listed)
- Children with previous dental experience.
- Medically compromised children.
- Children with special needs (physical or mental).
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 |
|---|---|---|
| Tell-Play-DoUsing smart phone application | Behavioural | smart phone application |
| Tell-Show-DoUsing traditional behavior management technique | Behavioural | traditional behavior management technique |
Primary outcome
Change in dental anxiety scores
Time frame: Baseline and immediate post operative
The number of times the "anxious" figure will be chosen a score of one will be assigned and then totaled to give a final score (minimum score - zero; maximum score - eight) for each patient. The final score will be interpreted as follow: 8 (Very high anxiety), Equal to or more than 6 and less than 8 (High anxiety), Equal to or more than 4 and less than 6 (Average), Equal to or more than 2 and less than 4 (Low anxiety), More than 0 and less than 2 (Very low anxiety) and 0 (No anxiety).
Change in heart rate
Time frame: Baseline and immediate post operative
recorded by using pulse oximeter as a potential secondary measure of anxiety (physiological parameter).
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 22 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tell-Play-Do and Tell-Show-Do in people with Dental Anxiety, run by Hams Hamed Abdelrahman at 1 site in Egypt.
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 5 inclusion and 3 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 dental anxiety scores (time frame: Baseline and immediate post operative). 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 22 Jan 2021.