Smartphone Application in Reducing Dental Anxiety

Dental Anxiety Clinical Trial

Official title:

Effectiveness of Smartphone Application in Reducing Anxiety During Pediatric Dental Procedures: a Controlled Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04719299
• Other study ID #: TPD
• Status: Completed
• Phase: N/A
• Start date: April 20, 2020
• Est. completion date: December 27, 2020

Study information

• Verified date: January 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 27, 2020
• Est. primary completion date: December 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Children with previous dental experience.
• Medically compromised children.
• Children with special needs (physical or mental).

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety

Intervention

Behavioral:
• Tell-Play-Do
Using smart phone application
• Tell-Show-Do
Using traditional behavior management technique

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and immediate post operative
Primary	Change in heart rate	recorded by using pulse oximeter as a potential secondary measure of anxiety (physiological parameter).	Baseline and immediate post operative