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OpenTrials
Completed

NCT Number: NCT04719299

Smartphone Application in Reducing Dental Anxiety

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.

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Key information

Conditions

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Tell-Play-Do

Behavioral

Using smart phone application

Tell-Show-Do

Behavioral

Using traditional behavior management technique

Primary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 22, 2021
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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