Smartphone Application in Reducing Dental Anxiety

NCT ID: NCT04719299

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-20

Study Completion Date

2020-12-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

smart phone application

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.

Group Type EXPERIMENTAL

Tell-Play-Do

Intervention Type BEHAVIORAL

Using smart phone application

traditional behavior management technique

Using traditional behavior management techniques (Tell-Show-Do) which will be applied prior to local anesthesia administration

Group Type ACTIVE_COMPARATOR

Tell-Show-Do

Intervention Type BEHAVIORAL

Using traditional behavior management technique

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tell-Play-Do

Using smart phone application

Intervention Type BEHAVIORAL

Tell-Show-Do

Using traditional behavior management technique

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hams Hamed Abdelrahman

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TPD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dental Game Impact on Kids' Pulpotomy Pain and Anxiety
NCT07072559 ENROLLING_BY_INVITATION NA