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Smartphone Application in Reducing Dental Anxiety

Primary Purpose

Dental Anxiety

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Tell-Play-Do
Tell-Show-Do
Sponsored by
Hams Hamed Abdelrahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dental Anxiety

Eligibility Criteria

6 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

smart phone application

traditional behavior management technique

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).
Change in heart rate
recorded by using pulse oximeter as a potential secondary measure of anxiety (physiological parameter).

Secondary Outcome Measures

Full Information

First Posted
January 17, 2021
Last Updated
January 20, 2021
Sponsor
Hams Hamed Abdelrahman
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1. Study Identification

Unique Protocol Identification Number
NCT04719299
Brief Title
Smartphone Application in Reducing Dental Anxiety
Official Title
Effectiveness of Smartphone Application in Reducing Anxiety During Pediatric Dental Procedures: a Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 20, 2020 (Actual)
Primary Completion Date
December 27, 2020 (Actual)
Study Completion Date
December 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
smart phone application
Arm Type
Experimental
Arm Description
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.
Arm Title
traditional behavior management technique
Arm Type
Active Comparator
Arm Description
Using traditional behavior management techniques (Tell-Show-Do) which will be applied prior to local anesthesia administration
Intervention Type
Behavioral
Intervention Name(s)
Tell-Play-Do
Intervention Description
Using smart phone application
Intervention Type
Behavioral
Intervention Name(s)
Tell-Show-Do
Intervention Description
Using traditional behavior management technique
Primary Outcome Measure Information:
Title
Change in dental anxiety scores
Description
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).
Time Frame
Baseline and immediate post operative
Title
Change in heart rate
Description
recorded by using pulse oximeter as a potential secondary measure of anxiety (physiological parameter).
Time Frame
Baseline and immediate post operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

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Smartphone Application in Reducing Dental Anxiety

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