Smartphone Application in Reducing Dental Anxiety

Sponsor
Hams Hamed Abdelrahman (Other)
Overall Status
Completed
CT.gov ID
NCT04719299
Collaborator
(none)
78
1
2
8.2
9.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Tell-Play-Do
  • Behavioral: Tell-Show-Do
N/A

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

Study Type:
Interventional
Actual Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effectiveness of Smartphone Application in Reducing Anxiety During Pediatric Dental Procedures: a Controlled Clinical Study
Actual Study Start Date :
Apr 20, 2020
Actual Primary Completion Date :
Dec 27, 2020
Actual Study Completion Date :
Dec 27, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: Tell-Play-Do
Using smart phone application

Active Comparator: traditional behavior management technique

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

Behavioral: Tell-Show-Do
Using traditional behavior management technique

Outcome Measures

Primary Outcome Measures

  1. Change in dental anxiety scores [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 [Baseline and immediate post operative]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 8 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry, Alexandria University Alexandria Egypt

Sponsors and Collaborators

  • Hams Hamed Abdelrahman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria University
ClinicalTrials.gov Identifier:
NCT04719299
Other Study ID Numbers:
  • TPD
First Posted:
Jan 22, 2021
Last Update Posted:
Jan 22, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 22, 2021