Smartphone Application in Reducing Dental Anxiety

• ClinicalTrials.gov Identifier: NCT04719299
• Recruitment Status: Completed
• First Posted: January 22, 2021
• Last Update Posted: January 22, 2021
• Sponsor: Hams Hamed Abdelrahman
• Information provided by (Responsible Party): Hams Hamed Abdelrahman, Alexandria University

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
Dental Anxiety	Behavioral: Tell-Play-Do; Behavioral: Tell-Show-Do	Not Applicable

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 (Clinical Trial)
• 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: April 20, 2020
• Actual Primary Completion Date: December 27, 2020
• Actual Study Completion Date: December 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 [ 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).

Eligibility Criteria

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

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).

Contacts and Locations

Locations

Egypt

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Sponsors and Collaborators

Hams Hamed Abdelrahman

More Information

• 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: January 22, 2021
• Last Update Posted: January 22, 2021
• Last Verified: January 2021

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

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders