Smartphone Application in Reducing Dental Anxiety
Effectiveness of Smartphone Application in Reducing Anxiety During Pediatric Dental Procedures: a Controlled Clinical Study
1 other identifier
interventional
78
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 27, 2020
CompletedFirst Submitted
Initial submission to the registry
January 17, 2021
CompletedFirst Posted
Study publicly available on registry
January 22, 2021
CompletedJanuary 22, 2021
January 1, 2021
8 months
January 17, 2021
January 20, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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).
Baseline and immediate post operative
Change in heart rate
recorded by using pulse oximeter as a potential secondary measure of anxiety (physiological parameter).
Baseline and immediate post operative
Study Arms (2)
smart phone application
EXPERIMENTALBehavior 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.
traditional behavior management technique
ACTIVE COMPARATORUsing traditional behavior management techniques (Tell-Show-Do) which will be applied prior to local anesthesia administration
Interventions
Using traditional behavior management technique
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Children with previous dental experience.
- Medically compromised children.
- Children with special needs (physical or mental).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry, Alexandria University
Alexandria, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant lecturer of DPH and Clinical statistician
Study Record Dates
First Submitted
January 17, 2021
First Posted
January 22, 2021
Study Start
April 20, 2020
Primary Completion
December 27, 2020
Study Completion
December 27, 2020
Last Updated
January 22, 2021
Record last verified: 2021-01