NCT04719299

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

8 months

First QC Date

January 17, 2021

Last Update Submit

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

EXPERIMENTAL

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

traditional behavior management technique

ACTIVE COMPARATOR

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

Behavioral: Tell-Show-Do

Interventions

Tell-Play-DoBEHAVIORAL

Using smart phone application

smart phone application
Tell-Show-DoBEHAVIORAL

Using traditional behavior management technique

traditional behavior management technique

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Location

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

Locations