NCT03907514

Brief Summary

The aim of the present study is to assess the impact of a digital tool on the interaction between the dentist and the adolescent patient, concerning the level of dental anxiety and communication. To achieve this purpose, a Randomized Controlled Clinical Trial will be performed using a short version of e-SAID (Survey of Anxiety and Information for Dentists) in Portuguese (FALE). That is, the intervention to be tested is an application usage, which will contain a questionnaire with questions supposedly made by the dentist, about feelings regarding the dental appointment and preferences for coping with dental treatment. Thus, the use of this digital tool aims to facilitate communication, favoring the adolescent-dentist relationship, and establishing empathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 4, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2019

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

8 months

First QC Date

January 31, 2019

Last Update Submit

February 15, 2020

Conditions

Keywords

Technology Assessment, HealthDental anxietyAdolescentClinical Trial

Outcome Measures

Primary Outcomes (1)

  • Changes in adolescent patient's level of dental anxiety through the FALE application.

    Changes in patient's level of dental anxiety will be obtained through the question: "How do you feel about coming to see your dentist today?". This question is inserted in the FALE application and is answered through a seven-point face scale.

    The outcome measure will be assessed before a single dental appointment in two stages: at the beginning and after four minutes, in the end of the "FALE" application use.

Study Arms (2)

Intervention Group (IG)

EXPERIMENTAL

The adolescents in this group will use the "FALE" application through a smartphone in the waiting room before the dental appointment. When starting to answer the application, the adolescent will report his/her level of dental anxiety through the question, "How do you feel about coming to see your dentist today?", and record his/her answer on a seven-point face scale. Then the participant will continue to answer the 12 other questions, and finally registers his/her anxiety level once more through the same question.

Behavioral: "FALE" Application

Control Group (CG)

NO INTERVENTION

Similarly to IG, the adolescents in this group will use the "FALE" application through a smartphone, but only to record their level of anxiety by answering the question "How do you feel about coming to see your dentist today?" using a seven-point face scale. Instead of continuing to answer the other questions, the application will guide him to wait for the one-minute interval (expected time to answer the questionnaire) and, once more, ask the same question regarding his/her feeling about the experience with the dentist.

Interventions

"FALE" is a digital tool, in the form of an application for smartphones, which aims to demonstrate empathy and facilitate communication between the adolescent patient and the dentist. The application contains 14 questions regarding dental anxiety, feelings and patient coping preferences regarding dental care.

Intervention Group (IG)

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Brazilian adolescents literate in Portuguese
  • Brazilian adolescents able to use smartphone

You may not qualify if:

  • Adolescents with intellectual, sensory or physical disabilities
  • Adolescents not capable to read and write/type

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Pernambuco

Recife, Pernambuco, 50670-901, Brazil

Location

Related Publications (3)

  • Yee R, Jones LM, Hosey MT. What the child "SAID" to the dentist: A UK randomized controlled trial. Child Care Health Dev. 2017 Nov;43(6):926-932. doi: 10.1111/cch.12510. Epub 2017 Aug 30.

    PMID: 28857237BACKGROUND
  • Jones L. Validation and randomized control trial of the e-SAID, a computerized paediatric dental patient request form, to intervene in dental anxiety. Child Care Health Dev. 2015 Jul;41(4):620-5. doi: 10.1111/cch.12200. Epub 2014 Oct 6.

    PMID: 25287626BACKGROUND
  • Jones LM, Huggins TJ. The rationale and pilot study of a new paediatric dental patient request form to improve communication and outcomes of dental appointments. Child Care Health Dev. 2013 Nov;39(6):869-72. doi: 10.1111/j.1365-2214.2012.01416.x. Epub 2012 Jul 30.

    PMID: 22846104BACKGROUND

Study Officials

  • Viviane Colares, Professor

    University of Pernambuco

    STUDY CHAIR
  • Trícia Mayer, PhD student

    University of Pernambuco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Blindness will be possible to the psychologist, who will evaluates the patient's cooperation, and the statistician responsible for the data analysis.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student in Pediatric Dentistry, Principal Investigator

Study Record Dates

First Submitted

January 31, 2019

First Posted

April 9, 2019

Study Start

April 4, 2019

Primary Completion

November 28, 2019

Study Completion

November 28, 2019

Last Updated

February 19, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations