Clinical trial NCT03907514: Improving Adolescent-dentist Interaction Through Digital Technology
Official title: Impact of the Use of Digital Technology in Adolescent-dentist Interaction: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Keywords: Technology Assessment, Health
Dental anxiety
Adolescent
Clinical Trial
Lead sponsor: University of Pernambuco
Sponsor class: OTHER
Collaborators: name: Coordination for the Improvement of Higher Education Personnel
First posted: 2019-04-09
Enrollment: 184
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: The target population consists of patients between 10 and 19 years old, attending the Adolescent Clinic in the Dental School of the Federal University of Pernambuco (UFPE), campus of Recife. The sample will consist of 184 adolescents, 92 in each group (intervention and control). Randomization will be stratified according to sex, age and presence or absence of dental anxiety. In the waiting room, before the dental appointment, the adolescents in the intervention group (IG) will use the FALE application to answer the questionnaire and assess the level of anxiety. Those in the control group (CG) will only record their level of anxiety. The undergraduates responsible for attending the IG participants will receive, prior to dental care, a report of the answers given by the adolescents through the application. During the dental consultation, a psychologist, who will be observing the care, will evaluate the adolescents behavior, considering cooperation. After the appointment, the adolescent will evaluate how much he/she felt benefited by the use of the app; how he evaluates the communication between him/her and the dentist; if he/she thinks that the app contributed with this communication; his/her satisfaction with dental treatment; and his/her satisfaction with the undergraduate attendance. The undergraduate will also evaluate his/her level of satisfaction with the application's use; how he/she evaluates the communication between him/her and the adolescent patient; how much the application has helped with this communication; and the degree of patient's cooperation during the dental consultation. Descriptive and inferential statistical analysis will be performed using appropriate tests through the Statistical Package for Social Sciences software version 21 and significance level of 5%.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Changes in adolescent patient's level of dental anxiety through the FALE application.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Federal University of Pernambuco
state: Pernambuco
Study officials:
affiliation: University of Pernambuco
name: Viviane Colares, Professor
role: STUDY_CHAIR
affiliation: University of Pernambuco
name: Trícia Mayer, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.