Dental AnxietyNCT03907514
Improving Adolescent-dentist Interaction Through Digital Technology
A study testing "FALE" Application in people with Dental Anxiety, run by University of Pernambuco at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- "FALE" Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Apr 2019to 28 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Brazilian adolescents literate in Portuguese
- Brazilian adolescents able to use smartphone
Who cannot join
- Adolescents with intellectual, sensory or physical disabilities
- Adolescents not capable to read and write/type
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Use of Digital Technology in Adolescent-dentist Interaction: Randomized Clinical Trial
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.
Read the 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%.
- Conditions
- Dental Anxiety
- Being tested
- "FALE" Application
- Keywords
- Technology Assessment, Health, Dental anxiety, Adolescent, Clinical Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"FALE" ApplicationBehavioural
"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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start4 Apr 2019
- Primary completion28 Nov 2019
- Study completion28 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pernambuco
- Sponsor type
- University, hospital or other
- Collaborators
- Coordination for the Improvement of Higher Education Personnel
- Responsible party
- Principal investigator, Trícia Murielly Andrade de Souza Mayer, University of Pernambuco
- Investigators
- Viviane Colares, Professor, Study chair, University of PernambucoTrícia Mayer, PhD student, Principal investigator, University of Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907514
- Sponsor's protocol ID
- 022019
- Status last verified
- Feb 2020
- First submitted
- 31 Jan 2019
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28857237Jones 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.
PubMed 25287626Jones 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.
PubMed 22846104
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Use of Digital Technology in Adolescent-dentist Interaction: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03907514
- Acronym / sponsor ID
- 022019
- Conditions
- Dental Anxiety
- Keywords
- Technology Assessment, Health, Dental anxiety, Adolescent, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- University of PernambucoUniversity, hospital or other
- Collaborators
- Coordination for the Improvement of Higher Education Personnel
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 28 Nov 2019 (actual)
- Study completion
- 28 Nov 2019 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (IG) | Experimental | Behavioral: "FALE" ApplicationThe 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. |
| 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. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Brazilian adolescents literate in Portuguese
- Brazilian adolescents able to use smartphone
Key exclusion criteria (2 listed)
- Adolescents with intellectual, sensory or physical disabilities
- Adolescents not capable to read and write/type
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "FALE" Application"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. | Behavioural | Intervention Group (IG) |
Primary outcome
Changes in adolescent patient's level of dental anxiety through the FALE application.
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Background: PubMed 28857237Yee 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.
- Background: PubMed 25287626Jones 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.
- Background: PubMed 22846104Jones 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viviane Colares, Professor study chair
University of Pernambuco
Trícia Mayer, PhD student principal investigator
University of Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "FALE" Application in people with Dental Anxiety, run by University of Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in adolescent patient's level of dental anxiety through the FALE application. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03907514, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020; AzTrials last refreshed its copy on 28 Oct 2026.