- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06525090
Turkish Version of Child-Friendly Oral Health Questionnaire
Investigation of the Psychometric Properties of the Turkish Child-Friendly Oral Health Questionnaire
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Oral Health Questionnaire was used as the data collection tool in the study. It was developed by Davison et al. (2017) as a child-friendly scale consisting of 57 questions in a 5-point Likert type based on the TPB [6]. The scale consists of three parts. The first part consists of questions to obtain sociodemographic information (items 1-9), and the second part consists of questions to determine the behavioral characteristics of the individual toward tooth brushing. Tooth brushing behaviors are evaluated based on the individual's statements. The last part of the scale consists of questions to determine direct and indirect measures of beliefs based on the theory of planned behavior. We used the Pictorial rating Likert scales as original.
The translation is the first step in the adaptation process. After the scale was translated into Turkish, a common Turkish version was developed by the researchers through group work. The Turkish version of the scale was translated into English by a different linguist who is an expert in both Turkish and English. To determine the content validity of the scale whose language validity was completed, it was submitted to the opinions of 10 faculty members, including pediatric nursing, public health nursing, and pedodontics experts. After receiving expert opinions, it is recommended to administer the scale to a group of approximately 20-30 individuals who have similar characteristics with the study subjects for pilot study. For the language validity of the scale, the translation-back translation technique was used, and for content validity, I-CVI and S-CVI were used Davis technique. According to Davis technique, each item of the scale was evaluated by ten faculty members who are experts in the field by choosing one of the four rating options from 1 (not relevant) to 4 (highly relevant). Item Content Validity Index (I-CVI) for each item was obtained by dividing the number of experts who chose option (3) or (4) when evaluating each item and dividing by the total number of experts. The intraclass correlation coefficient was used to evaluate the expert opinions for the content validity of the scale. Regarding reliability, the Cronbach alpha reliability coefficient was used to evaluate the internal consistency of the scale and its sub-dimensions, and Pearson product-moment correlation was used to compare item-total score correlations. Correlation and regression analysis were conducted for predictive validity. While the sample size was analyzed with Kaiser-Meyer-Olkin, its suitability for factor analysis was tested with Bartlett's Test of Sphericity, factor analysis, and principal component analysis. CFA was used to determine whether the items and subscales explained the original scale structure. CFA were performed on the same sample, the general sample was randomly split. The model verification of the comparative fit index (CFI) was conducted based on the chi-square test, degree of freedom, root mean square error of approximation (RMSEA), goodness of fit index (GFI), and normal fit index (NFI)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Fethiye, Turkey
- 12 Primary Schools
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Third-class students of central primary schools affiliated with the Directorate of National Education in Fethiye,
- Those without any communication barrier
- Those with reading and writing skills who can answer questionnaires
- Families who agreed to participate in the study and students who volunteered
Exclusion Criteria:
- Students and the parents who did not agree to participate in the study or who wanted to leave the study after it started were excluded from the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
298 school children aged 9-10 years
298 school children aged 9-10 years.
|
The implementation of the research was started after getting approval from Mugla Sıtkı Kocman University Health Sciences Ethics Committee and TR Ministry of National Education Research, Competition and Social Activity.
The purpose of the study was explained by the researchers to the administrators of the schools where the study was conducted and planning was made with the school administration.
The data were collected in 15-20 minutes from the students who agreed to participate in the study during the course hours deemed appropriate by the administration.
The purpose of the study and how to fill in the measurement tools was explained to the students, and it was stated that the research data would be kept confidential and used only by the researcher.
The self-administered questionnaires were filled out on the paper.
Verbal consent was obtained from the students participating in the study and written informed consent was obtained from their parents.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
reliability
Time Frame: 2 months
|
To measure stability of the test over time by Turkish Version of Child-Friendly Oral Health Questionnaire.
Turkish Version of Child-Friendly Oral Health Questionnaireis filled with two week interval.
|
2 months
|
|
validity
Time Frame: 6 months
|
To test in order to establish the correlation among the proposed instrument and instruments that had already been translated and validated.
factor analysis was done.
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tooth Diseases
-
Aula Dental AvanzadaRecruitingTooth Extrusion | Tooth Fracture | Tooth Avulsion | Tooth ExtrudedSpain
-
OrganTech, Inc.RecruitingDental Caries | Tooth Extraction | Tooth Fractures | Tooth DislocationJapan
-
HALEONCompletedTooth ErosionUnited States
-
Colgate PalmoliveCompleted
-
Shanghai Ninth People's Hospital Affiliated to...RecruitingTooth Decay | Tooth FractureChina
-
Sun Yat-sen UniversityShenzhen Yunding Information Technology Co., Ltd.Completed
-
University of MichiganDentsply Sirona Inc.TerminatedFractured Tooth | Decayed Tooth | Unsatisfactory Restoration of ToothUnited States
-
University of MichiganIvoclar Vivadent AGCompletedFractured Tooth | Decayed Tooth | Unsatisfactory Restoration of ToothUnited States
-
University of MichiganDentsply Sirona Implants and ConsumablesActive, not recruitingFractured Tooth | Decayed Tooth | Unsatisfactory Restoration of ToothUnited States
-
Colgate PalmoliveCompleted
Clinical Trials on no intervention-child-administered questionnaires
-
Azienda Ospedaliero-Universitaria CareggiRecruitingAir Pollution | Emergency Service, Hospital | WeatherItaly
-
University of SouthamptonUniversity Hospital Southampton NHS Foundation Trust; National Institute for... and other collaboratorsRecruitingHuntington DiseaseUnited Kingdom
-
Oregon Health and Science UniversityMassachusetts General Hospital; National Eye Institute (NEI); University of Illinois... and other collaboratorsRecruiting
-
Anumana, Inc.CompletedCardiovascular Diseases | Atrial Fibrillation | Left Atrial Appendage ClosureUnited States
-
Exactis InnovationKnight TherapeuticsCompleted
-
Azienda Sanitaria Locale CN2 Alba-BraRecruitingBreast Cancer Screening | Breast Cancer Screening and DiagnosisItaly
-
Lund UniversityThe Swedish Research Council; Swedish Council for Working Life and Social Research and other collaboratorsActive, not recruiting
-
National Opinion Research CenterChapin Hall at the University of Chicago; Office of Planning, Research & Evaluation and other collaboratorsActive, not recruiting
-
NHS GrampianCompleted
-
Pirogov Russian National Research Medical UniversityCompletedChronic Venous InsufficiencyRussian Federation