Tooth DiseasesNCT06525090
Turkish Version of Child-Friendly Oral Health Questionnaire
An observational study of Tooth Diseases and Oral Disease, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
Oral problems are a common occurrence among school-age children. In order to develop effective oral health interventions and services, it is essential to determine children's oral health behaviours using an internationally accepted standardised instrument that is child-friendly. Read more about this study
- Who is it for?
- Ages 9 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Diseases, Oral Disease
- How many people
- 298 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 31 Dec 2021
- Phase
- Observational
- 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 9 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The population of the study consisted of 5077 primary school students studying in 12 primary schools in the center of Fethiye in the 2020-2021 academic year. The study population comprised students in the third class of all primary schools in the centre of Fethiye. It is well-established that the sample size in validity and reliability studies should be at least 3-10 times the number of items.[11] To ensure the homogeneous distribution of students, the stratified random sampling method was used. In the sample determined by the stratified random sampling method, the number of students per school was determined and the students in the schools were stratified according to their classes, and data were collected from a total of 298 students
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Psychometric Properties of the Turkish Child-Friendly Oral Health Questionnaire
Oral problems are a common occurrence among school-age children. In order to develop effective oral health interventions and services, it is essential to determine children's oral health behaviours using an internationally accepted standardised instrument that is child-friendly. However, no instrument currently exists to measure oral health according to the Theory of Planned Behaviour (TPB) in Turkish school-aged children. The aim of this study was to investigate the psychometric properties of the Oral Health Questionnaire, which includes the components of the theory of planned behavior such as attitude toward children's oral health, subjective norm, perceived behavioral control, and self-efficacy, for the Turkish population
Read the 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)
- Conditions
- Tooth Diseases, Oral Disease
- Being tested
- no intervention-child-administered questionnaires
- Keywords
- validity, reliability, oral health
- Medical subject headings
- Tooth Diseases, Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention-child-administered questionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 298 school children aged 9-10 years | 298 school children aged 9-10 years. Receives: Other: no intervention-child-administered questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
reliability
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.
Measured: 2 months
validity
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 May 2021
- Primary completion1 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiseasesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Collaborators
- recep kara, özgül Cartı Dörterler, gülay manav
- Responsible party
- Principal investigator, Gonca Karayagiz Muslu, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525090
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Psychometric Properties of the Turkish Child-Friendly Oral Health Questionnaire
- ClinicalTrials.gov ID
- NCT06525090
- Conditions
- Tooth Diseases, Oral Disease
- Keywords
- validity, reliability, oral health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Collaborators
- recep kara, özgül Cartı Dörterler, gülay manav
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 29 Jul 2024 (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.
Oral problems are a common occurrence among school-age children. In order to develop effective oral health interventions and services, it is essential to determine children's oral health behaviours using an internationally accepted standardised instrument that is child-friendly. However, no instrument currently exists to measure oral health according to the Theory of Planned Behaviour (TPB) in Turkish school-aged children. The aim of this study was to investigate the psychometric properties of the Oral Health Questionnaire, which includes the components of the theory of planned behavior such as attitude toward children's oral health, subjective norm, perceived behavioral control, and self-efficacy, for the Turkish population
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 298 school children aged 9-10 years | – | Other: no intervention-child-administered questionnaires298 school children aged 9-10 years. |
Who may qualify
- Ages
- 9 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The population of the study consisted of 5077 primary school students studying in 12 primary schools in the center of Fethiye in the 2020-2021 academic year. The study population comprised students in the third class of all primary schools in the centre of Fethiye. It is well-established that the sample size in validity and reliability studies should be at least 3-10 times the number of items.[11] To ensure the homogeneous distribution of students, the stratified random sampling method was used. In the sample determined by the stratified random sampling method, the number of students per school was determined and the students in the schools were stratified according to their classes, and data were collected from a total of 298 students
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| no intervention-child-administered questionnairesThe 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. | Other | 298 school children aged 9-10 years |
Primary outcome
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.
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.
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 29 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Tooth Diseases
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingPhase 2
Melatonin in Posterior Mandible Extraction Socket
Bone Loss
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Diseases and Oral Disease, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
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 4 inclusion and 1 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 29 Jul 2024. 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 Turkey (Türkiye). 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?
reliability (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2024.