BehaviorNCT04762654
Turkish Version of Modified Child Dental Anxiety Scale
An observational study of Behavior and Child, Only, run by Recep Tayyip Erdogan University Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Background: The faces version of the Modified Child Dental Anxiety Scale (MCDASf) is less time consuming and an easy to understand tool for measuring dental anxiety. The aim of this study was to develop the Turkish version of MCDASf and to analyze its validity and reliability. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Child, Only, Anxiety, Dental
- What is being tested?
- Modified Child Dental Anxiety Scale (MCDASf)
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Apr 2020to 15 Jan 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children who presented for the first time to the Faculty of Dentistry in Rize
Who may be able to join
- aged between 6-12 years, intellectual sufficiency to complete the questionnaire, and voluntariness to take part in the study. Also, only children whose parents were willing to participate were included
Who cannot join
- Children who had mental or physical disorders, cooperation problems or dental pain were excluded from the study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Recep Tayyip Erdogan University Training and Research Hospital
Rize, 53100
Sema Aydinoğlu
Rize
About this study
Official title: Turkish Version of the Faces Version of the Modified Child Dental Anxiety Scale: Evaluation of Validity and Reliability
Background: The faces version of the Modified Child Dental Anxiety Scale (MCDASf) is less time consuming and an easy to understand tool for measuring dental anxiety. The aim of this study was to develop the Turkish version of MCDASf and to analyze its validity and reliability.
Read the detailed description
The internal consistency reliability was determined by calculating Cronbach's alpha (n=300). Intraclass correlation coefficients (ICCs) were calculated for test-retest reliability (n=67). Construct validity was determined by comparing with the Venham Picture Test (VPT). The factor structure was examined using exploratory factor analysis (EFA). Confirmatory factor analysis (CFA) was used for the dimensionality. The cut-off points of the Turkish version of MCDASf were plotted using a receiver operating characteristic (ROC) curve.
- Conditions
- Behavior, Child, Only, Anxiety, Dental
- Being tested
- Modified Child Dental Anxiety Scale (MCDASf)
- Medical subject headings
- Behavior, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Child Dental Anxiety Scale (MCDASf)Other
The MCDASf is self-reported dental anxiety measure effective among children aged 5-12 years.11 The scale has eight questions about 'going to the dentist generally,' 'having teeth examined,' 'teeth being scraped and polished,' 'injections in the gum,' 'fillings,' 'having a tooth taken out,' 'being put to sleep for treatment,' and 'having a mixture of gas and air that will help you feel comfortable for treatment but will not make you sleep.' The scores of each question ranged from 1 'relaxed' to 5 'very worried.' The scores are also represented by cartoon faces varied according to emotions and anxiety levels. The total scores can range from 8 to 40.
What is being measured
The primary outcome is the main question the study is designed to answer.
The Turkish version of MCDASf is a reliable scale that meets psychometric properties.
The reliability of the Turkish version of MCDASf was assessed using the Cronbach alpha coefficient and Intraclass correlation coefficients (ICCs). Cronbach alpha coefficient scores vary from 0 to 1. Values higher than 0.70 are considered acceptable, and values higher than 0.80 are considered good internal consistency reliability. ICC values lower than 0.40 indicate poor agreement, 0.41-0.60 moderate agreement, 0.61-0.80 good agreement, and values higher than 0.80 show excellent agreement.
Measured: for six months from the beginning of the study
The Turkish version of MCDASf is a valid scale that meets psychometric properties.
The validity of the Turkish version of MCDASf was assessed using The Venham Picture Test (VPT). The VPT includes eight cards that have two figures; one shows an anxious child, the other is not anxious. All cards are shown in order. For the selection of anxious and non-anxious figures, 1 and 0 points are recorded, respectively. The total scores can range from 1 to 8.
Measured: for six months from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start15 Apr 2020
- Primary completion15 Nov 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BehaviorStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sema Aydınoglu, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Ipek Arslan, Dr, Principal investigator, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762654
- Sponsor's protocol ID
- 985
- Status last verified
- Feb 2021
- First submitted
- 17 Feb 2021
- Last updated
- 21 Feb 2021
- 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 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Version of the Faces Version of the Modified Child Dental Anxiety Scale: Evaluation of Validity and Reliability
- ClinicalTrials.gov ID
- NCT04762654
- Acronym / sponsor ID
- 985
- Conditions
- Behavior, Child, Only, Anxiety, Dental
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 21 Feb 2021 (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.
Background: The faces version of the Modified Child Dental Anxiety Scale (MCDASf) is less time consuming and an easy to understand tool for measuring dental anxiety. The aim of this study was to develop the Turkish version of MCDASf and to analyze its validity and reliability.
Detailed description
The internal consistency reliability was determined by calculating Cronbach's alpha (n=300). Intraclass correlation coefficients (ICCs) were calculated for test-retest reliability (n=67). Construct validity was determined by comparing with the Venham Picture Test (VPT). The factor structure was examined using exploratory factor analysis (EFA). Confirmatory factor analysis (CFA) was used for the dimensionality. The cut-off points of the Turkish version of MCDASf were plotted using a receiver operating characteristic (ROC) curve.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children who presented for the first time to the Faculty of Dentistry in Rize
Key inclusion criteria (1 listed)
- aged between 6-12 years, intellectual sufficiency to complete the questionnaire, and voluntariness to take part in the study. Also, only children whose parents were willing to participate were included
Key exclusion criteria (1 listed)
- Children who had mental or physical disorders, cooperation problems or dental pain 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 |
|---|---|---|
| Modified Child Dental Anxiety Scale (MCDASf)The MCDASf is self-reported dental anxiety measure effective among children aged 5-12 years.11 The scale has eight questions about 'going to the dentist generally,' 'having teeth examined,' 'teeth being scraped and polished,' 'injections in the gum,' 'fillings,' 'having a tooth taken out,' 'being put to sleep for treatment,' and 'having a mixture of gas and air that will help you feel comfortable for treatment but will not make you sleep.' The scores of each question ranged from 1 'relaxed' to 5 'very worried.' The scores are also represented by cartoon faces varied according to emotions and anxiety levels. The total scores can range from 8 to 40. | Other | – |
Primary outcome
The Turkish version of MCDASf is a reliable scale that meets psychometric properties.
Time frame: for six months from the beginning of the study
The reliability of the Turkish version of MCDASf was assessed using the Cronbach alpha coefficient and Intraclass correlation coefficients (ICCs). Cronbach alpha coefficient scores vary from 0 to 1. Values higher than 0.70 are considered acceptable, and values higher than 0.80 are considered good internal consistency reliability. ICC values lower than 0.40 indicate poor agreement, 0.41-0.60 moderate agreement, 0.61-0.80 good agreement, and values higher than 0.80 show excellent agreement.
The Turkish version of MCDASf is a valid scale that meets psychometric properties.
Time frame: for six months from the beginning of the study
The validity of the Turkish version of MCDASf was assessed using The Venham Picture Test (VPT). The VPT includes eight cards that have two figures; one shows an anxious child, the other is not anxious. All cards are shown in order. For the selection of anxious and non-anxious figures, 1 and 0 points are recorded, respectively. The total scores can range from 1 to 8.
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 21 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Ipek Arslan, Dr principal investigator
Recep Tayyip Erdogan University Training and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behavior and Child, Only, run by Recep Tayyip Erdogan University Training and Research Hospital at 2 sites 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 1 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The Turkish version of MCDASf is a reliable scale that meets psychometric properties. (time frame: for six months from the beginning of the study). 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 21 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.