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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04762654
Other study ID # 985
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2020
Est. completion date January 15, 2021

Study information

Verified date February 2021
Source Recep Tayyip Erdogan University Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date January 15, 2021
Est. primary completion date November 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Children who had mental or physical disorders, cooperation problems or dental pain were excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
Turkey Recep Tayyip Erdogan University Training and Research Hospital Rize
Turkey Sema Aydinoglu Rize

Sponsors (1)

Lead Sponsor Collaborator
Recep Tayyip Erdogan University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. for six months from the beginning of the study
Primary 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. for six months from the beginning of the study
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