NCT04762654

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 17, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

February 17, 2021

Last Update Submit

February 17, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

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.

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

children who presented for the first time to the Faculty of Dentistry in Rize

You may qualify if:

  • 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

You may not qualify if:

  • Children who had mental or physical disorders, cooperation problems or dental pain were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Recep Tayyip Erdogan University Training and Research Hospital

Rize, 53100, Turkey (Türkiye)

Location

Sema Aydinoğlu

Rize, Turkey (Türkiye)

Location

MeSH Terms

Conditions

BehaviorAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Ipek Arslan, Dr

    Recep Tayyip Erdogan University Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

February 17, 2021

First Posted

February 21, 2021

Study Start

April 15, 2020

Primary Completion

November 15, 2020

Study Completion

January 15, 2021

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations