- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06928493
Are Pediatric Patients' Dental Anxiety Levels Affected by Covid -19 Clinical Conditions?
Assessment of Children's Dental Anxiety During the Pandemic: A Randomized Controlled Clinical Trial Utilizing Child Drawing: Hospital (CD:H) Picture Test
Changes in the dental office environment during the pandemic may affect the children's dental anxiety.
This double-blind, randomized, controlled clinical study aimed to assess children's dental anxiety focusing on changes in the dental office environment with the Child Drawing: Hospital (CD: H) picture test.The results showed that most children exhibited positive or very positive behavior and were not significantly affected by changes in the dental environment or clinical attire. The evaluations from the psychiatrist and dentist using CD: H were highly consistent.
Study Overview
Detailed Description
The study involved 120 children aged 5-7 years. All patients and their parents were informed about the purpose and method of the study before the study and signed informed consent forms.
Children's behaviors and attitudes before the dental exam were assessed using the Frankl behavioral scale. The children were then divided into two groups:The Pandemic Clinical Conditions (PCC) group, who were examined in an isolated dental office with special attire, and the Conventional Clinical Conditions (CCC) group, who were examined in a standard dental office with typical clinical attire. After the exam, the children were asked to draw a picture, which was then evaluated by a pediatric dentist and child psychiatrist using CD: H.
The results showed that most children exhibited positive or very positive behavior and were not significantly affected by changes in the dental environment or clinical attire. The evaluations from the psychiatrist and dentist using CD: H were highly consistent.
In conclusion, the changes in the dental office and clinical attire during the pandemic did not significantly impact children's anxiety levels.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara
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Çankaya, Ankara, Turkey
- Gazi University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Healthy children children between 5-7 years old no prior dentistry experience children willing to draw picture
Exclusion Criteria:
Children who had mental or physical disabilities children < 5 years old, previous dentist experience who refused to draw picture
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Pandemic Clinical Conditions (PCC)
The oral examination of PCC group was done in an isolated dental environment with white overalls, an FFP3 mask, and a visor.
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The pre-examination behaviors and attitudes of the children included in the study were measured by an independent dentist (Ş.Y.İ) using the Frankl Behavior Rating Scale (FS).
Following this, the children were randomly divided into two groups PCC and CCC .
The oral examination of PCC group was done in an isolated dental environment with white overalls, an FFP3 mask, and a visor.
The oral examination of CCC group was done in normal dental environment with a standard white coat and surgical mask.After that, patients were asked to draw themselves or the pediatric dentist who performed the examination.
A child psychiatrist (B.A.S.) and a pediatric dentist (R.D) with an internationally valid "Child Drawing Analysis" training certificate evaluated the children's drawings independently.
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Conventional Clinical Conditions (CCC)
The oral examination of CCC group was done in normal dental environment with a standard white coat and surgical mask.
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The pre-examination behaviors and attitudes of the children included in the study were measured by an independent dentist (Ş.Y.İ) using the Frankl Behavior Rating Scale (FS).
Following this, the children were randomly divided into two groups PCC and CCC .
The oral examination of PCC group was done in an isolated dental environment with white overalls, an FFP3 mask, and a visor.
The oral examination of CCC group was done in normal dental environment with a standard white coat and surgical mask.After that, patients were asked to draw themselves or the pediatric dentist who performed the examination.
A child psychiatrist (B.A.S.) and a pediatric dentist (R.D) with an internationally valid "Child Drawing Analysis" training certificate evaluated the children's drawings independently.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of Children's Dental Anxiety During the Pandemic: A Randomized Controlled Clinical Trial Utilizing Child Drawing: Hospital (CD:H) Picture Test
Time Frame: 3 months
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It is aimed to assess children's dental anxiety focusing on changes in the dental office environment with the Child Drawing: Hospital (CD: H) picture test.
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3 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Haluk Bodur, Prof. Dr, Gazi University Faculty of Dentistry
Publications and helpful links
General Publications
- Sharma A, Jain MB. Pediatric Dentistry during Coronavirus Disease-2019 Pandemic: A Paradigm Shift in Treatment Options. Int J Clin Pediatr Dent. 2020 Jul-Aug;13(4):412-415. doi: 10.5005/jp-journals-10005-1809.
- Assathiany R, Salinier C, Bechet S, Dolard C, Kochert F, Bocquet A, Levy C. Face Masks in Young Children During the COVID-19 Pandemic: Parents' and Pediatricians' Point of View. Front Pediatr. 2021 Jun 23;9:676718. doi: 10.3389/fped.2021.676718. eCollection 2021.
- Alsaleh MM, Sabbarini JM, Al-Batayneh OB, Khader YS. Changes in Behavior Management and Treatment Modalities in Pediatric Dentistry during COVID-19 Pandemic. Int J Clin Pediatr Dent. 2020;13(Suppl 1):S125-S131. doi: 10.5005/jp-journals-10005-1885.
- Clatworthy S, Simon K, Tiedeman ME. Child drawing: hospital--an instrument designed to measure the emotional status of hospitalized school-aged children. J Pediatr Nurs. 1999 Feb;14(1):2-9. doi: 10.1016/S0882-5963(99)80054-2.
- Azab MM. Influence of different personal protective equipment on children's anxiety in dental office: a randomized controlled trial. BMC Oral Health. 2022 Sep 22;22(1):421. doi: 10.1186/s12903-022-02442-5.
Helpful Links
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
Other Study ID Numbers
- GU.Ethics Committee 2022.07/1
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
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