Clinical trial NCT06928493: Are Pediatric Patients' Dental Anxiety Levels Affected by Covid -19 Clinical Conditions?
Official title: Assessment of Children's Dental Anxiety During the Pandemic: A Randomized Controlled Clinical Trial Utilizing Child Drawing: Hospital (CD:H) Picture Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety, Dental
Keywords: anxiety,child
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 120
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 120 healthy patient aged 5-7 years who had no prior dentistry experience and whose parents agree to participate in the study,children willing to draw were included the study

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of Children's Dental Anxiety During the Pandemic: A Randomized Controlled Clinical Trial Utilizing Child Drawing: Hospital (CD:H) Picture Test
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Çankaya
country: Turkey
facility: Gazi University
state: Ankara
Study officials:
affiliation: Gazi University Faculty of Dentistry
name: Haluk Bodur, Prof. Dr
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.