Anxiety, DentalNCT06928493
Are Pediatric Patients' Dental Anxiety Levels Affected by Covid -19 Clinical Conditions?
An observational study of Anxiety, Dental, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Dental
- What is being tested?
- oral examination
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2024to 3 Nov 2024
- How long will I take part?
- 3 Months
- 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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- Healthy children children between 5-7 years old no prior dentistry experience children willing to draw picture
Who cannot join
- Children who had mental or physical disabilities children < 5 years old, previous dentist experience who refused to draw picture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety, Dental
- Being tested
- oral examination
- Keywords
- anxiety,child
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral examinationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: oral examination | |
| Conventional Clinical Conditions (CCC) | The oral examination of CCC group was done in normal dental environment with a standard white coat and surgical mask. Receives: Other: oral examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Children's Dental Anxiety During the Pandemic: A Randomized Controlled Clinical Trial Utilizing Child Drawing: Hospital (CD:H) Picture Test
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start2 Jan 2024
- Primary completion3 Feb 2024
- Study completion3 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anxiety, DentalStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 120 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alev Alaçam, Gazi University
- Investigators
- Haluk Bodur, Prof. Dr, Study chair, Gazi University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928493
- Sponsor's protocol ID
- GU.Ethics Committee 2022.07/1
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33149416Assathiany 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.
PubMed 34249814Alsaleh 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.
PubMed 34434029Clatworthy 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.
PubMed 10063243Azab 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.
PubMed 36138354
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Children's Dental Anxiety During the Pandemic: A Randomized Controlled Clinical Trial Utilizing Child Drawing: Hospital (CD:H) Picture Test
- ClinicalTrials.gov ID
- NCT06928493
- Acronym / sponsor ID
- GU.Ethics Committee 2022.07/1
- Conditions
- Anxiety, Dental
- Keywords
- anxiety,child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 3 Feb 2024 (actual)
- Study completion
- 3 Nov 2024 (actual)
- First posted
- 15 Apr 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pandemic Clinical Conditions (PCC) | – | Other: oral examinationThe oral examination of PCC group was done in an isolated dental environment with white overalls, an FFP3 mask, and a visor. |
| Conventional Clinical Conditions (CCC) | – | Other: oral examinationThe oral examination of CCC group was done in normal dental environment with a standard white coat and surgical mask. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- Healthy children children between 5-7 years old no prior dentistry experience children willing to draw picture
Key exclusion criteria (1 listed)
- Children who had mental or physical disabilities children < 5 years old, previous dentist experience who refused to draw picture
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 |
|---|---|---|
| oral examinationThe 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. | Other | Conventional Clinical Conditions (CCC), Pandemic Clinical Conditions (PCC) |
Primary outcome
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
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.
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 23 Apr 2025.
- Results publication: PubMed 33149416Sharma 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.
- Results publication: PubMed 34249814Assathiany 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.
- Results publication: PubMed 34434029Alsaleh 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.
- Results publication: PubMed 10063243Clatworthy 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.
- Results publication: PubMed 36138354Azab 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.
- References identifiedLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Haluk Bodur, Prof. Dr study chair
Gazi University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, Dental, run by Gazi University at 1 site 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 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06928493, which also lists 5 linked publications.
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 23 Apr 2025.