Dental AnxietyNCT04933578
Preferences About Personal Protective Equipment
An observational study of Dental Anxiety and Behavior, Child, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Personal protective equipment (PPE) gained importance during the Coronavirus Disease 2019 (COVID-19) pandemic, which is a global hot topic for all healthcare staff. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Behavior, Child, Preference, Patient
- What is being tested?
- Dental anxiety scales
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2021to 5 Apr 2021
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children who presented for the first time to the Faculty of Dentistry in Rize and their parents
Who may be able to join
- aged 6-12 years and their parents,
- intellectually sufficient to complete the questionnaire,
- with voluntariness to take part in the study
Who cannot join
- had mental or physical disorders, cooperation problems or dental pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Children and Parents' Preferences About the Appearance of Dentists With Respect to Personal Protective Equipment in Pediatric Dentistry
Personal protective equipment (PPE) gained importance during the Coronavirus Disease 2019 (COVID-19) pandemic, which is a global hot topic for all healthcare staff.
Read the detailed description
To assess children and parents preferences about dentists' appearance concerning their PPE and to determine the relationship between the preferences of the children and their parents.
A total of 250 children aged with 6-12 years and their parents were enrolled in the study. Standardised pictures with different sex, attire, eye protector, hair protector, mask and gloves were shown to children and their parents separately and asked to chose their preferences. Dental anxiety of children and their parents were determined with MCDASf and MDAS, respectively. Decayed-missing-filled teeth (DMFT) index was employed to the children.
- Conditions
- Dental Anxiety, Behavior, Child, Preference, Patient
- Being tested
- Dental anxiety scales
- Keywords
- Personal protective equipment, dental anxiety, parents, preferences, health care professionals
- Medical subject headings
- Child Behavior, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental anxiety scalesBehavioural
- The Faces Version of Modified Child Dental Anxiety Scale (MCDASf), which is a psychometric dental anxiety scale for children with eight questions, was used to determine the dental anxiety levels of the children. The scores of each question are represented by varying cartoon faces according to emotions ranging from 1 'relaxed' to 5 'very anxious'. The total scores range from 8 to 40. The scores were categorized as not anxious (>9), slightly anxious (9-16), fairly anxious (17-24), very anxious (25-32), and extremely anxious (33-40).
- the Modified Dental Anxiety Scale (MDAS) was administered to parents, differently from children. The MDAS has five questions. The scores of each question range from 1 'relaxed' to 5 'very anxious.' The total score ranges from 5 to 25.
| Study group | Role | What they receive |
|---|---|---|
| Children | 1. The Faces Version of Modified Child Dental Anxiety Scale (MCDASf), which is a psychometric dental anxiety scale for children with eight questions, was used to determine the dental anxiety levels of the children.
2. The children's preferences for the appearance of dentists were determined in the second part.
3. Routine dental examinations of children with a dental mirror and artificial light were completed by an experienced pediatric dentist according to the World Health Organization (WHO) guidelines and criteria. Receives: Behavioral: Dental anxiety scales | |
| Parents | 1. The questionnaire including demographic information (age, sex, and medical and dental history) was applied to the parents.
2. In the second section, the MDAS was administered to parents, differently from children.
3. The parents' preferences for the appearance of dentists were determined in the second part. Receives: Behavioral: Dental anxiety scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess children and parents preferences about dentists' appearance concerning their PPE and to determine the relationship between the preferences of the children and their parents according to dental anxiety levels.
Standardised pictures with different sex, attire, eye protector, hair protector, mask and gloves were shown to children and their parents separately and asked to chose their preferences. Dental anxiety of children and their parents were determined with MCDASf and MDAS, respectively.
Measured: for two months from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start15 Jan 2021
- Primary completion30 Mar 2021
- Study completion5 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sema Aydınoglu, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933578
- Sponsor's protocol ID
- 81
- Status last verified
- Jun 2021
- First submitted
- 18 Jun 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children and Parents' Preferences About the Appearance of Dentists With Respect to Personal Protective Equipment in Pediatric Dentistry
- ClinicalTrials.gov ID
- NCT04933578
- Acronym / sponsor ID
- 81
- Conditions
- Dental Anxiety, Behavior, Child, Preference, Patient
- Keywords
- Personal protective equipment, dental anxiety, parents, preferences, health care professionals
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 21 Jun 2021 (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.
Personal protective equipment (PPE) gained importance during the Coronavirus Disease 2019 (COVID-19) pandemic, which is a global hot topic for all healthcare staff.
Detailed description
To assess children and parents preferences about dentists' appearance concerning their PPE and to determine the relationship between the preferences of the children and their parents.
A total of 250 children aged with 6-12 years and their parents were enrolled in the study. Standardised pictures with different sex, attire, eye protector, hair protector, mask and gloves were shown to children and their parents separately and asked to chose their preferences. Dental anxiety of children and their parents were determined with MCDASf and MDAS, respectively. Decayed-missing-filled teeth (DMFT) index was employed to the children.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children | – | Behavioral: Dental anxiety scales1. The Faces Version of Modified Child Dental Anxiety Scale (MCDASf), which is a psychometric dental anxiety scale for children with eight questions, was used to determine the dental anxiety levels of the children. 2. The children's preferences for the appearance of dentists were determined in the second part. 3. Routine dental examinations of children with a dental mirror and artificial light were completed by an experienced pediatric dentist according to the World Health Organization (WHO) guidelines and criteria. |
| Parents | – | Behavioral: Dental anxiety scales1. The questionnaire including demographic information (age, sex, and medical and dental history) was applied to the parents. 2. In the second section, the MDAS was administered to parents, differently from children. 3. The parents' preferences for the appearance of dentists were determined in the second part. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children who presented for the first time to the Faculty of Dentistry in Rize and their parents
Key inclusion criteria (3 listed)
- aged 6-12 years and their parents,
- intellectually sufficient to complete the questionnaire,
- with voluntariness to take part in the study
Key exclusion criteria (1 listed)
- had mental or physical disorders, cooperation problems or dental pain
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 |
|---|---|---|
| Dental anxiety scales* The Faces Version of Modified Child Dental Anxiety Scale (MCDASf), which is a psychometric dental anxiety scale for children with eight questions, was used to determine the dental anxiety levels of the children. The scores of each question are represented by varying cartoon faces according to emotions ranging from 1 'relaxed' to 5 'very anxious'. The total scores range from 8 to 40. The scores were categorized as not anxious (>9), slightly anxious (9-16), fairly anxious (17-24), very anxious (25-32), and extremely anxious (33-40). * the Modified Dental Anxiety Scale (MDAS) was administered to parents, differently from children. The MDAS has five questions. The scores of each question range from 1 'relaxed' to 5 'very anxious.' The total score ranges from 5 to 25. | Behavioural | Children, Parents |
Primary outcome
To assess children and parents preferences about dentists' appearance concerning their PPE and to determine the relationship between the preferences of the children and their parents according to dental anxiety levels.
Time frame: for two months from the beginning of the study
Standardised pictures with different sex, attire, eye protector, hair protector, mask and gloves were shown to children and their parents separately and asked to chose their preferences. Dental anxiety of children and their parents were determined with MCDASf and MDAS, respectively.
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 21 Jun 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dental Anxiety and Behavior, Child, run by Recep Tayyip Erdogan University Training and Research Hospital 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 3 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 21 Jun 2021. 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?
To assess children and parents preferences about dentists' appearance concerning their PPE and to determine the relationship between the preferences of the children and their parents according to dental anxiety levels. (time frame: for two months from the beginning of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2021.