Child BehaviorNCT04307810
Parent Predicting of Their Child Behavior During Their First Dental Examination
An observational study of Child Behavior, run by Cairo University.
Trial summary
The aim of this study is to assess the parental expectation for their child behavior in a group of children with primary dentition during their first dental examination Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Child Behavior
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2020to 15 Jun 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: children with primary dentition
Who may be able to join
- Child with Primary dentition
- First dental visit.
- Parents of children who agree to fill the questionnaire.
Who cannot join
- Child with dental emergency
- Child with psychological problem
- Child with chronic illness
Trial locations and contacts
No sites are listed yet.
Fatma Korany Ismail fatmadent@hotmail.com, Phd contact
About this study
Official title: Parental Expectation for Their Child Behavior in a Group of Children With Primary Dentition During Their First Dental Examination
The aim of this study is to assess the parental expectation for their child behavior in a group of children with primary dentition during their first dental examination
Read the detailed description
Assessment of children based on their behavior is one of the most important skills for a pediatric dentist. The major aspect of child management in the dental care is managing dental anxiety and fear as it is considered to be the main barrier for successful completion of dental treatment.
Dental anxiety is a common problem which develops mostly in childhood and adolescence. It can have major implications for the child, dental team, and dental services. Providing treatment for the child with dental anxiety can be time-consuming, costly, and demanding for the clinician.
Previous studies have shown that a majority of children with dental anxiety present behavior management problems (BMP) in dental treatment situations. Evaluating a child's level of anxiety before pediatric treatment is the key, since this anxiety is closely related to their behavior during dental visits. Therefore, predicting the behavior is a basic requirement to reduce child's negative attitude during treatment.
Many behavior rating scales are available to assess and evaluate the behavior of a child on each dental visit. Frankl et al classified child's behavior into four groups according to the child's attitude and cooperation or lack of cooperation during dental treatment. This classification is known as Frankl behavior rating scale, which is one of the most reliable tools developed for behavior rating of children in dental sittings.
- Conditions
- Child Behavior
- Medical subject headings
- Child Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental expectation for their child behavior
Each parent or caregiver will be asked to fill a questionnaire which includes multiple behavior and actions exhibited by the parents and according to their answers will determine the positive behavior of child
Measured: 1 year
Secondary outcomes (1)
Child behavior
The behavior of the child during his first dental visit will be monitored and videotaped then analyzed in relation to the answers and it well be Measured by using frankl scale.:
- _ _ Definitely negative. Refusal of treatment, forceful crying, fearfulness, or any other overt evidence of extreme negativism.
- _ Negative. Reluctance to accept treatment, uncooperative, some evidence of negative attitude but not pronounced (sullen, withdrawn).
- + Positive. Acceptance of treatment; cautious behavior at times; willingness to comply with the dentist, at times with reservation, but patient follows the dentist's directions cooperatively.
- ++ Definitely positive. Good rapport with the dentist, interest in the dental procedures, laughter and enjoyment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start15 Apr 2020 (estimated)
- Primary completion15 Apr 2021 (estimated)
- Study completion15 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Alsayed Mohamed Saleh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307810
- Sponsor's protocol ID
- child behavior expectation
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 13 Mar 2020
- 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 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Expectation for Their Child Behavior in a Group of Children With Primary Dentition During Their First Dental Examination
- ClinicalTrials.gov ID
- NCT04307810
- Acronym / sponsor ID
- child behavior expectation
- Conditions
- Child Behavior
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Apr 2020 (estimated)
- Primary completion
- 15 Apr 2021 (estimated)
- Study completion
- 15 Jun 2021 (estimated)
- First posted
- 13 Mar 2020 (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.
The aim of this study is to assess the parental expectation for their child behavior in a group of children with primary dentition during their first dental examination
Detailed description
Assessment of children based on their behavior is one of the most important skills for a pediatric dentist. The major aspect of child management in the dental care is managing dental anxiety and fear as it is considered to be the main barrier for successful completion of dental treatment.
Dental anxiety is a common problem which develops mostly in childhood and adolescence. It can have major implications for the child, dental team, and dental services. Providing treatment for the child with dental anxiety can be time-consuming, costly, and demanding for the clinician.
Previous studies have shown that a majority of children with dental anxiety present behavior management problems (BMP) in dental treatment situations. Evaluating a child's level of anxiety before pediatric treatment is the key, since this anxiety is closely related to their behavior during dental visits. Therefore, predicting the behavior is a basic requirement to reduce child's negative attitude during treatment.
Many behavior rating scales are available to assess and evaluate the behavior of a child on each dental visit. Frankl et al classified child's behavior into four groups according to the child's attitude and cooperation or lack of cooperation during dental treatment. This classification is known as Frankl behavior rating scale, which is one of the most reliable tools developed for behavior rating of children in dental sittings.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children with primary dentition
Key inclusion criteria (3 listed)
- Child with Primary dentition
- First dental visit.
- Parents of children who agree to fill the questionnaire.
Key exclusion criteria (3 listed)
- Child with dental emergency
- Child with psychological problem
- Child with chronic illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Parental expectation for their child behavior
Time frame: 1 year
Each parent or caregiver will be asked to fill a questionnaire which includes multiple behavior and actions exhibited by the parents and according to their answers will determine the positive behavior of child
1 secondary outcome
Child behavior
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
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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.
Fatma Korany Ismail fatmadent@hotmail.com, Phd contact
Questions about this trial
What is this clinical trial studying?
An observational study of Child Behavior, run by Cairo University.
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 3 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: status not confirmed, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heba Alsayed, Master (+201006187688, dr.heba9090@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental expectation for their child behavior (time frame: 1 year). 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 13 Mar 2020.