Psychological DisordersNCT03909243
Assessment of Child Psychological Attributes for Prediction of Child Behavior at First Dental Visit
An observational study of Psychological Disorders, run by Cairo University.
Trial summary
One of the most prevalent chronic diseases worldwide is mental disorder, including social, emotional, and behavioral problems, and it is the fifth main cause of global disability . Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Disorders
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Jul 2020
- 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Out patients of Pediatric Dentistry and Dental Public Health Department at Faculty of Dentistry, Cairo University, Egypt who are having a dental problem and coming for their first dental visit.
Who may be able to join
- Children: school aged children (4 to 7) years old
- Teeth: carious teeth requiring a simple dental treatment (cavity preparation with restoration)
Who cannot join
- Children:
- Medically compromised children.
- Children with previous dental history.
- Refusal of participation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Child Psychological Attributes Using Strength and Difficulties Questionnaire for Prediction of Child Behavior at First Dental Visit Through: A Cross Sectional Study
One of the most prevalent chronic diseases worldwide is mental disorder, including social, emotional, and behavioral problems, and it is the fifth main cause of global disability . In Egypt, it is estimated that 20.6% of children aged from 6-12 years had behavioral problems
Behavioral and emotional problems may affect deeply child's quality of life, such as impairment of school life (high absence), They may cause nutritional imbalance and even suicidal thoughts. Therefore, both the dentist and the family should be adequately prepared to deal with those children who come seeking dental treatment.
Read more
Recently, studies proved the association between the psychological characteristics and the behavior of children in dental setting. There was a study that showed that there is a relation between psychological functioning of the child, dental anxiety and his/her behaviour during dental appointment. Furthermore, it was found that there is a correlation between the temperamental difficulties or emotional problems of the child and the non-cooperative behavior during the process of injection of the local anesethia.
These studies ensures the importance of understanding the effect of mental disorders on the behavior of children during dental treatment, as it would help the professionals to properly plan the clinic appointments without any delay or cancellation of the appointment and allows him to render effective and efficient dental treatment.
Read the detailed description
this study aims to acknowledge the different psychological attributes among children seeking dental treatment at young age and to assess the association between child psychological attributes and his/her behavior in dental clinic.
- Conditions
- Psychological Disorders
- Keywords
- psychological attributes, child mental disorders, strength and difficulties questionnaire, child behavior
- Medical subject headings
- Mental Disorders, Neurodevelopmental Disorders, Child Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Child psychological attributes
Total difficulty score using strengths and difficulties questionnaire (0-40)
0-13 normal
14-16 border line
17-40 abnormal
Measured: 6 months
Secondary outcomes (1)
Actual child behavior during the dental treatment.
Rating (0-4) using Fankl scale
Rating 1 (--) definitely negative Refusal of treatment, forceful crying, fearfulness or any other overt evidence of extreme negativism.
Rating 2 (-) negative Reluctance to accept treatment, uncooperativeness, some evidence of negative attitude but not pronounced.
Rating 3 (+) positive Acceptance of treatment, cautious behaviour at times willingness to comly with the dentist, at times with reservation, but patient follows the dentist's directions cooperatively.
Rating 4 (++) definitely positive Good rapport with the dentist, interest in the dental procedure, laughing and enjoying the situation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study startAug 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DisordersStudies 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
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Moussa Anwar, Cairo University
- Investigators
- Sandra M Anwar, BSc, Principal investigator, Resident at pediatric Dentistry and Dental Public Health DepartmentSara A Mahmoud, phD, Study director, Associate professor at pediatric Dentistry and Dental Public Health Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909243
- Sponsor's protocol ID
- 14422017495365
- Status last verified
- Apr 2019
- First submitted
- 5 Apr 2019
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Child Psychological Attributes Using Strength and Difficulties Questionnaire for Prediction of Child Behavior at First Dental Visit Through: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT03909243
- Acronym / sponsor ID
- 14422017495365
- Conditions
- Psychological Disorders
- Keywords
- psychological attributes, child mental disorders, strength and difficulties questionnaire, child behavior
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 9 Apr 2019 (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.
One of the most prevalent chronic diseases worldwide is mental disorder, including social, emotional, and behavioral problems, and it is the fifth main cause of global disability . In Egypt, it is estimated that 20.6% of children aged from 6-12 years had behavioral problems
Behavioral and emotional problems may affect deeply child's quality of life, such as impairment of school life (high absence), They may cause nutritional imbalance and even suicidal thoughts. Therefore, both the dentist and the family should be adequately prepared to deal with those children who come seeking dental treatment.
Recently, studies proved the association between the psychological characteristics and the behavior of children in dental setting. There was a study that showed that there is a relation between psychological functioning of the child, dental anxiety and his/her behaviour during dental appointment. Furthermore, it was found that there is a correlation between the temperamental difficulties or emotional problems of the child and the non-cooperative behavior during the process of injection of the local anesethia.
These studies ensures the importance of understanding the effect of mental disorders on the behavior of children during dental treatment, as it would help the professionals to properly plan the clinic appointments without any delay or cancellation of the appointment and allows him to render effective and efficient dental treatment.
Detailed description
this study aims to acknowledge the different psychological attributes among children seeking dental treatment at young age and to assess the association between child psychological attributes and his/her behavior in dental clinic.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Out patients of Pediatric Dentistry and Dental Public Health Department at Faculty of Dentistry, Cairo University, Egypt who are having a dental problem and coming for their first dental visit.
Key inclusion criteria (2 listed)
- Children: school aged children (4 to 7) years old
- Teeth: carious teeth requiring a simple dental treatment (cavity preparation with restoration)
Key exclusion criteria (4 listed)
- Children:
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
Child psychological attributes
Time frame: 6 months
Total difficulty score using strengths and difficulties questionnaire (0-40) 0-13 normal 14-16 border line 17-40 abnormal
1 secondary outcome
Actual child behavior during the dental treatment.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
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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.
Sandra M Anwar, BSc principal investigator
Resident at pediatric Dentistry and Dental Public Health Department
Sara A Mahmoud, phD study director
Associate professor at pediatric Dentistry and Dental Public Health Department
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Disorders, 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 2 inclusion and 4 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 9 Apr 2019. 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 Sandra M Anwar, BSc (01224774226, Sandra_jacob@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child psychological attributes (time frame: 6 months). 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 9 Apr 2019.