Parental Anxiety,Child BehaviorNCT05217225
The Association Between Parental Anxiety and Child Behavior.
An observational study of Parental Anxiety,Child Behavior, run by Cairo University.
Trial summary
Parents' dental anxiety is demonstrated as a significant indicator for children's dental anxiety and parents play a key role in children's anxiety and fear development. Studies have shown that parents who are fearful and anxious about dental treatments are associated with an increase in the occurrence of caries… Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Parental Anxiety,Child Behavior
- What is being tested?
- Simple restorative treatment
- Type of treatment
- Surgery or procedure
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- 24 Jun 2022to 24 Mar 2023
- 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 6 years
- All sexes
- Child
Study population: Children and parents attending to diagnosis clinics in Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Egypt.
Who may be able to join
- Children, age ranging from 4 to 6 years old, of both sexes, have simple Occlusal cavities attending the pediatric dental clinic.
- Parents of both genders
Who cannot join
- Children who do not have the cognition to respond to the anxiety test or are not authorized by parents and medically compromised children.
- Parents who could not respond to the research tools.
About this study
Official title: The Association Between Parental Anxiety and Child Behavior During Simple Restorative Treatment: A Cross-Sectional Study.
Parents' dental anxiety is demonstrated as a significant indicator for children's dental anxiety and parents play a key role in children's anxiety and fear development.
Studies have shown that parents who are fearful and anxious about dental treatments are associated with an increase in the occurrence of caries disease in their children, since they are more resistant to accompany their children to the dentist.
People with a high level of dental anxiety, both children and adults, can be difficult to treat, take longer, and have behavioral issues, all of which can lead to a stressful and unpleasant experience for both the patient and the dental practitioner
- Conditions
- Parental Anxiety,Child Behavior
- Being tested
- Simple restorative treatment
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple restorative treatmentProcedure or surgery
Simple Occlusal Cavity class I then followed by final restoration
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Parental anxiety
The Modified Dental Anxiety Scale Scores (5-25)
Measured: baseline
Secondary outcomes (2)
Prevalence of Child Anxiety
The Modified Venham Picture Test Scores (0- 8)
Measured: Baseline
Child behavior in dental care
Venham Behavior Rating Scale.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start24 Jun 2022 (estimated)
- Primary completion24 Oct 2022 (estimated)
- Study completion24 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parental Anxiety,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
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farah Magdy Ramsis Farah Guirgis, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217225
- Sponsor's protocol ID
- Child Behavior
- Status last verified
- Apr 2022
- First submitted
- 20 Jan 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Parental Anxiety and Child Behavior During Simple Restorative Treatment: A Cross-Sectional Study.
- ClinicalTrials.gov ID
- NCT05217225
- Acronym / sponsor ID
- Child Behavior
- Conditions
- Parental Anxiety,Child Behavior
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 24 Jun 2022 (estimated)
- Primary completion
- 24 Oct 2022 (estimated)
- Study completion
- 24 Mar 2023 (estimated)
- First posted
- 1 Feb 2022 (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.
Parents' dental anxiety is demonstrated as a significant indicator for children's dental anxiety and parents play a key role in children's anxiety and fear development.
Studies have shown that parents who are fearful and anxious about dental treatments are associated with an increase in the occurrence of caries disease in their children, since they are more resistant to accompany their children to the dentist.
People with a high level of dental anxiety, both children and adults, can be difficult to treat, take longer, and have behavioral issues, all of which can lead to a stressful and unpleasant experience for both the patient and the dental practitioner
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Age groups
- Child
- Study population
- Children and parents attending to diagnosis clinics in Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Egypt.
Key inclusion criteria (2 listed)
- Children, age ranging from 4 to 6 years old, of both sexes, have simple Occlusal cavities attending the pediatric dental clinic.
- Parents of both genders
Key exclusion criteria (2 listed)
- Children who do not have the cognition to respond to the anxiety test or are not authorized by parents and medically compromised children.
- Parents who could not respond to the research tools.
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 |
|---|---|---|
| Simple restorative treatmentSimple Occlusal Cavity class I then followed by final restoration | Procedure or surgery | – |
Primary outcome
Prevalence of Parental anxiety
Time frame: baseline
The Modified Dental Anxiety Scale Scores (5-25)
2 secondary outcomes
Prevalence of Child Anxiety
Time frame: Baseline
Child behavior in dental care
Time frame: During the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Parental Anxiety,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 2 inclusion and 2 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 6 Apr 2022. 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?
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?
Prevalence of Parental anxiety (time frame: baseline). 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 6 Apr 2022.