Behavior, ChildNCT05026515
The Influence of Parental Behavior on the Course of the Pediatric Dentistry Session
An observational study of Behavior, Child and Parents, run by Université Libre de Bruxelles at 1 site in Belgium.
Trial summary
The aim of the experiment is to analyze the impact of the behavior of the accompanying parent on the behavior of the child during a first dental session according to the age group. Read more about this study
- Who is it for?
- Ages 1 year to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Child, Parents, Dental Anxiety
- What is being tested?
- Parents
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Dec 2020to 2 Mar 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 1 year to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 60 patients presenting for the first time to the pediatric dentistry consultation at the CHU Saint-Pierre - César de Paepe site were selected for this study between. 3 groups of 20 children, respectively aged 4 and under, 5 to 6 years old and over 7 years old, were formed.67 children participated in this study. They were divided into 3 groups according to their age (4 years and under, 5 to 6 years and 7 years and over). During the search, 7 patients were excluded: due to the image rights not granted. The data were collected and analyzed by 2 observers. Then a randomization took place thus creating a sample of 15 children divided into 3 same groups. The data were collected and analyzed by 20 practitioner observers
Who may be able to join
- be in the correct age group and agree to participate in the study
Who cannot join
- not be in the right age group, refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Parental Behavior on the Course of the Pediatric Dentistry : a Prospective Study
The aim of the experiment is to analyze the impact of the behavior of the accompanying parent on the behavior of the child during a first dental session according to the age group.
Read the detailed description
I will receive the children for consultation at the CHU Saint Pierre - César de Paepe site, to assess the impact of parents' behavior on the child.
First, I will make a first contact with the child in the waiting room using the CORAH scale (self-assessment based on diagrams) which will allow him to assess his temperament in the face of dental care. . Then, I will have the parents / caregiver sign informed consent and authorization to film.
Once the child enters the practice, the video recording will be initiated: the installation on the seat, the confidence building and the care provided will be filmed.
These videos will then be analyzed by several practitioners from different categories (experts in pedodontics, general dentists, dental students, etc.) using the Venham hetero-assessment scale modified for the behavior of the child and of a scale of parental cooperation. These practitioners will be selected via the ADUB (association of dentists of Université Libre de Bruxelles) and some of them could be external to the hospital.
Following this study, the results obtained will be described and statistically analyzed.
- Conditions
- Behavior, Child, Parents, Dental Anxiety
- Being tested
- Parents
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParentsBehavioural
To observe the influence of the parents/caregivers behavior on their child during dental treatment
| Study group | Role | What they receive |
|---|---|---|
| 4 years and under | Children coming at dental appointment, aged 4 years and under Receives: Behavioral: Parents | |
| 5 to 6 years | Children coming at dental appointment, aged 5 to 6 years Receives: Behavioral: Parents | |
| 7 years and over | Children coming at dental appointment, aged 7 years and over Receives: Behavioral: Parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent behavior/Child Behavior
By hetero-evaluation scale, 20 dentists will estimate the behavior of parents and children. The measurements via the observation of filmed sessions were carried out thanks to two views.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start13 Dec 2020
- Primary completion13 Dec 2020
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, ChildStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tania Vanhée, Université Libre de Bruxelles
- Investigators
- Tania Vanhee, DDS, Principal investigator, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026515
- Sponsor's protocol ID
- O.M. 007
- Status last verified
- Aug 2021
- First submitted
- 24 Apr 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Parental Behavior on the Course of the Pediatric Dentistry : a Prospective Study
- ClinicalTrials.gov ID
- NCT05026515
- Acronym / sponsor ID
- O.M. 007
- Conditions
- Behavior, Child, Parents, Dental Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Study start
- 13 Dec 2020 (actual)
- Primary completion
- 13 Dec 2020 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 30 Aug 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.
The aim of the experiment is to analyze the impact of the behavior of the accompanying parent on the behavior of the child during a first dental session according to the age group.
Detailed description
I will receive the children for consultation at the CHU Saint Pierre - César de Paepe site, to assess the impact of parents' behavior on the child.
First, I will make a first contact with the child in the waiting room using the CORAH scale (self-assessment based on diagrams) which will allow him to assess his temperament in the face of dental care. . Then, I will have the parents / caregiver sign informed consent and authorization to film.
Once the child enters the practice, the video recording will be initiated: the installation on the seat, the confidence building and the care provided will be filmed.
These videos will then be analyzed by several practitioners from different categories (experts in pedodontics, general dentists, dental students, etc.) using the Venham hetero-assessment scale modified for the behavior of the child and of a scale of parental cooperation. These practitioners will be selected via the ADUB (association of dentists of Université Libre de Bruxelles) and some of them could be external to the hospital.
Following this study, the results obtained will be described and statistically analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4 years and under | – | Behavioral: ParentsChildren coming at dental appointment, aged 4 years and under |
| 5 to 6 years | – | Behavioral: ParentsChildren coming at dental appointment, aged 5 to 6 years |
| 7 years and over | – | Behavioral: ParentsChildren coming at dental appointment, aged 7 years and over |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 60 patients presenting for the first time to the pediatric dentistry consultation at the CHU Saint-Pierre - César de Paepe site were selected for this study between. 3 groups of 20 children, respectively aged 4 and under, 5 to 6 years old and over 7 years old, were formed.67 children participated in this study. They were divided into 3 groups according to their age (4 years and under, 5 to 6 years and 7 years and over). During the search, 7 patients were excluded: due to the image rights not granted. The data were collected and analyzed by 2 observers. Then a randomization took place thus creating a sample of 15 children divided into 3 same groups. The data were collected and analyzed by 20 practitioner observers
Key inclusion criteria (1 listed)
- be in the correct age group and agree to participate in the study
Key exclusion criteria (1 listed)
- not be in the right age group, refuse to participate in the study
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 |
|---|---|---|
| ParentsTo observe the influence of the parents/caregivers behavior on their child during dental treatment | Behavioural | 4 years and under, 5 to 6 years, 7 years and over |
Primary outcome
Parent behavior/Child Behavior
Time frame: Two weeks
By hetero-evaluation scale, 20 dentists will estimate the behavior of parents and children. The measurements via the observation of filmed sessions were carried out thanks to two views.
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 30 Aug 2021.
- 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.
Tania Vanhee, DDS principal investigator
Université Libre de Bruxelles
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 Behavior, Child and Parents, run by Université Libre de Bruxelles at 1 site in Belgium.
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 30 Aug 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 Belgium. 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?
Parent behavior/Child Behavior (time frame: Two weeks). 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 30 Aug 2021.