The Influence of Parental Behavior on the Course of the P... | NCT05026515

Studies
The Influence of Parental Behavior on the Course of the Pediatric Dentistry Session

NCT05026515

Sponsor

Université Libre de Bruxelles

Status

Completed

Last Update Posted

Aug 30, 2021Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Behavior, Child
Parents
Dental Anxiety

Interventions

Parents

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 13, 2020Actual

Primary Completion Date

Dec 13, 2020Actual

Completion Date

Mar 2, 2021Actual

First Submitted Date

Apr 24, 2021

First Submission Date that Met QC Criteria

Aug 23, 2021

First Posted Date

Aug 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2021

Last Update Posted Date

Aug 30, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
4 years and under	Children coming at dental appointment, aged 4 years and under	Behavioral: Parents
5 to 6 years	Children coming at dental appointment, aged 5 to 6 years	Behavioral: Parents
7 years and over	Children coming at dental appointment, aged 7 years and over	Behavioral: Parents

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Parents	Behavioral	To observe the influence of the parents/caregivers behavior on their child during dental treatment	4 years and under 5 to 6 years

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Two weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

be in the correct age group and agree to participate in the study

Exclusion Criteria:

not be in the right age group, refuse to participate in the study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

14 Years

Standard Ages

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tania Vanhee, DDS	Université Libre de Bruxelles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tania Vanhée		Brussels		1000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D002652	Child Behavior

ID	Term
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D015406	Single Parent

Ancestor Terms

ID	Term
D012847	Single Person
D017533	Marital Status
D005191	Family Characteristics
D003710	Demography

Browse Leaves

Not provided

Browse Branches

Not provided