Children's Drawing as a Projective Tool to Assess Dental... | NCT06369038

Studies
Children's Drawing as a Projective Tool to Assess Dental Anxiety

NCT06369038

Sponsor

Cairo University

Status

Not yet recruiting

Last Update Posted

Sep 5, 2024Actual

Enrollment

138Estimated

Phase

Not provided

Conditions

Dental Anxiety

Interventions

observation of level of dental anxiety in children

Countries

Not provided

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 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2024Estimated

Primary Completion Date

Aug 30, 2025Estimated

Completion Date

Dec 30, 2025Estimated

First Submitted Date

Apr 12, 2024

First Submission Date that Met QC Criteria

Apr 12, 2024

First Posted Date

Apr 16, 2024Actual

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 31, 2024

Last Update Posted Date

Sep 5, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Weam Sayed Abd El Mautie, pediatric dental resident at faculty of dentistry Cairo university, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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 in this study is to compare the results of anxiety measurement of the child using the CD:H scale with the long-used Face,Legs,Activity,Cry and Consolability scale (FLACC scale) , Frankl behaviour rating scale and pulse oximeter reading, to see if the drawing alone can be a reliable tool to predict the child's behaviour before the dental procedure.

Detailed Description

Dental anxiety is one of the major problems facing us in pediatric dentistry, the new experience that the child has to go through together with the difficulty for the child to express his exact cause of fear increases the problem.

Research has shown that healthcare providers spend more time communicating with parents than pediatric patients. In a typical medical care visit, less than 20% of the communication engaged pediatric patients, regardless of age. Most decision-making and treatment planning are done by dentists and parents.

Even when the dentist tries to engage the child in the conversation it usually includes the social aspect "his favourite hobby, toys, school topics, etc…" rather than the medical history or treatment decisions so the child is unaccustomed to discussing his dental fears and complaints to the dentist, hence we lose a lot of the child's trust.

Drawing has been used in literature as a psychological method to express one's thoughts and fears and can be analyzed by the healthcare provider to know the deeper thoughts of the child.

Thus, the current study aims to deeply understand the children's point of view towards dental treatment and use the drawings as a projective tool to assess the dental anxiety in those children by simple index and defined scores that every dentist could learn and apply.

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

138Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
observation of level of dental anxiety in children	Behavioral	analysis of children's drawings using CD:H index

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
FLAAC behavioral scale	scale to measure the level of anxiety for children during dental visit	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged from 6 to 12 years.
Children with past dental experience.
One or more primary teeth indicated for simple extraction procedure.

Exclusion Criteria:

Patients lacking cooperative behavior (very young age and patients with certain medical or psychological disorders) according to Wright's classification.
Refusal of participation.
Lack of informed consent by the child's parents.
If the child shows any signs of disinterest in drawing.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

children with previous dental experience aging from 6 to 12 years and have one or more teeth indicated for simple extraction.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Weam S Ayoub, MsC	Contact	01093060952		weam.sayed@dentistry.cu.edu.eg
Reem MO Wahby, PhD	Contact	01122788078		reem.wahby@dentistry.cu.edu.eg

Overall Officials

Name	Affiliation	Role
Weam S Ayoub, MsC	Cairo University	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28598183	Background	Cianetti S, Lombardo G, Lupatelli E, Pagano S, Abraha I, Montedori A, Caruso S, Gatto R, De Giorgio S, Salvato R. Dental fear/anxiety among children and adolescents. A systematic review. Eur J Paediatr Dent. 2017 Jun;18(2):121-130. doi: 10.23804/ejpd.2017.18.02.07.
21410359	Background	Facco E, Zanette G, Favero L, Bacci C, Sivolella S, Cavallin F, Manani G. Toward the validation of visual analogue scale for anxiety. Anesth Prog. 2011 Spring;58(1):8-13. doi: 10.2344/0003-3006-58.1.8.