NCT06369038

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

October 30, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

September 5, 2024

Status Verified

August 1, 2024

Enrollment Period

10 months

First QC Date

April 12, 2024

Last Update Submit

August 31, 2024

Conditions

Keywords

dental anxietydrawingprojective tool

Outcome Measures

Primary Outcomes (1)

  • FLAAC behavioral scale

    scale to measure the level of anxiety for children during dental visit

    6 months

Interventions

analysis of children's drawings using CD:H index

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 28598183BACKGROUND
  • 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.

    PMID: 21410359BACKGROUND
  • Clatworthy S, Simon K, Tiedeman ME. Child drawing: hospital--an instrument designed to measure the emotional status of hospitalized school-aged children. J Pediatr Nurs. 1999 Feb;14(1):2-9. doi: 10.1016/S0882-5963(99)80054-2.

    PMID: 10063243BACKGROUND
  • Voepel-Lewis T, Zanotti J, Dammeyer JA, Merkel S. Reliability and validity of the face, legs, activity, cry, consolability behavioral tool in assessing acute pain in critically ill patients. Am J Crit Care. 2010 Jan;19(1):55-61; quiz 62. doi: 10.4037/ajcc2010624.

    PMID: 20045849BACKGROUND

Study Officials

  • Weam S Ayoub, MsC

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pediatric dental resident at faculty of dentistry Cairo university

Study Record Dates

First Submitted

April 12, 2024

First Posted

April 16, 2024

Study Start

October 30, 2024

Primary Completion

August 30, 2025

Study Completion

December 30, 2025

Last Updated

September 5, 2024

Record last verified: 2024-08