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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06369038
Other study ID # CUP3222024
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 30, 2024
Est. completion date December 30, 2025

Study information

Verified date April 2024
Source Cairo University
Contact Weam S Ayoub, MsC
Phone 01093060952
Email weam.sayed@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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) 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 138
Est. completion date December 30, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
observation of level of dental anxiety in children
analysis of children's drawings using CD:H index

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary FLAAC behavioral scale scale to measure the level of anxiety for children during dental visit 6 months
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