Dental AnxietyNCT06369038
Children's Drawing as a Projective Tool to Assess Dental Anxiety
An observational study of Dental Anxiety, run by Cairo University.
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) , Frankl behaviour rating scale and pulse oximeter reading, to see if the drawing alone can be a reliable tool to predict the child's… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- observation of level of dental anxiety in children
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2024to 30 Dec 2025
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children with previous dental experience aging from 6 to 12 years and have one or more teeth indicated for simple extraction.
Who may be able to join
- Children aged from 6 to 12 years.
- Children with past dental experience.
- One or more primary teeth indicated for simple extraction procedure.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Dental Anxiety After Children's Drawing as a Projective Tool During Dental Extraction Under Local Anesthesia - A Diagnostic Accuracy Test Study.
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.
Read the 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.
- Conditions
- Dental Anxiety
- Being tested
- observation of level of dental anxiety in children
- Keywords
- dental anxiety, drawing, projective tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation of level of dental anxiety in childrenBehavioural
analysis of children's drawings using CD:H index
What is being measured
The primary outcome is the main question the study is designed to answer.
FLAAC behavioral scale
scale to measure the level of anxiety for children during dental visit
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start30 Oct 2024 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weam Sayed Abd El Mautie, Cairo University
- Investigators
- Weam S Ayoub, MsC, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369038
- Sponsor's protocol ID
- CUP3222024
- Status last verified
- Aug 2024
- First submitted
- 12 Apr 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28598183Facco 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.
PubMed 21410359Clatworthy 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.
PubMed 10063243Voepel-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.
PubMed 20045849
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dental Anxiety After Children's Drawing as a Projective Tool During Dental Extraction Under Local Anesthesia - A Diagnostic Accuracy Test Study.
- ClinicalTrials.gov ID
- NCT06369038
- Acronym / sponsor ID
- CUP3222024
- Conditions
- Dental Anxiety
- Keywords
- dental anxiety, drawing, projective tool
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 16 Apr 2024 (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 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children with previous dental experience aging from 6 to 12 years and have one or more teeth indicated for simple extraction.
Key inclusion criteria (3 listed)
- Children aged from 6 to 12 years.
- Children with past dental experience.
- One or more primary teeth indicated for simple extraction procedure.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| observation of level of dental anxiety in childrenanalysis of children's drawings using CD:H index | Behavioural | – |
Primary outcome
FLAAC behavioral scale
Time frame: 6 months
scale to measure the level of anxiety for children during dental visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Background: PubMed 28598183Cianetti 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.
- Background: PubMed 21410359Facco 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.
- Background: PubMed 10063243Clatworthy 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.
- Background: PubMed 20045849Voepel-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.
- Individual participant dataSharing planned: Undecided
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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.
Weam S Ayoub, MsC principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Anxiety, run by Cairo University.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weam S Ayoub, MsC (01093060952, weam.sayed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLAAC behavioral scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06369038, which also lists 4 linked publications.
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 5 Sep 2024.