Validation of Child Drawing Hospital Scale (CD: H) and th... | NCT05236101

Studies
Validation of Child Drawing Hospital Scale (CD: H) and the Place of the Drawing in the Evaluation of Dental Anxiety

NCT05236101

Sponsor

Tokat Gaziosmanpasa University

Status

Completed

Last Update Posted

Feb 11, 2022Actual

Enrollment

235Actual

Phase

Not Applicable

Conditions

Dental Anxiety
Dental Pain
Validation
Child Drawing Hospital Scale

Interventions

survey research

Countries

Turkey (Türkiye)

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

Feb 2022

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

Nov 20, 2018Actual

Primary Completion Date

Aug 1, 2019Actual

Completion Date

May 10, 2020Actual

First Submitted Date

Jan 20, 2022

First Submission Date that Met QC Criteria

Feb 1, 2022

First Posted Date

Feb 11, 2022Actual

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

Feb 1, 2022

Last Update Posted Date

Feb 11, 2022Actual

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

Objectives: Our study aimed to perform a Turkish validation study of the Child Drawing: Hospital (CD:H) Scale and evaluate the dental anxiety and pain experienced during the treatment by drawing.

Study Design: Pediatric patients between the ages of 4-13 who applied to the Pediatric Dentistry Department between 2018-2020 were included in the study. Following the translation of the CD:H Scale into Turkish and linguistic-cultural validation, the behaviors of pediatric patients during treatment were evaluated with the Frankl Behavior Rating Scale, the pain they experienced during treatment with the Wong- Baker Face Rating Scale, and their anxiety levels were evaluated with the pictures drawn by the patients at the end of the treatment. The data were analyzed with Statistical Package for the Social Sciences v23, and the significance level was taken as p <0.05.

Results: Within the scope of the scale's reliability-validity study, the Intra-Class Correlation Coefficient (ICC) was evaluated with test-retest consistency. For section A,B,C and total score reliability was found to be positive and strong level correlation. Dental anxiety of boys was higher than girls.

Conclusions: The Turkish version of the CD:H Scale is a reliable and valid scale that can be used to evaluate the dental anxiety of Turkish pediatric patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

235Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CD:H Scale	Experimental	Pictures drawn using the CD:H Scale were evaluated.	Behavioral: survey research

Interventions

Name	Type	Description	Arm Group Labels	Other Names
survey research	Behavioral	Children with dental treatment were asked to draw pictures.	CD:H Scale

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Turkish Validation of the Child Drawing Hospital Scale	Using the Child Drawing Hospital Scale, the pictures drawn by the patients were interpreted and scored by two researchers (minimum 15, max 205).	12 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have toothache and who have undergone dental treatment (filling and root canal treatment)
Patients with deep dentin caries who need local anesthesia
Children between the ages of 4-13
Patients who are willing to paint and understand commands
Patients without any mental or physical disability
Patients whose parents agreed to participate in the study and signed their consent

Exclusion Criteria:

Children not aged 4-13
Patients with mild to moderate caries who do not need local anesthesia
Patients who are not willing to paint
Patients with inadequate hand coordination
Patients with motor dysfunction
Children with any systemic illness
Patients with mental or physical disabilities
Patients with any syndrome
Patients with color blindness
Children whose native language is not Turkish
Patients whose parents refused to participate in the study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

13 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gaziosmanpaşa University		Tokat Province		60100	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39984891	Derived	Ozdemir Celik DS, Deniz E, Demir O, Altan H. Validation of child drawing hospital (CD: H) scale and the role of drawing in the evaluation of Dental anxiety. BMC Oral Health. 2025 Feb 21;25(1):274. doi: 10.1186/s12903-025-05605-2.

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D005157	Facial Pain
D010146	Pain