Validation of Child Drawing Hospital Scale (CD: H) and the Place of the Drawing in the Evaluation of Dental Anxiety
Primary Purpose
Dental Anxiety, Dental Pain, Validation
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
survey research
Sponsored by

About this trial
This is an interventional other trial for Dental Anxiety
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
Sites / Locations
- Gaziosmanpaşa University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CD:H Scale
Arm Description
Pictures drawn using the CD:H Scale were evaluated.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT05236101
First Posted
January 20, 2022
Last Updated
February 1, 2022
Sponsor
Tokat Gaziosmanpasa University
1. Study Identification
Unique Protocol Identification Number
NCT05236101
Brief Title
Validation of Child Drawing Hospital Scale (CD: H) and the Place of the Drawing in the Evaluation of Dental Anxiety
Official Title
Validation of Child Drawing Hospital Scale (CD: H) and the Place of the Drawing in the Evaluation of Dental Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 20, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
May 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety, Dental Pain, Validation, Child Drawing Hospital Scale
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
235 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CD:H Scale
Arm Type
Experimental
Arm Description
Pictures drawn using the CD:H Scale were evaluated.
Intervention Type
Behavioral
Intervention Name(s)
survey research
Intervention Description
Children with dental treatment were asked to draw pictures.
Primary Outcome Measure Information:
Title
Turkish Validation of the Child Drawing Hospital Scale
Description
Using the Child Drawing Hospital Scale, the pictures drawn by the patients were interpreted and scored by two researchers (minimum 15, max 205).
Time Frame
12 week
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Gaziosmanpaşa University
City
Tokat
ZIP/Postal Code
60100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Validation of Child Drawing Hospital Scale (CD: H) and the Place of the Drawing in the Evaluation of Dental Anxiety
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