- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06142227
The Effect of Reading a Pictorial Storybook on Children's Fear, Anxiety and Emotional Symptoms Before Dental Treatment
November 16, 2023 updated by: Gamze Akay
The Effect of Reading a Pictorial Storybook on Children's Fear, Anxiety and Emotional Symptoms Before Dental Treatment: A Randomised Controlled Study
The aim of this study was to determine the effect of reading a picture storybook on children's fear, anxiety and emotional symptoms before dental treatment.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
In children with receiving dental treatment will be randomly divided into two groups: picture storybook group and control.
Interventions will be applied for only 1 times.
While the illustrated storybook is read to the experimental group, no intervention will be applied to the control group.
The children will be assessed before, during and after.
Fear, anxiety and emotional symptoms due to dental treatment procedure will be evaluated using the Children's Emotional Indicator Scale, Child Anxiety Scale-Stateness and Children's Fear Scale.
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gamze AKAY, 1
- Phone Number: (531) 453 66 61
- Email: gamzeakay_25@artvin.edu.tr
Study Contact Backup
- Name: Fatma GÜDÜCÜ TÜFEKCİ, 2
- Phone Number: (531) 453 66 61
- Email: fatma.guducutufekci@atauni.edu.tr
Study Locations
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-
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Artvin, Turkey, 08000
- Artvin Oral and Dental Health Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- No audiovisual impairment,
- Being open to communication and
- Must be accompanied by a parent.
Exclusion Criteria:
- Having special needs,
- Having an audio-visual impairment,
- Learning difficulties or mental retardation and
- Children whose parents do not agree to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
Routine dental treatment will be applied to the control group.
No action will be taken.
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Experimental: Experimental Group
Before dental treatment, the child will be read a story book with pictures of the dental clinic.
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The pictorial storybook by children will be chosen by child psychologists.
The book will be read to children by researcher.
The researcher has a fairy tale therapy certificate.
The pictorial storybook reading will start 15 minutes before the dental treatment process and will be completed before the treatment process begins..
The pictorial storybook will be read to children only one time.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic Information Form
Time Frame: baseline
|
It is a form consisting of a total of 13 questions including the child's age, gender, diagnosis, duration of treatment, number of treatments (How many times did the child come to the clinic?), the status of receiving information about dental treatment and the person who received the information, the education level and occupation of the mother and father, the place where the family lives and the economic situation.
It was prepared by the researchers in line with the literature.
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baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child anxiety Scale-State
Time Frame: baseline
|
"Child Anxiety Scale-State" scale developed by Ersig et al. in 2013 measures the state anxiety of children aged 4-10 years.
In 2017, Gerceker et al. carried out Turkish validity study for the scale.
CAS-S (State) is designed as a thermometer.
At the bottom is the bulb chamber, and upward are horizontal lines.
Each horizontal line represents a score, and the thermometer has 10 points.
The bulb chamber at the bottom is 0 points and indicates that there is no anxiety.
It is interpreted as the rise of anxiety as it rises upwards.
The peak is worth 10 points and refers to the highest anxiety.
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baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Fear Scale
Time Frame: baseline
|
This scale was developed by McMurtry et al. in 2011.
In 2018, Gerceker et al. carried out a Turkish validity study for the scale.
The scale is aimed at children aged 5-10 years.
The facial muscle changes in fearful expressions are drawn by a graphic artist based on photos of frightened faces.
In this scale, the child is shown a scale containing five facial expressions that are evaluated between 0 and 4 points.
While 0 point refers to no fear; 4 points refers to the highest fear.
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baseline
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The Children's Emotional Indicator Scale
Time Frame: baseline
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The Children's Emotional Indicator Scale (CEAS) was developed by Li and Lopez and its Turkish validity and reliability was conducted by Çimke and Bayat.
The scale consists of five categories of observable emotional behaviours (Facial expression, Vocalization, Activity, Interaction, and Level of cooperation).
Each category has a value between 1-5.
The total score that can be obtained from the scale varies between 5-25.
The higher the scores obtained from the scale, the higher the negative emotional indicators.
Cronbach's alpha value of the scale was 0.92.
In the Turkish validity and reliability study of the scale, Cronbach's alpha value was determined as 0.94.
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baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Ayşe TAŞTAN, 3, Artvin Çoruh University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Alsaadoon AM, Sulimany AM, Hamdan HM, Murshid EZ. The Use of a Dental Storybook as a Dental Anxiety Reduction Medium among Pediatric Patients: A Randomized Controlled Clinical Trial. Children (Basel). 2022 Mar 1;9(3):328. doi: 10.3390/children9030328.
- Aminabadi NA, Vafaei A, Erfanparast L, Oskouei SG, Jamali Z. Impact of pictorial story on pain perception, situational anxiety and behavior in children: a cognitive-behavioral schema. J Clin Pediatr Dent. 2011 Winter;36(2):127-32. doi: 10.17796/jcpd.36.2.3163251527508338.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2023
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
May 30, 2024
Study Registration Dates
First Submitted
November 16, 2023
First Submitted That Met QC Criteria
November 16, 2023
First Posted (Estimated)
November 21, 2023
Study Record Updates
Last Update Posted (Estimated)
November 21, 2023
Last Update Submitted That Met QC Criteria
November 16, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- Audio book for children
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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