- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06350513
The Effect of Animated Movies and Storybooks on Fear and Anxiety Levels in Children With Type 1 Diabetes
The Effect of Animated Film and Storybook on Fear and Anxiety Levels in Children With Newly Diagnosed Type 1 Diabetes: Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emine GEÇKİL, Prof. Dr.
- Phone Number: 05066285460
- Email: eminegeckil@gmail.com
Study Locations
-
-
-
Konya, Turkey
- Necmettin Erbakan University
-
-
Meram
-
Konya, Meram, Turkey
- Semra Köse
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteering to participate in the study,
- Parental approval
- Being between the ages of 7-12,
- Being diagnosed with T1D for the first time,
- Being literate and able to communicate in Turkish
Exclusion Criteria:
- Having a mental, visual, hearing or communication impairment,
- Having mental and spiritual health problems,
Study Plan
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 |
---|---|
Experimental: Animation movie, story book
Animation movie: For this study, an animated film (Professor bumblebee animation) prepared for newly diagnosed children with type 1 diabetes will be shown in the experimental group. This is an approximately 10 minute film produced by Life for a children's center in New South Wales (DIABETES AUSTRALIA). The animated film will be translated into Turkish and sent to experts (specialists in the field of Children and Diabetes) for expert opinion. It will be shown to children after all permissions have been obtained following expert opinions. This animated movie is a guide to diabetes for children. Additionally, the storybook will be given as a gift for the children in the experimental group to read. Story Book: It is an educational booklet version of the Professor Bumblebee animation translated into Turkish and illustrated. The aim here is to serve as an auxiliary tool for newly diagnosed T1D children to look at later and where they are confused. |
Animation movie: For this study, an animated film (Professor bumblebee animation) prepared for newly diagnosed children with type 1 diabetes will be shown in the experimental group. This is an approximately 10 minute film produced by Life for a children's center in New South Wales (DIABETES AUSTRALIA). The animated film will be translated into Turkish and sent to experts (specialists in the field of Children and Diabetes) for expert opinion. It will be shown to children after all permissions have been obtained following expert opinions. This animated movie is a guide to diabetes for children. Additionally, the storybook will be given as a gift for the children in the experimental group to read. Story Book: It is an educational booklet version of the Professor Bumblebee animation translated into Turkish and illustrated. The aim here is to serve as an auxiliary tool for newly diagnosed T1D children to look at later and where they are confused. |
Other: control group
No applications will be made.
|
Animation movie: For this study, an animated film (Professor bumblebee animation) prepared for newly diagnosed children with type 1 diabetes will be shown in the experimental group. This is an approximately 10 minute film produced by Life for a children's center in New South Wales (DIABETES AUSTRALIA). The animated film will be translated into Turkish and sent to experts (specialists in the field of Children and Diabetes) for expert opinion. It will be shown to children after all permissions have been obtained following expert opinions. This animated movie is a guide to diabetes for children. Additionally, the storybook will be given as a gift for the children in the experimental group to read. Story Book: It is an educational booklet version of the Professor Bumblebee animation translated into Turkish and illustrated. The aim here is to serve as an auxiliary tool for newly diagnosed T1D children to look at later and where they are confused. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
State Anxiety Inventory for Children (STAI-C)
Time Frame: Initial assessment will be performed at baseline (pre-intervention)
|
This scale was developed to evaluate children's state and trait anxiety and is in a self-report form.
As a result of some procedures, the scale was turned into 2 separate scales containing a total of 40 items (20 state and 20 trait anxiety items).
Although the validity and reliability of the scale has been done for children aged 9-12, the scale can be used until the age of 17 because it is difficult for children over the age of 12 to understand the adult anxiety scale.
In the State Anxiety Scale for Children, children are asked to mark one of three options regarding how they evaluate how they feel at that moment.
The scale aims to evaluate emotions related to state anxiety such as tension, irritability, rush, and uneasiness.
The highest score that can be obtained from the State Anxiety Scale is 60 and the lowest score is 20.
Cronbach's α value was found to be 0.82
|
Initial assessment will be performed at baseline (pre-intervention)
|
State Anxiety Inventory for Children (STAI-C)
Time Frame: The second evaluation will be made after the first evaluation (after watching the animated movie and reading the story book (approximately 1 hour later)).
|
This scale was developed to evaluate children's state and trait anxiety and is in a self-report form.
As a result of some procedures, the scale was turned into 2 separate scales containing a total of 40 items (20 state and 20 trait anxiety items).
Although the validity and reliability of the scale has been done for children aged 9-12, the scale can be used until the age of 17 because it is difficult for children over the age of 12 to understand the adult anxiety scale.
In the State Anxiety Scale for Children, children are asked to mark one of three options regarding how they evaluate how they feel at that moment.
The scale aims to evaluate emotions related to state anxiety such as tension, irritability, rush, and uneasiness.
The highest score that can be obtained from the State Anxiety Scale is 60 and the lowest score is 20.
Cronbach's α value was found to be 0.82
|
The second evaluation will be made after the first evaluation (after watching the animated movie and reading the story book (approximately 1 hour later)).
|
State Anxiety Inventory for Children (STAI-C)
Time Frame: The third evaluation will be made approximately 3 days after the second evaluation.
|
This scale was developed to evaluate children's state and trait anxiety and is in a self-report form.
As a result of some procedures, the scale was turned into 2 separate scales containing a total of 40 items (20 state and 20 trait anxiety items).
Although the validity and reliability of the scale has been done for children aged 9-12, the scale can be used until the age of 17 because it is difficult for children over the age of 12 to understand the adult anxiety scale.
In the State Anxiety Scale for Children, children are asked to mark one of three options regarding how they evaluate how they feel at that moment.
The scale aims to evaluate emotions related to state anxiety such as tension, irritability, rush, and uneasiness.
The highest score that can be obtained from the State Anxiety Scale is 60 and the lowest score is 20.
Cronbach's α value was found to be 0.82
|
The third evaluation will be made approximately 3 days after the second evaluation.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Children's Fear Scale
Time Frame: Initial assessment will be performed at baseline (pre-intervention)
|
The child fear scale was designed to measure a child's anxiety level and is intended to be used in children between the ages of 5-10.
However, some suggest that it can also be used in children up to the age of 12.
The child is shown five facial expressions (ranging from zero to four), each representing a level on the scale.
Zero and four; Zero indicates no fear or anxiety, and four indicates high levels of fear and anxiety.
This scale can be used to measure fear and anxiety before and during the procedure.
Cohen's Kappa coefficient was checked to determine interobserver agreement.
|
Initial assessment will be performed at baseline (pre-intervention)
|
Children's Fear Scale
Time Frame: The second evaluation will be made after the first evaluation (after watching the animated movie and reading the story book (approximately 1 hour later)).
|
The child fear scale was designed to measure a child's anxiety level and is intended to be used in children between the ages of 5-10.
However, some suggest that it can also be used in children up to the age of 12.
The child is shown five facial expressions (ranging from zero to four), each representing a level on the scale.
Zero and four; Zero indicates no fear or anxiety, and four indicates high levels of fear and anxiety.
This scale can be used to measure fear and anxiety before and during the procedure.
Cohen's Kappa coefficient was checked to determine interobserver agreement.
|
The second evaluation will be made after the first evaluation (after watching the animated movie and reading the story book (approximately 1 hour later)).
|
Children's Fear Scale
Time Frame: The third evaluation will be made approximately 3 days after the second evaluation.
|
The child fear scale was developed by McMurtry et al. in 2011.
The Turkish validity of the scale was determined by Gerçeker et al.
It was made by in 2018.
The child fear scale was designed to measure a child's anxiety level and is intended to be used in children between the ages of 5-10.
However, some suggest that it can also be used in children up to the age of 12.
The child is shown five facial expressions (ranging from zero to four), each representing a level on the scale.
Zero and four; Zero indicates no fear or anxiety, and four indicates high levels of fear and anxiety.
This scale can be used to measure fear and anxiety before and during the procedure.
Cohen's Kappa coefficient was checked to determine interobserver agreement.
|
The third evaluation will be made approximately 3 days after the second evaluation.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NecmettinE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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