Diabetes Mellitus, Type 1NCT06350513
The Effect of Animated Movies and Storybooks on Fear and Anxiety Levels in Children With Type 1 Diabetes
A study testing Animation movie, story book in people with Diabetes Mellitus, Type 1 and Child, Only, run by Selverhan Yurttutan at 3 sites in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of animated films and story books on the fear and anxiety levels of children with newly diagnosed type 1 diabetes. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1, Child, Only, Anxiety
- What is being tested?
- Animation movie, story book
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 25 Feb 2024to 25 Jul 2026
- Phase
- Interventional
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Having a mental, visual, hearing or communication impairment,
- Having mental and spiritual health problems,
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
NecmettinEU
Konya, Meram, 06480
Semra Köse
Konya, Meram
Necmettin Erbakan Üniversity
Konya
About this study
Official title: The Effect of Animated Film and Storybook on Fear and Anxiety Levels in Children With Newly Diagnosed Type 1 Diabetes: Randomized Controlled Study
This study aims to evaluate the effects of animated films and story books on the fear and anxiety levels of children with newly diagnosed type 1 diabetes.
Read the detailed description
This study aims to evaluate the effects of animated films and story books on the fear and anxiety levels of children with newly diagnosed type 1 diabetes. In the study, newly diagnosed children in the experimental group will be shown a 10-minute movie and read the educational booklet. Routine care will continue for the control group.
- Conditions
- Diabetes Mellitus, Type 1, Child, Only, Anxiety, Fear, Nurse
- Being tested
- Animation movie, story book
- Medical subject headings
- Diabetes Mellitus, Type 1, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animation movie, story bookOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Animation movie, story book | Experimental | 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. Receives: Other: Animation movie, story book |
| control group | Other | No applications will be made. Receives: Other: Animation movie, story book |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Inventory for Children (STAI-C)
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
Measured: Initial assessment will be performed at baseline (pre-intervention)
State Anxiety Inventory for Children (STAI-C)
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
Measured: 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)
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
Measured: The third evaluation will be made approximately 3 days after the second evaluation.
Secondary outcomes (3)
Children's Fear Scale
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.
Measured: Initial assessment will be performed at baseline (pre-intervention)
Children's Fear Scale
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.
Measured: 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
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.
Measured: The third evaluation will be made approximately 3 days after the second evaluation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start25 Feb 2024
- Primary completion25 Jun 2026
- Study completion25 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Group (Experiment-Control) Randomized Controlled Experimental
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selverhan Yurttutan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Selverhan Yurttutan, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350513
- Sponsor's protocol ID
- NecmettinE
- Status last verified
- Aug 2026
- First submitted
- 15 Mar 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Animated Film and Storybook on Fear and Anxiety Levels in Children With Newly Diagnosed Type 1 Diabetes: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06350513
- Acronym / sponsor ID
- NecmettinE
- Conditions
- Diabetes Mellitus, Type 1, Child, Only, Anxiety, Fear, Nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Selverhan YurttutanUniversity, hospital or other
- Study start
- 25 Feb 2024 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 25 Jul 2026 (actual)
- First posted
- 5 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.
This study aims to evaluate the effects of animated films and story books on the fear and anxiety levels of children with newly diagnosed type 1 diabetes.
Detailed description
This study aims to evaluate the effects of animated films and story books on the fear and anxiety levels of children with newly diagnosed type 1 diabetes. In the study, newly diagnosed children in the experimental group will be shown a 10-minute movie and read the educational booklet. Routine care will continue for the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Group (Experiment-Control) Randomized Controlled Experimental
| Arm | Type | Receives |
|---|---|---|
| Animation movie, story book | Experimental | Other: Animation movie, story bookAnimation 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. |
| control group | Other | Other: Animation movie, story bookNo applications will be made. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Having a mental, visual, hearing or communication impairment,
- Having mental and spiritual health problems,
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 |
|---|---|---|
| Animation movie, story bookAnimation 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 | Animation movie, story book, control group |
Primary outcome
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
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
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
3 secondary outcomes
Children's Fear Scale
Time frame: 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)).
Children's Fear Scale
Time frame: The third evaluation will be made approximately 3 days after the second evaluation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animation movie, story book in people with Diabetes Mellitus, Type 1 and Child, Only, run by Selverhan Yurttutan at 3 sites in Turkey (Türkiye).
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety Inventory for Children (STAI-C) (time frame: Initial assessment will be performed at baseline (pre-intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2026.