Type 1 Diabetes in ChildrenNCT07107789
The Effect of Diabetes Education Given With Video Animation on Metabolic Control, Self-Care Ability, and Attitudes Towards the Disease in Children With Type 1 Diabetes
A study testing Diabetes education with video animation in people with Type 1 Diabetes in Children, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the attitude towards the disease, perceived social support systems, metabolic control and self-care ability of pediatric patients diagnosed with Type 1 diabetes, by giving video animation training considering their age and developmental level. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Type 1 Diabetes in Children
- What is being tested?
- Diabetes education with video animation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2025to 6 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Agreeing to participate in the study
- Diagnosed with Type 1 DM by a specialist
- Diagnosed with Type 1 diabetes for at least 6 months
- Being between the ages of 11 and 18
- Using an insulin pen
- Not using an insulin pump
- Coming for regular checkups at the Pediatric Endocrinology clinic
- Having no other chronic disease besides diabetes
Who cannot join
- Using an insulin pump
- Not being mentally healthy
- Having any mental or physical disability
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Erzurum City Hospital
Erzurum, Palandöken, 25240
About this study
Official title: The Effect of Diabetes Education Delivered Through Video Animation on Metabolic Control, Self-Care Ability, Perceived Social Support, and Attitudes Toward the Disease in Children With Type 1 Diabetes
The aim of this study is to evaluate the attitude towards the disease, perceived social support systems, metabolic control and self-care ability of pediatric patients diagnosed with Type 1 diabetes, by giving video animation training considering their age and developmental level. The main questions it aims to answer are:
- Nursing interventions using video animations increase self-care abilities in children aged 11-18.
- Nursing interventions using video animations increase the perception of social support in children aged 11-18.
- Nursing interventions using video animations support metabolic control in children aged 11-18.
- Nursing interventions using video animations positively affect the attitudes of children aged 11-18 toward their illness.
Read the detailed description
With the development and proliferation of technology, an essential part of our daily lives, adaptation and developments in technology have begun to increase in the healthcare sector. Research has shown that games and video animations are effective methods beyond medication. No studies have been found in the literature evaluating the effects of diabetes education provided through video animation on the metabolic control, self-care abilities, and attitudes toward the disease in children with Type 1 diabetes. Therefore, the aim of this study is to evaluate the effects of video animation education given to children diagnosed with Type 1 diabetes on their attitudes toward the disease, perception of social support, and self-care abilities. It is anticipated that this research will provide a proactive, multifaceted approach to care and treatment. The study was designed as a pretest/posttest randomized controlled trial. The study population consisted of children aged 11-18 who were regularly followed in the outpatient clinic and had been diagnosed with Type 1 diabetes for at least 6 months. Children who accepted the study and met the criteria were assigned to the video animation and control groups using a block randomization method. The study sample was determined to be 80 individuals, 40 in the experimental group and 40 in the control group. The video animation scenario to be used in the study was created by the researchers in parallel with the routine diabetes education provided at the hospital, and expert approval was obtained. The video animation scenes were prepared by a voice actor and illustrator as part of the project. The experimental group will receive diabetes education through video animation following the routine diabetes education provided by the hospital. Pre- and post-intervention surveys will be administered. The control group will receive routine diabetes education from the hospital's diabetes nurse. No other intervention will be administered. Pre-tests/post-tests and surveys will be administered before and after the diabetes education.
- Conditions
- Type 1 Diabetes in Children
- Being tested
- Diabetes education with video animation
- Keywords
- child, diabetes, animation, education, metabolic, control, self-care
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes education with video animationOther
Providing diabetes education to the experimental group through a video animation Following the routine diabetes education provided by the hospital, the experimental group will receive diabetes education using a video animation prepared and staged by the researcher and approved by experts.
| Study group | Role | What they receive |
|---|---|---|
| The experimental group will receive diabetes education through video animation. | Active comparator | Following the routine diabetes education provided by the hospital, the experimental group will receive diabetes education using a video animation prepared by the researcher and approved by an expert. Pre- and post-intervention surveys will be administered. Receives: Other: Diabetes education with video animation |
| Control group to receive routine diabetes education | No intervention | The control group will receive routine diabetes education from the hospital's diabetes nurse. No intervention will be applied. Only the scale and pre-test/post-test will be administered to the control groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Control
Weight and height measurements will be combined to report body mass index in kg/m². Fasting and postprandial blood glucose values and HbA1C values will be evaluated.
Measured: three weeks
Self-care power
The five-point Likert-type self-care agency scale, which offers an opportunity for self-assessment, consists of 35 questions. The total score obtained from the scale ranges from 35 to 140. A higher total score indicates that the patient is more independent and competent in self-care.
Measured: three weeks
Attitude Towards One's Own Illness
It provides an opportunity to assess the attitudes children with chronic illness develop toward their illness. A 13-item, five-point Likert-type scale was designed to self-report children with chronic illnesses. Four of the 13 items are bipolar (very good, somewhat good, not sure, somewhat bad, very bad), while nine items assess how often children experience positive or negative feelings specific to having a chronic illness, using the phrases "very often, often, sometimes, not often, never." Mean scores for items measuring children's attitudes toward their illnesses range from 1 to 5. The lowest possible total score is 13, and the highest is 65. There are no reverse items. Scores of 1 and 2 indicate a negative attitude, 3 indicate a neutral attitude, and 4 and 5 indicate a positive attitude. The internal consistency coefficient of the scale was determined to be 0.79.
Measured: three weeks
Multifaceted Perceived Social Support
The total score available ranges from 12 to 84. A higher score indicates a positive perception of social support.
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion6 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes in ChildrenStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Two groups, the traditional experimental and control groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Nur Yılmaz, Ataturk University
- Investigators
- Gamze Nur YILMAZ, PhD, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107789
- Sponsor's protocol ID
- AU-SBE-GNY-01
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diabetes Education Delivered Through Video Animation on Metabolic Control, Self-Care Ability, Perceived Social Support, and Attitudes Toward the Disease in Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07107789
- Acronym / sponsor ID
- AU-SBE-GNY-01
- Conditions
- Type 1 Diabetes in Children
- Keywords
- child, diabetes, animation, education, metabolic, control, self-care
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 6 Oct 2025 (estimated)
- First posted
- 6 Aug 2025 (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.
The aim of this study is to evaluate the attitude towards the disease, perceived social support systems, metabolic control and self-care ability of pediatric patients diagnosed with Type 1 diabetes, by giving video animation training considering their age and developmental level. The main questions it aims to answer are:
- Nursing interventions using video animations increase self-care abilities in children aged 11-18.
- Nursing interventions using video animations increase the perception of social support in children aged 11-18.
- Nursing interventions using video animations support metabolic control in children aged 11-18.
- Nursing interventions using video animations positively affect the attitudes of children aged 11-18 toward their illness.
Detailed description
With the development and proliferation of technology, an essential part of our daily lives, adaptation and developments in technology have begun to increase in the healthcare sector. Research has shown that games and video animations are effective methods beyond medication. No studies have been found in the literature evaluating the effects of diabetes education provided through video animation on the metabolic control, self-care abilities, and attitudes toward the disease in children with Type 1 diabetes. Therefore, the aim of this study is to evaluate the effects of video animation education given to children diagnosed with Type 1 diabetes on their attitudes toward the disease, perception of social support, and self-care abilities. It is anticipated that this research will provide a proactive, multifaceted approach to care and treatment. The study was designed as a pretest/posttest randomized controlled trial. The study population consisted of children aged 11-18 who were regularly followed in the outpatient clinic and had been diagnosed with Type 1 diabetes for at least 6 months. Children who accepted the study and met the criteria were assigned to the video animation and control groups using a block randomization method. The study sample was determined to be 80 individuals, 40 in the experimental group and 40 in the control group. The video animation scenario to be used in the study was created by the researchers in parallel with the routine diabetes education provided at the hospital, and expert approval was obtained. The video animation scenes were prepared by a voice actor and illustrator as part of the project. The experimental group will receive diabetes education through video animation following the routine diabetes education provided by the hospital. Pre- and post-intervention surveys will be administered. The control group will receive routine diabetes education from the hospital's diabetes nurse. No other intervention will be administered. Pre-tests/post-tests and surveys will be administered before and after the diabetes education.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups, the traditional experimental and control groups
| Arm | Type | Receives |
|---|---|---|
| The experimental group will receive diabetes education through video animation. | Active comparator | Other: Diabetes education with video animationFollowing the routine diabetes education provided by the hospital, the experimental group will receive diabetes education using a video animation prepared by the researcher and approved by an expert. Pre- and post-intervention surveys will be administered. |
| Control group to receive routine diabetes education | No intervention | –The control group will receive routine diabetes education from the hospital's diabetes nurse. No intervention will be applied. Only the scale and pre-test/post-test will be administered to the control groups. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Agreeing to participate in the study
- Diagnosed with Type 1 DM by a specialist
- Diagnosed with Type 1 diabetes for at least 6 months
- Being between the ages of 11 and 18
- Using an insulin pen
Key exclusion criteria (3 listed)
- Using an insulin pump
- Not being mentally healthy
- Having any mental or physical disability
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 |
|---|---|---|
| Diabetes education with video animationProviding diabetes education to the experimental group through a video animation Following the routine diabetes education provided by the hospital, the experimental group will receive diabetes education using a video animation prepared and staged by the researcher and approved by experts. | Other | The experimental group will receive diabetes education through video animation. |
Primary outcome
Metabolic Control
Time frame: three weeks
Weight and height measurements will be combined to report body mass index in kg/m². Fasting and postprandial blood glucose values and HbA1C values will be evaluated.
Self-care power
Time frame: three weeks
The five-point Likert-type self-care agency scale, which offers an opportunity for self-assessment, consists of 35 questions. The total score obtained from the scale ranges from 35 to 140. A higher total score indicates that the patient is more independent and competent in self-care.
Attitude Towards One's Own Illness
Time frame: three weeks
It provides an opportunity to assess the attitudes children with chronic illness develop toward their illness. A 13-item, five-point Likert-type scale was designed to self-report children with chronic illnesses. Four of the 13 items are bipolar (very good, somewhat good, not sure, somewhat bad, very bad), while nine items assess how often children experience positive or negative feelings specific to having a chronic illness, using the phrases "very often, often, sometimes, not often, never." Mean scores for items measuring children's attitudes toward their illnesses range from 1 to 5. The lowest possible total score is 13, and the highest is 65. There are no reverse items. Scores of 1 and 2 indicate a negative attitude, 3 indicate a neutral attitude, and 4 and 5 indicate a positive attitude. The internal consistency coefficient of the scale was determined to be 0.79.
Multifaceted Perceived Social Support
Time frame: three weeks
The total score available ranges from 12 to 84. A higher score indicates a positive perception of social support.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Gamze Nur YILMAZ, PhD principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes education with video animation in people with Type 1 Diabetes in Children, run by Ataturk University at 1 site 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 8 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Metabolic Control (time frame: three weeks). The study lists 4 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 6 Aug 2025.