Type 1 Diabetes MellitusNCT05649553
The Effect of Diabetes Education Digital Games and Video Animation on Quality of Life
A study testing digital game and video animation based diabetes education in people with Type 1 Diabetes Mellitus, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
This research will be conducted to evaluate the effect of digital game and video animation-based diabetes education on the quality of life of children with Type 1 Diabetes. HbA1c, diabetes knowledge and Quality of Life Scale in Children with Diabetes (PedsQL 3.0) score will be taken into consideration when evaluating… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- digital game and video animation based diabetes education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2022to 15 Sep 2023
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children's willingness to participate in the research (written consent of their parents, verbal consent was obtained from the children),
- Being between the ages of 8-12,
- Having been diagnosed with Type 1 Diabetes Mellitus at least 1 year ago
- To have regular follow-ups,
- No communication disability (speech, hearing, vision problems)
- It means having a device (computer) with internet connection at home and being able to use it.
Who cannot join
- Having any chronic disease together with diabetes,
- Using an insulin pump
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Diabetes Education Given to Children With Type 1 Diabetes Mellitus With Digital Games and Video Animation on Quality of Life
This research will be conducted to evaluate the effect of digital game and video animation-based diabetes education on the quality of life of children with Type 1 Diabetes. HbA1c, diabetes knowledge and Quality of Life Scale in Children with Diabetes (PedsQL 3.0) score will be taken into consideration when evaluating the quality of life of children with type 1 diabetes.
Read the detailed description
This research was conducted to examine the effects of diabetes education given to children with Type 1 Diabetes Mellitus with digital game and video animation on quality of life and metabolic control. The study is a single-blind, randomized controlled trial. It was conducted with a total of 55 children with Type 1 Diabetes Mellitus, including the experimental (n=27) and control group (n=28). Diabetes education was given to the experimental group with digital games and video animations. Data were collected before the training, at the 3rd and 6th months after the training. Research data were collected with "Descriptive Information Form", "Quality of Life Scale in Children with Diabetes Mellitus" and "Metabolic Control Parameters Follow-up Form". Children in the control group received routine outpatient examination/check-up and diabetes education by a diabetes nurse. Children in the intervention group were given digital game and video animation-based training, as well as routine outpatient examination/check-up and training given by a diabetes nurse.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- digital game and video animation based diabetes education
- Keywords
- diabetes education, digital game, video animation
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital game and video animation based diabetes educationBehavioural
Also called digital game, video animation
While creating the digital game and video animation, an agreement was made with a software company and this company was responsible for the software and repair of the game. Digital games and video animations cover the basic educational topics of Type 1 diabetes. Expert opinions were received from experts in the field of Child Health and Disease Nursing to ensure the suitability of the content of the educational material. The name of the game site and how to use it were explained to the children in the intervention group by the researcher. In addition, children in the intervention group were given usernames and passwords to log in to the site. Game Sections; What is Diabetes? Medical Nutrition Treatment in Diabetes, Insulin Treatment and Application, Exercise and Physical Activity in Diabetes, Complications of Type 1 Diabetes Mellitus, Diabetes Management at School.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Experimental: Intervention Group Application of the Introductory Information Form and the "Quality of Life Scale in Children with Diabetes Mellitus (PedsQL 3.0 Diabetes Scale)" test Giving digital game and video animation-based diabetes education to the children in the experimental group, in addition to the education given by the diabetes nurse, Applying the first post-training follow-up test to children in the experimental and control groups 3 months after the training.
Applying the post-training-2nd follow-up test to the children in the experimental and control groups 6 months after the training. Receives: Behavioral: digital game and video animation based diabetes education |
| Control Group | No intervention | The control group received routine nursing care in the endocrine policlinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Measuring the changes in HbA1c levels of children with type 1 diabetes before training and at the 3rd and 6th months after training.
Measured: Baseline, 3. and 6. months
Secondary outcomes (1)
Changes in quality of life
Measuring the changes in quality of life of children with type 1 diabetes before training and at the 3rd and 6th months after training.
Measured: Baseline, 3. and 6. months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start15 Sep 2022
- Primary completion15 May 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- This study is a parallel group randomized controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Tınmaz Pehlivan, Pamukkale University
- Investigators
- Sebahat ALTUNDAĞ, AssocProfDr., Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649553
- Sponsor's protocol ID
- GPehlivan
- Other IDs
- Sebahat ALTUNDAĞ, Assoc. Prof.
- Status last verified
- Nov 2024
- First submitted
- 6 Dec 2022
- Last updated
- 13 Nov 2024
- 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 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diabetes Education Given to Children With Type 1 Diabetes Mellitus With Digital Games and Video Animation on Quality of Life
- ClinicalTrials.gov ID
- NCT05649553
- Acronym / sponsor ID
- GPehlivan
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- diabetes education, digital game, video animation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 14 Dec 2022 (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 research will be conducted to evaluate the effect of digital game and video animation-based diabetes education on the quality of life of children with Type 1 Diabetes. HbA1c, diabetes knowledge and Quality of Life Scale in Children with Diabetes (PedsQL 3.0) score will be taken into consideration when evaluating the quality of life of children with type 1 diabetes.
Detailed description
This research was conducted to examine the effects of diabetes education given to children with Type 1 Diabetes Mellitus with digital game and video animation on quality of life and metabolic control. The study is a single-blind, randomized controlled trial. It was conducted with a total of 55 children with Type 1 Diabetes Mellitus, including the experimental (n=27) and control group (n=28). Diabetes education was given to the experimental group with digital games and video animations. Data were collected before the training, at the 3rd and 6th months after the training. Research data were collected with "Descriptive Information Form", "Quality of Life Scale in Children with Diabetes Mellitus" and "Metabolic Control Parameters Follow-up Form". Children in the control group received routine outpatient examination/check-up and diabetes education by a diabetes nurse. Children in the intervention group were given digital game and video animation-based training, as well as routine outpatient examination/check-up and training given by a diabetes nurse.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a parallel group randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: digital game and video animation based diabetes educationExperimental: Intervention Group Application of the Introductory Information Form and the "Quality of Life Scale in Children with Diabetes Mellitus (PedsQL 3.0 Diabetes Scale)" test Giving digital game and video animation-based diabetes education to the children in the experimental group, in addition to the education given by the diabetes nurse, Applying the first post-training follow-up test to children in the experimental and control groups 3 months after the training. Applying the post-training-2nd follow-up test to the children in the experimental and control groups 6 months after the training. |
| Control Group | No intervention | –The control group received routine nursing care in the endocrine policlinic. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children's willingness to participate in the research (written consent of their parents, verbal consent was obtained from the children),
- Being between the ages of 8-12,
- Having been diagnosed with Type 1 Diabetes Mellitus at least 1 year ago
- To have regular follow-ups,
- No communication disability (speech, hearing, vision problems)
Key exclusion criteria (2 listed)
- Having any chronic disease together with diabetes,
- Using an insulin pump
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 |
|---|---|---|
| digital game and video animation based diabetes educationAlso: digital game, video animationWhile creating the digital game and video animation, an agreement was made with a software company and this company was responsible for the software and repair of the game. Digital games and video animations cover the basic educational topics of Type 1 diabetes. Expert opinions were received from experts in the field of Child Health and Disease Nursing to ensure the suitability of the content of the educational material. The name of the game site and how to use it were explained to the children in the intervention group by the researcher. In addition, children in the intervention group were given usernames and passwords to log in to the site. Game Sections; What is Diabetes? Medical Nutrition Treatment in Diabetes, Insulin Treatment and Application, Exercise and Physical Activity in Diabetes, Complications of Type 1 Diabetes Mellitus, Diabetes Management at School. | Behavioural | Intervention Group |
Primary outcome
Change in HbA1c
Time frame: Baseline, 3. and 6. months
Measuring the changes in HbA1c levels of children with type 1 diabetes before training and at the 3rd and 6th months after training.
1 secondary outcome
Changes in quality of life
Time frame: Baseline, 3. and 6. months
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 13 Nov 2024.
- 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. This study is not recruiting at the moment.
Sebahat ALTUNDAĞ, AssocProfDr. study director
Pamukkale 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 digital game and video animation based diabetes education in people with Type 1 Diabetes Mellitus, run by Pamukkale 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 6 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 13 Nov 2024. 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?
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?
Change in HbA1c (time frame: Baseline, 3. and 6. months). 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 13 Nov 2024.