Type1diabetesNCT06418269
The Effect of Therapeutic Play on Anxiety and Fear Levels in Children With Diabetes
A study testing Therapeutic Play in people with Type1diabetes and Therapeutic Play, run by Istanbul University - Cerrahpasa.
Trial summary
The study will be conducted using a randomized controlled method. Children with type 1 diabetes who are admitted to the Pediatric Endocrinology Service will be divided into two groups by randomization method. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Type1diabetes, Therapeutic Play, Fear State
- What is being tested?
- Therapeutic Play
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 18 Jul 2025to 18 Aug 2026
- 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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The child must be between the ages of 9 and 12 (since the State Anxiety Inventory for Children Scale is for this age range)
- Diagnosed with type 1 diabetes
- Absence of mental retardation
- Receiving subcutaneous insulin treatment for the first time
- Voluntariness of the child and parent to participate in the study
Who cannot join
- Visual, hearing or speech impairment
- Illiteracy of the child
- Having a clinical condition that prevents playing games (excessive fatigue, weakness, etc.)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Nermin Eroğlu, PhD contact
About this study
Official title: The Effect of Insulin Education Given to Children With Diabetes by Therapeutic Play Method on Anxiety and Fear Levels
The study will be conducted using a randomized controlled method. Children with type 1 diabetes who are admitted to the Pediatric Endocrinology Service will be divided into two groups by randomization method. Following randomization, children in the experimental group will play a therapeutic game before their subcutaneous insulin treatment. In the subcutaneous insulin treatment of the children in the control group, the routine practice of the clinic will be applied. Anxiety and fear levels of all children in the experimental and control groups will be evaluated before and after subcutaneous insulin treatment.
Read the detailed description
Excessive stress and anxiety experienced by children can affect their physical and physiological health and hinder their ability to cope with medical interventions. Pain and negative emotions associated with blood sampling or insulin administration can negatively affect children's diabetes self-care skills and may lead to avoidance of injections.
Play-based interventions allow the child to process potentially frightening events and correct misconceptions about an illness and its management. Overall, therapeutic play interventions have been effective in reducing the child's pain, anxiety and stress while encouraging cooperation. Since insulin treatment (subcutaneous) causes fear and anxiety in children, the aim of this study was to reduce fear and anxiety by dramatization method by storytelling the child's procedure and disease with the game of administering insulin treatment (subcutaneous) to a doll.
In the Pediatric Endocrinology Service, children between the ages of 9 and 12 years who have just been diagnosed with Type 1 diabetes and who meet the sample selection criteria and their parents will be met and informed about the study and written and verbal consent will be obtained from the children and their parents who volunteer to participate in the study. Children will be asked to fill out the "Child Patient Identification Form", "State Anxiety Scale in Children" and "Child Fear Scale" 30 minutes before insulin treatment. Then, the children will be randomized by the researcher and assigned to two different groups as experimental and control groups. Before the insulin treatment procedure, the children in the experimental group will be made to take blood glucose and administer insulin on a doll with the therapeutic play method. The children in the control group will receive the routine treatment of the clinic. Within 10 minutes after subcutaneous insulin treatment, the child will be asked to fill out the "State Anxiety Scale in Children" and "Child Fear Scale".
Therapeutic Play Content: The doll to be used in the study represents the sick children in the experimental group. The child will be told that the doll has been hospitalized with a diagnosis of Type 1 diabetes and will be expected to assume the role of a nurse in order to administer insulin to the doll. The materials to be used during insulin administration will be introduced to the child and the child will be made to recognize the materials more closely. Then, the steps of blood glucose measurement and insulin treatment (subcutaneous) will be explained to the child and the child will be asked to apply the insulin to the doll.
- Conditions
- Type1diabetes, Therapeutic Play, Fear State, Anxiety State
- Being tested
- Therapeutic Play
- Keywords
- Type1diabetes, Therapeutic play, Fear state, Anxiety State
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic PlayOther
Children will be asked to fill in the "Child Patient Identification Form", "State Anxiety Scale in Children" and "Child Fear Scale" 30 minutes before insulin treatment. Before the insulin treatment, the children in the experimental group will have their blood glucose measured and insulin administered on a doll using the therapeutic play method. The child will be told that the doll is hospitalized with a diagnosis of Type 1 diabetes and will be expected to assume the role of a nurse to administer insulin to the doll. Then, the steps of blood glucose measurement and insulin treatment (subcutaneous) will be explained to the child and the child will be asked to administer insulin to the baby. Within 10 minutes after subcutaneous insulin treatment, the child will be asked to fill out the "State Anxiety Scale in Children" and "Child Fear Scale".
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Play Group | Experimental | Not described Receives: Other: Therapeutic Play |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory for Children
Anxiety states of children that may occur due to subcutaneous insulin treatment will be evaluated. The lowest score that can be obtained from the State Anxiety Scale is 20 and the highest score is 60.
Measured: 30 minutes before insulin treatment, within 10 minutes after subcutaneous insulin treatment
Child Fear Scale
Fear states of children that may occur due to subcutaneous insulin treatment will be evaluated. In this method, the child is shown a picture with five facial expressions rated between 0 and 4. 0 indicates no fear and anxiety, while 4 indicates the highest fear and anxiety.
Measured: 30 minutes before insulin treatment, within 10 minutes after subcutaneous insulin treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start18 Jul 2025 (estimated)
- Primary completion18 Jun 2026 (estimated)
- Study completion18 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Canan Genç, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418269
- Sponsor's protocol ID
- 53.2024fbu
- Status last verified
- Jan 2025
- First submitted
- 13 May 2024
- Last updated
- 30 Apr 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 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Insulin Education Given to Children With Diabetes by Therapeutic Play Method on Anxiety and Fear Levels
- ClinicalTrials.gov ID
- NCT06418269
- Acronym / sponsor ID
- 53.2024fbu
- Conditions
- Type1diabetes, Therapeutic Play, Fear State, Anxiety State
- Keywords
- Type1diabetes, Therapeutic play, Fear state, Anxiety State
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 18 Jul 2025 (estimated)
- Primary completion
- 18 Jun 2026 (estimated)
- Study completion
- 18 Aug 2026 (estimated)
- First posted
- 17 May 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.
The study will be conducted using a randomized controlled method. Children with type 1 diabetes who are admitted to the Pediatric Endocrinology Service will be divided into two groups by randomization method. Following randomization, children in the experimental group will play a therapeutic game before their subcutaneous insulin treatment. In the subcutaneous insulin treatment of the children in the control group, the routine practice of the clinic will be applied. Anxiety and fear levels of all children in the experimental and control groups will be evaluated before and after subcutaneous insulin treatment.
Detailed description
Excessive stress and anxiety experienced by children can affect their physical and physiological health and hinder their ability to cope with medical interventions. Pain and negative emotions associated with blood sampling or insulin administration can negatively affect children's diabetes self-care skills and may lead to avoidance of injections.
Play-based interventions allow the child to process potentially frightening events and correct misconceptions about an illness and its management. Overall, therapeutic play interventions have been effective in reducing the child's pain, anxiety and stress while encouraging cooperation. Since insulin treatment (subcutaneous) causes fear and anxiety in children, the aim of this study was to reduce fear and anxiety by dramatization method by storytelling the child's procedure and disease with the game of administering insulin treatment (subcutaneous) to a doll.
In the Pediatric Endocrinology Service, children between the ages of 9 and 12 years who have just been diagnosed with Type 1 diabetes and who meet the sample selection criteria and their parents will be met and informed about the study and written and verbal consent will be obtained from the children and their parents who volunteer to participate in the study. Children will be asked to fill out the "Child Patient Identification Form", "State Anxiety Scale in Children" and "Child Fear Scale" 30 minutes before insulin treatment. Then, the children will be randomized by the researcher and assigned to two different groups as experimental and control groups. Before the insulin treatment procedure, the children in the experimental group will be made to take blood glucose and administer insulin on a doll with the therapeutic play method. The children in the control group will receive the routine treatment of the clinic. Within 10 minutes after subcutaneous insulin treatment, the child will be asked to fill out the "State Anxiety Scale in Children" and "Child Fear Scale".
Therapeutic Play Content: The doll to be used in the study represents the sick children in the experimental group. The child will be told that the doll has been hospitalized with a diagnosis of Type 1 diabetes and will be expected to assume the role of a nurse in order to administer insulin to the doll. The materials to be used during insulin administration will be introduced to the child and the child will be made to recognize the materials more closely. Then, the steps of blood glucose measurement and insulin treatment (subcutaneous) will be explained to the child and the child will be asked to apply the insulin to the doll.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Play Group | Experimental | Other: Therapeutic Play |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The child must be between the ages of 9 and 12 (since the State Anxiety Inventory for Children Scale is for this age range)
- Diagnosed with type 1 diabetes
- Absence of mental retardation
- Receiving subcutaneous insulin treatment for the first time
- Voluntariness of the child and parent to participate in the study
Key exclusion criteria (3 listed)
- Visual, hearing or speech impairment
- Illiteracy of the child
- Having a clinical condition that prevents playing games (excessive fatigue, weakness, etc.)
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 |
|---|---|---|
| Therapeutic PlayChildren will be asked to fill in the "Child Patient Identification Form", "State Anxiety Scale in Children" and "Child Fear Scale" 30 minutes before insulin treatment. Before the insulin treatment, the children in the experimental group will have their blood glucose measured and insulin administered on a doll using the therapeutic play method. The child will be told that the doll is hospitalized with a diagnosis of Type 1 diabetes and will be expected to assume the role of a nurse to administer insulin to the doll. Then, the steps of blood glucose measurement and insulin treatment (subcutaneous) will be explained to the child and the child will be asked to administer insulin to the baby. Within 10 minutes after subcutaneous insulin treatment, the child will be asked to fill out the "State Anxiety Scale in Children" and "Child Fear Scale". | Other | Therapeutic Play Group |
Primary outcome
State-Trait Anxiety Inventory for Children
Time frame: 30 minutes before insulin treatment, within 10 minutes after subcutaneous insulin treatment
Anxiety states of children that may occur due to subcutaneous insulin treatment will be evaluated. The lowest score that can be obtained from the State Anxiety Scale is 20 and the highest score is 60.
Child Fear Scale
Time frame: 30 minutes before insulin treatment, within 10 minutes after subcutaneous insulin treatment
Fear states of children that may occur due to subcutaneous insulin treatment will be evaluated. In this method, the child is shown a picture with five facial expressions rated between 0 and 4. 0 indicates no fear and anxiety, while 4 indicates the highest fear and anxiety.
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 30 Apr 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.
Nermin Eroğlu, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Play in people with Type1diabetes and Therapeutic Play, run by Istanbul University - Cerrahpasa.
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 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: opening soon, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Canan Genç, MSc (5372828808, cananuzun5561@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory for Children (time frame: 30 minutes before insulin treatment, within 10 minutes after subcutaneous insulin treatment). The study lists 2 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 30 Apr 2025.