Type1diabetes Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | August 18, 2025 |
Est. primary completion date | June 18, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 9 Years to 12 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Visual, hearing or speech impairment - Illiteracy of the child - Having a clinical condition that prevents playing games (excessive fatigue, weakness, etc.) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Istanbul University - Cerrahpasa (IUC) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 30 minutes before insulin treatment, within 10 minutes after subcutaneous insulin treatment | |
Primary | 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. | 30 minutes before insulin treatment, within 10 minutes after subcutaneous insulin treatment |
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