The Effect of Therapeutic Play on Anxiety and Fear Levels in Children With Diabetes
The Effect of Insulin Education Given to Children With Diabetes by Therapeutic Play Method on Anxiety and Fear Levels
1 other identifier
interventional
60
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2024
CompletedFirst Posted
Study publicly available on registry
May 17, 2024
CompletedStudy Start
First participant enrolled
July 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 18, 2026
April 30, 2025
January 1, 2025
11 months
May 13, 2024
April 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
Therapeutic Play Group
EXPERIMENTALControl Group
NO INTERVENTIONInterventions
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".
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Visual, hearing or speech impairment
- Illiteracy of the child
- Having a clinical condition that prevents playing games (excessive fatigue, weakness, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
May 13, 2024
First Posted
May 17, 2024
Study Start
July 18, 2025
Primary Completion (Estimated)
June 18, 2026
Study Completion (Estimated)
August 18, 2026
Last Updated
April 30, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share