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临床试验/NCT06418269
NCT06418269尚未招募不适用

The Effect of Insulin Education Given to Children With Diabetes by Therapeutic Play Method on Anxiety and Fear Levels

Istanbul University - Cerrahpasa0 个研究点目标入组 60 人开始时间: 2025年7月18日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
主要终点
State-Trait Anxiety Inventory for Children

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
9 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Visual, hearing or speech impairment
  • Illiteracy of the child
  • Having a clinical condition that prevents playing games (excessive fatigue, weakness, etc.)

结局指标

主要结局

State-Trait Anxiety Inventory for Children

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Canan Genç

Research Assistant

Fenerbahce University

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