Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418269
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-13
Brief Title:
The Effect of Therapeutic Play on Anxiety and Fear Levels in Children With Diabetes
Sponsor:
Istanbul University - Cerrahpasa IUC
Organization:
Istanbul University - Cerrahpasa IUC
Study Overview
Official Title:
The Effect of Insulin Education Given to Children With Diabetes by Therapeutic Play Method on Anxiety and Fear Levels
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 childrens 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 childs 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 childs 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
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 childs 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 childs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None