The Effect of Therapeutic Play on Anxiety and Fear Levels in Children With Diabetes

Type1diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06418269
• Other study ID #: 53.2024fbu
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 18, 2024
• Est. completion date: August 18, 2025

Study information

• Verified date: May 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Canan Genç, MSc
• Phone: 5372828808
• Email: cananuzun5561[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• 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.)

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

Other:
• Therapeutic Play
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".

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Outcome

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