## Protocol Section
### Identification Module
**NCT ID:** NCT06418269

**Brief Title:** The Effect of Therapeutic Play on Anxiety and Fear Levels in Children With Diabetes

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

#### Organization Study ID Info
**ID:** 53.2024fbu
#### Organization
**Class:** OTHER
**Full Name:** Istanbul University - Cerrahpasa (IUC)
### Status Module
#### Completion Date
**Date:** 2025-08-18

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-18

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09-18

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Istanbul University - Cerrahpasa (IUC)

#### Responsible Party

**Investigator Affiliation:** Fenerbahce University

**Investigator Full Name:** Canan Genç

**Investigator Title:** Research Assistant

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 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.

### Conditions Module

**Conditions:**

- Type1diabetes

- Therapeutic Play

- Fear State

- Anxiety State

**Keywords:**

- Type1diabetes

- Therapeutic play

- Fear state

- Anxiety State

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Therapeutic Play

**Label:** Therapeutic Play Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Label:** Control Group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Therapeutic Play Group

**Description:** 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".

**Name:** Therapeutic Play

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** State-Trait Anxiety Inventory for Children

**Time Frame:** 30 minutes before insulin treatment, within 10 minutes after subcutaneous insulin treatment

**Description:** 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.

**Measure:** Child Fear Scale

**Time Frame:** 30 minutes before insulin treatment, within 10 minutes after subcutaneous insulin treatment

### Eligibility Module

**Eligibility Criteria:** 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.)

**Healthy Volunteers:** True

**Maximum Age:** 12 Years

**Minimum Age:** 9 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** cananuzun5561@gmail.com

**Name:** Canan Genç, MSc

**Phone:** 5372828808

**Role:** CONTACT

**Contact 2:**

**Email:** nermin.guduloglu20@gmail.com

**Name:** Nermin Eroğlu, PhD

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000001523

- Term: Mental Disorders

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M7117

- Name: Diabetes Mellitus, Type 1

- Relevance: HIGH

- As Found: Type 1 Diabetes

- ID: M4324

- Name: Anxiety Disorders

- Relevance: HIGH

- As Found: Anxiety

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003922

- Term: Diabetes Mellitus, Type 1

- ID: D000001008

- Term: Anxiety Disorders

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10365

- Name: Insulin

- Relevance: LOW

- As Found: Unknown

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
