The Effect of Animated Movies and Storybooks on Fear and Anxiety Levels in Children With Type 1 Diabetes

NCT06350513 | Recruiting

• 1 other identifier: NecmettinE
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

Brief Summary

This study aims to evaluate the effects of animated films and story books on the fear and anxiety levels of children with newly diagnosed type 1 diabetes.

Conditions

Diabetes Mellitus, Type 1; Child, Only; Anxiety; Fear; Nurse

Outcome Measures

Primary Outcomes (3)

• State Anxiety Inventory for Children (STAI-C)

  This scale was developed to evaluate children's state and trait anxiety and is in a self-report form. As a result of some procedures, the scale was turned into 2 separate scales containing a total of 40 items (20 state and 20 trait anxiety items). Although the validity and reliability of the scale has been done for children aged 9-12, the scale can be used until the age of 17 because it is difficult for children over the age of 12 to understand the adult anxiety scale. In the State Anxiety Scale for Children, children are asked to mark one of three options regarding how they evaluate how they feel at that moment. The scale aims to evaluate emotions related to state anxiety such as tension, irritability, rush, and uneasiness. The highest score that can be obtained from the State Anxiety Scale is 60 and the lowest score is 20. Cronbach's α value was found to be 0.82

  Initial assessment will be performed at baseline (pre-intervention)

• State Anxiety Inventory for Children (STAI-C)

  This scale was developed to evaluate children's state and trait anxiety and is in a self-report form. As a result of some procedures, the scale was turned into 2 separate scales containing a total of 40 items (20 state and 20 trait anxiety items). Although the validity and reliability of the scale has been done for children aged 9-12, the scale can be used until the age of 17 because it is difficult for children over the age of 12 to understand the adult anxiety scale. In the State Anxiety Scale for Children, children are asked to mark one of three options regarding how they evaluate how they feel at that moment. The scale aims to evaluate emotions related to state anxiety such as tension, irritability, rush, and uneasiness. The highest score that can be obtained from the State Anxiety Scale is 60 and the lowest score is 20. Cronbach's α value was found to be 0.82

  The second evaluation will be made after the first evaluation (after watching the animated movie and reading the story book (approximately 1 hour later)).

• State Anxiety Inventory for Children (STAI-C)

  This scale was developed to evaluate children's state and trait anxiety and is in a self-report form. As a result of some procedures, the scale was turned into 2 separate scales containing a total of 40 items (20 state and 20 trait anxiety items). Although the validity and reliability of the scale has been done for children aged 9-12, the scale can be used until the age of 17 because it is difficult for children over the age of 12 to understand the adult anxiety scale. In the State Anxiety Scale for Children, children are asked to mark one of three options regarding how they evaluate how they feel at that moment. The scale aims to evaluate emotions related to state anxiety such as tension, irritability, rush, and uneasiness. The highest score that can be obtained from the State Anxiety Scale is 60 and the lowest score is 20. Cronbach's α value was found to be 0.82

  The third evaluation will be made approximately 3 days after the second evaluation.

Secondary Outcomes (3)

• Children's Fear Scale

  Initial assessment will be performed at baseline (pre-intervention)

• Children's Fear Scale

  The second evaluation will be made after the first evaluation (after watching the animated movie and reading the story book (approximately 1 hour later)).

• Children's Fear Scale

  The third evaluation will be made approximately 3 days after the second evaluation.

Study Arms (2)

Animation movie, story book

EXPERIMENTAL

Animation movie: For this study, an animated film (Professor bumblebee animation) prepared for newly diagnosed children with type 1 diabetes will be shown in the experimental group. This is an approximately 10 minute film produced by Life for a children's center in New South Wales (DIABETES AUSTRALIA). The animated film will be translated into Turkish and sent to experts (specialists in the field of Children and Diabetes) for expert opinion. It will be shown to children after all permissions have been obtained following expert opinions. This animated movie is a guide to diabetes for children. Additionally, the storybook will be given as a gift for the children in the experimental group to read. Story Book: It is an educational booklet version of the Professor Bumblebee animation translated into Turkish and illustrated. The aim here is to serve as an auxiliary tool for newly diagnosed T1D children to look at later and where they are confused.

Other: Animation movie, story book

control group

OTHER

No applications will be made.

Other: Animation movie, story book

Interventions

Animation movie, story book OTHER

Animation movie: For this study, an animated film (Professor bumblebee animation) prepared for newly diagnosed children with type 1 diabetes will be shown in the experimental group. This is an approximately 10 minute film produced by Life for a children's center in New South Wales (DIABETES AUSTRALIA). The animated film will be translated into Turkish and sent to experts (specialists in the field of Children and Diabetes) for expert opinion. It will be shown to children after all permissions have been obtained following expert opinions. This animated movie is a guide to diabetes for children. Additionally, the storybook will be given as a gift for the children in the experimental group to read. Story Book: It is an educational booklet version of the Professor Bumblebee animation translated into Turkish and illustrated. The aim here is to serve as an auxiliary tool for newly diagnosed T1D children to look at later and where they are confused.

Animation movie, story book; control group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Volunteering to participate in the study,
• Parental approval
• Being between the ages of 7-12,
• Being diagnosed with T1D for the first time,
• Being literate and able to communicate in Turkish

You may not qualify if:

• Having a mental, visual, hearing or communication impairment,
• Having mental and spiritual health problems,

Sponsors & Collaborators

• Selverhan Yurttutan: lead

Study Sites (3)

NecmettinEU

Konya, Meram, 06480, Turkey (Türkiye)

RECRUITING

Semra Köse

Konya, Meram, Turkey (Türkiye)

RECRUITING

Necmettin Erbakan Üniversity

Konya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Anxiety Disorders

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Mental Disorders

Central Study Contacts

Emine GEÇKİL, Prof. Dr.

CONTACT

05066285460; eminegeckil@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: reserch asistant

Model Details: Parallel Group (Experiment-Control) Randomized Controlled Experimental

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: April 5, 2024
• Study Start: February 25, 2024
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): July 25, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

TU (3)