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

Not Applicable

Recruiting

• Conditions: Child, Only; Diabetes Mellitus, Type 1; Anxiety; Fear; Nurse

• Registration Number: NCT06350513
• Lead Sponsor: Selverhan Yurttutan

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.

Detailed Description

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. In the study, newly diagnosed children in the experimental group will be shown a 10-minute movie and read the educational booklet. Routine care will continue for the control group.

Study Timeline

• Study Start: 2024-02-25
• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-04-01
• Study First Posted: 2024-04-05
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-12
• Last Update Posted: 2025-06-17
• Primary Completion: 2025-10-25
• Study Completion: 2026-07-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
State Anxiety Inventory for Children (STAI-C)	The third evaluation will be made approximately 3 days after the second evaluation.	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

Secondary Outcome Measures

Name	Time	Method
Children's Fear Scale	The third evaluation will be made approximately 3 days after the second evaluation.	The child fear scale was developed by McMurtry et al. in 2011. The Turkish validity of the scale was determined by Gerçeker et al. It was made by in 2018. The child fear scale was designed to measure a child's anxiety level and is intended to be used in children between the ages of 5-10. However, some suggest that it can also be used in children up to the age of 12. The child is shown five facial expressions (ranging from zero to four), each representing a level on the scale. Zero and four; Zero indicates no fear or anxiety, and four indicates high levels of fear and anxiety. This scale can be used to measure fear and anxiety before and during the procedure. Cohen's Kappa coefficient was checked to determine interobserver agreement.

Trial Locations

Locations (3)

NecmettinEU; 🇹🇷 Konya, Meram, Turkey

Semra Köse; 🇹🇷 Konya, Meram, Turkey

Necmettin Erbakan Üniversity; 🇹🇷 Konya, Turkey