NCT07107789

Brief Summary

The aim of this study is to evaluate the attitude towards the disease, perceived social support systems, metabolic control and self-care ability of pediatric patients diagnosed with Type 1 diabetes, by giving video animation training considering their age and developmental level. The main questions it aims to answer are:

  1. 1.Nursing interventions using video animations increase self-care abilities in children aged 11-18.
  2. 2.Nursing interventions using video animations increase the perception of social support in children aged 11-18.
  3. 3.Nursing interventions using video animations support metabolic control in children aged 11-18.
  4. 4.Nursing interventions using video animations positively affect the attitudes of children aged 11-18 toward their illness.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

August 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2025

Completed
Last Updated

August 6, 2025

Status Verified

July 1, 2025

Enrollment Period

1 month

First QC Date

July 11, 2025

Last Update Submit

August 4, 2025

Conditions

Keywords

childdiabetesanimationeducationmetaboliccontrolself-care

Outcome Measures

Primary Outcomes (4)

  • Metabolic Control

    Weight and height measurements will be combined to report body mass index in kg/m². Fasting and postprandial blood glucose values and HbA1C values will be evaluated.

    three weeks

  • Self-care power

    The five-point Likert-type self-care agency scale, which offers an opportunity for self-assessment, consists of 35 questions. The total score obtained from the scale ranges from 35 to 140. A higher total score indicates that the patient is more independent and competent in self-care.

    three weeks

  • Attitude Towards One's Own Illness

    It provides an opportunity to assess the attitudes children with chronic illness develop toward their illness. A 13-item, five-point Likert-type scale was designed to self-report children with chronic illnesses. Four of the 13 items are bipolar (very good, somewhat good, not sure, somewhat bad, very bad), while nine items assess how often children experience positive or negative feelings specific to having a chronic illness, using the phrases "very often, often, sometimes, not often, never." Mean scores for items measuring children's attitudes toward their illnesses range from 1 to 5. The lowest possible total score is 13, and the highest is 65. There are no reverse items. Scores of 1 and 2 indicate a negative attitude, 3 indicate a neutral attitude, and 4 and 5 indicate a positive attitude. The internal consistency coefficient of the scale was determined to be 0.79.

    three weeks

  • Multifaceted Perceived Social Support

    The total score available ranges from 12 to 84. A higher score indicates a positive perception of social support.

    three weeks

Study Arms (2)

The experimental group will receive diabetes education through video animation.

ACTIVE COMPARATOR

Following the routine diabetes education provided by the hospital, the experimental group will receive diabetes education using a video animation prepared by the researcher and approved by an expert. Pre- and post-intervention surveys will be administered.

Other: Diabetes education with video animation

Control group to receive routine diabetes education

NO INTERVENTION

The control group will receive routine diabetes education from the hospital's diabetes nurse. No intervention will be applied. Only the scale and pre-test/post-test will be administered to the control groups.

Interventions

Providing diabetes education to the experimental group through a video animation Following the routine diabetes education provided by the hospital, the experimental group will receive diabetes education using a video animation prepared and staged by the researcher and approved by experts.

The experimental group will receive diabetes education through video animation.

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Agreeing to participate in the study
  • Diagnosed with Type 1 DM by a specialist
  • Diagnosed with Type 1 diabetes for at least 6 months
  • Being between the ages of 11 and 18
  • Using an insulin pen
  • Not using an insulin pump
  • Coming for regular checkups at the Pediatric Endocrinology clinic
  • Having no other chronic disease besides diabetes

You may not qualify if:

  • Using an insulin pump
  • Not being mentally healthy
  • Having any mental or physical disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzurum City Hospital

Erzurum, Palandöken, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Gamze Nur YILMAZ, PhD

    Ataturk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The control group will receive routine diabetes education from the hospital's diabetes nurse. The experimental group will receive diabetes education using a video animation prepared by the researcher following the routine diabetes education provided by the diabetes nurse. The outcome assessment and group allocation will be conducted by a researcher who is unaware of the outcome.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two groups, the traditional experimental and control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd Student

Study Record Dates

First Submitted

July 11, 2025

First Posted

August 6, 2025

Study Start

August 15, 2025

Primary Completion

September 15, 2025

Study Completion

October 6, 2025

Last Updated

August 6, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations