The Effect Of Color Rotation Technique Training On İnsülin Self-management İn Diabetic Patients.

NCT07501988 | Not Yet Recruiting

• 1 other identifier: GaziosmanpasaU-hemsirelik-mş01
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

Diabetes mellitus (DM) is a chronic disease characterized by impaired carbohydrate, protein, and lipid metabolism, resulting from a deficiency of insulin hormone secreted by the pancreas and/or the body's inability to utilize it even when sufficient insulin is secreted. As a frequently observed chronic disease, diabetes is a significant public health problem; if left uncontrolled, it can lead to serious complications and negatively impact quality of life.Individual management of treatment is crucial for successful treatment and glycemic control in diabetes. Due to the complexity of diabetes management related to insulin use, diabetics require greater self-care skills. Nurses play a crucial role in developing desired self-management behaviors in individuals with diabetes, supporting them, and meeting their needs.

Conditions

Diabete Mellitus; İnsulin Self-management

Keywords

Diabete Mellitus; İnsulin self-management; Nurse

Outcome Measures

Primary Outcomes (1)

• Insulin therapy self-management scale

  The Insulin Therapy Self-Management Scale is a tool used to assess the knowledge and skill levels, as well as positive and negative attitudes, of individuals with diabetes regarding insulin therapy.The Insulin Therapy Self-Management Scale is a scale used to assess the knowledge and skill levels and positive and negative attitudes of individuals with diabetes regarding insulin therapy. This scale was developed in 2019 by Karahan Okuroğlu and colleagues. The scale consists of 32 items with a three-factor structure, scored using a five-point Likert scale. The behavioral subscale comprises 17 items scoring between 17 and 85. The cognitive subscale comprises 7 items scoring between 7 and 35. The affective subscale comprises 8 items scoring between 8 and 40. Items in the affective subscale, and the item "I do not inject insulin myself," are analyzed using reverse coding due to their negative connotations. An increase in scores across all subscales indicates an increase in self-management l

  twelve weeks

Study Arms (2)

Education

EXPERIMENTAL

Patients will be informed about the importance of rotation and needle tip changes in diabetes management, and will receive training on injection technique, rotation technique, frequency of rotation, and the importance of needle tip changes using a mannequin. Patients will be reminded of the rotation plan and changes with each injection, and rotation training will be provided using a chart with visually colored rotation zones and written markings. Each patient consultation will last approximately 30-45 minutes. Patients will be given an educational booklet prepared with expert opinion. Communication with patients will be clear and understandable. Patients' questions will be answered after the training.

Behavioral: Education

CONTROL

NO INTERVENTION

Patients will be asked to perform injections using the mannequin as they routinely do. The mannequin to be used for the demonstration will be obtained from the unit where the research is being conducted. Any knowledge and skill gaps in patients regarding diabetes and insulin injections will be identified. No intervention will be performed on patients in the control group. Control group patients will also be given the prepared diabetes education booklet, considering their ethical right to be informed.

Interventions

Education BEHAVIORAL

Patients will be informed about the importance of rotation and needle tip changes in diabetes management, and will receive training on injection technique, rotation technique, frequency of rotation, and the importance of needle tip changes using a mannequin. Patients will be reminded of the rotation plan and changes with each injection, and rotation training will be provided using a chart with visually colored rotation zones and written markings. Each patient consultation will last approximately 30-45 minutes. Patients will be given an educational booklet prepared with expert opinion. Communication with patients will be clear and understandable. Patients' questions will be answered after the training.

Education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18-65
• At least a primary school graduate
• Diagnosed with Type 1 or Type 2 Diabetes for at least six months
• Receiving insulin treatment
• Capable of self-administering insulin injections
• Free from psychiatric illness or communication impairment (vision, hearing, and speech)
• Able to use a mobile phone and send and receive SMS messages
• Administering insulin injections 4 times a day
• Individuals who agree to participate in the study

You may not qualify if:

• Not using insulin treatment-Using an insulin pump
• Having temporary insulin treatment
• Having lipodystrophy-Individuals who refused to participate in the study or who discontinued their education

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead
• Ataturk University: collaborator

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Merve Ayşe Şahin

  TOKAT GAZİOSMANPAŞA UNİVERSITY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merve Ayşe Şahin

CONTACT

+905437961677; keskin_merve@hotmail.com

Prof. Dr. Mehtap KAVURMACI, PROF. DR.

CONTACT

+90 442 231 3554; mehtap.kavurmaci@atauni.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participate will not know,which group they are in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor investigater

Model Details: Randomize Control

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: March 30, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): July 22, 2026
• Study Completion (Estimated): July 22, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR