NCT07501988

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Tokat Gaziosmanpasa University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Diabetes mellitus (DM) is a chronic disease resulting from a deficiency of insulin hormone secreted from the pancreas and/or the body's inability to utilize it even when secreted sufficiently; it is characterized by impaired carbohydrate, protein, and lipid metabolism. Diabetes, a frequently observed chronic disease, is a significant public health problem and, if left uncontrolled, can cause serious complications and negatively affect quality of life. Globally, diabetes is increasing; in 2017, the global prevalence among adults was 8.8% of the world's population, and this rate is expected to rise to 9.9% by 2045. Looking at the total figures, it is estimated that there were 424.9 million diabetes patients worldwide in 2017, and this number will reach 628.6 million by 2045, representing a 48% increase. According to the International Diabetes Federation (IDF), there are 463 million people with diabetes worldwide aged 20-79, and this figure is projected to reach 700 million by 2045. to the International Diabetes Federation's 2021 report, there are more than 9 million diabetes patients aged 20-79 in Turkey, with a prevalence of 15.9% in adults. It is estimated that approximately 6.7 million adults aged 20-79 will die from diabetes or related complications in 2021. The prevalence of diabetes is increasing in low- and middle-income countries, and Turkey is one of these countries. 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. Diabetics need to be knowledgeable about insulin types and characteristics, administering injections with the correct technique, dose, and timing, knowing the injection sites, and understanding the rate of insulin absorption and the factors affecting it. Furthermore, for successful insulin management, individuals with diabetes need to be knowledgeable about insulin absorption, insulin storage conditions, managing insulin complications, and adjusting insulin doses according to food intake, and exhibit the right attitudes. Optimal glycemic control plays a key role in preventing diabetes-related complications. The most important aspects of achieving glycemic control in diabetes are medication adherence and blood glucose monitoring . Nurses are responsible for providing the necessary education to individuals with diabetes and their families to prevent diabetes-related complications. The aim of this study is to improve insulin self-management by providing patients with training in the rotation technique. UNIQUE VALUE AND WIDESPREAD IMPACT Diabetes mellitus is a significant and increasingly prevalent health problem among chronic diseases. The most important aspect in the prevention, control, and treatment of diabetes is diabetes education. Diabetes education is a process that includes many components, such as lifestyle changes including diet and exercise, as well as medication and insulin therapy. The most important part of the correct management of diabetes is complete and accurate education. In diabetic patients receiving insulin therapy, teaching them the correct insulin administration skills is the most important part of diabetes management. Correct and complete insulin administration skill training can only be given to the patient with the right education. In the literature, education given to diabetic patients to examine its effect on diabetes management has been planned holistically as diet, exercise, and medication therapy, but there is no education given to diabetic patients only on insulin therapy, on the correct and effective application of insulin. This study will fill the gap in the literature by providing education for the correct and effective application of insulin therapy. It is believed that rotation technique training given to diabetic patients will play an effective role in improving insulin self-management. Diabetic patients receiving insulin therapy will be able to administer insulin injections correctly, effectively, and regularly after the training. Consequently, complications related to diabetes and insulin injections will decrease, hospitalizations will decrease, effective glycemic control will be achieved, and the quality of life of individuals will improve. A summary oral presentation and a publication will be produced from the results of the study, contributing to the literature. MATERIALS AND METHODS 3.1. Type of Research This research is planned as a randomized controlled experimental study. 3.2. Location and Time of Research The research will be conducted at Reşadiye State Hospital between June 2024 and June 2025. 3.3. Population and Sample of the Research The population of the research will consist of patients who apply to Reşadiye State Hospital, are diagnosed with Type 1 and Type 2 DM, and use insulin. The sample of the research will include Type 1 and Type 2 diabetic patients who meet the inclusion criteria (diagnosed with Type 1 and Type 2 Diabetes for at least six months, receiving insulin treatment, capable of self-administering insulin injections, between the ages of 18-65, at least primary school graduate, without a psychiatric illness or communication impairment (vision, hearing, and speech), able to use a mobile phone and send and receive SMS messages, and agree to participate in the research). The "G. Power-3.1.9.7" program was used to calculate the sample size for the study. Considering a two-group (Intervention Group, Control Group) and two-measurement (Pretest, Posttest) research design, the sample size was calculated using the independent samples t-test. To achieve 80% power with a high effect size at a 0.05 significance level and a 95% confidence interval, the target sample size was 102 individuals, 51 in each intervention and 51 in the control group. However, assuming some losses, 10% of the sample size was added, resulting in a total of 112 patients (56 in the intervention group and 56 in the control group). Randomized Selection Between June 2024 and June 2025, 112 individuals meeting the study participation criteria and diagnosed with Type 1 and Type 2 Diabetes Mellitus (DM) who presented to Reşadiye State Hospital will be selected using a simple random sampling method. It is planned that 56 patients will be included in the experimental group and 56 patients in the control group using a randomization method (using the software at http://www.randomizer.org). During this process, a list of 112 patients who voluntarily agree to participate in the study will be created. Patients on this list will be numbered from 1 to 112. Then, using the software at http://www.randomizer.org, 56 of the 112 numbered patients will be randomly assigned to the experimental group and 56 to the control group. After the assignment, patients corresponding to the numbers in the experimental group will be included in the experimental group, and patients corresponding to the numbers in the control group will be included in the control group. 3.4. Inclusion and Exclusion Criteria for the Study Inclusion criteria: 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 therapy Capable of self-administering insulin injections Free from psychiatric illness or communication impairments (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. Exclusion criteria: Not using insulin therapy Using an insulin pump Having temporary insulin therapy Having lipodystrophy Individuals who refuse to participate in the study or who discontinue their education. 3.5. Study Variables Dependent Variables: Patient Identification Form, Insulin Therapy Self-Management Scale Independent Variables: Insulin injection training given using the color rotation technique. 3.6. Research Hypotheses; Hypothesis (H0): Training given to diabetic patients using the color rotation technique has no effect on insulin self-management. Hypothesis (H1): Training given to diabetic patients using the color rotation technique has an effect on insulin self-management. Hypothesis (H2): Training given to diabetic patients using the color rotation technique has no effect on metabolic variables. Hypothesis (H3): Training given to diabetic patients using the color rotation technique has an effect on metabolic variables. 3.7. Stages of the Research Implementation of the Research Data will be collected by the researcher through face-to-face interviews with Type 1 and Type 2 DM patients who applied to Reşadiye State Hospital. The Patient Identification Form, prepared in accordance with the literature and containing socio-demographic characteristics and information about the disease, and the Insulin Treatment Self-Management Scale, which aims to evaluate the knowledge and skill level of diabetic individuals regarding insulin treatment, will be used to collect research data. Patients who meet the sample selection criteria and agree to participate in the study will be randomized to form control and intervention groups. All patients who agree to participate (control and intervention groups) will be informed of the study's purpose during the initial interview, and after obtaining verbal and written consent, data collection tools will be administered. Intervention Group The initial encounter with individuals with diabetes will take place at the Internal Medicine Outpatient Clinic and Ward of Reşadiye State Hospital. The initial interview will be conducted individually in the hospital's training room using a face-to-face interview method and will last approximately 30-40 minutes. Patients will be informed about the subject, purpose, and importance of the study, and after obtaining their consent, their name and mobile phone number will be recorded on the Patient Identification Form. Data will be collected by the researcher using the Patient Identification Form and the Insulin Therapy Self-Management Scale to assess the knowledge and skill level of individuals with diabetes regarding insulin treatment. Metabolic variables included in the Patient Identification Form will be retrieved from the hospital data system and recorded by the researcher during the pre-test and post-test phases, subject to institutional permission. Blood pressure will be measured in the clinic using a blood pressure monitor, in accordance with the technique recommended in the national hypertension treatment and follow-up guidelines. Measurements will be taken from both arms with the patient in a seated position, both during the pre-test and post-test phases. The average of the two measurements will be recorded. After completing the forms, a schedule for the next meeting will be created, and patients will be informed that they will be invited to the hospital for diabetes education one week later. They will also be contacted by phone to remind them of the invitation. During the second meeting, patients will be individually taken to the education room at their scheduled time and given face-to-face training. Patients will receive education on diabetes and insulin injections using an educational booklet prepared by the researcher based on the literature and expert opinions, covering the topics in the booklet. Patients will be asked to perform injections using a mannequin, demonstrating their routine practice. The mannequin for the demonstration will be provided by the unit where the research is being conducted. Any knowledge and skill gaps in patients regarding diabetes and insulin injections will be identified, and more detailed information will be provided in these areas. 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 model. Rotation training will be provided to remind patients of the rotation plan and needle tip changes with each injection. Colored boxes with visually colored rotation zones and needle tip placement will be used to help them remember the rotation change. Each patient session will last approximately 30-45 minutes. Patients will be given an educational booklet prepared with expert advice. The conversation with the patient will be clear and understandable. Any questions patients may have after the training will be answered. The educational booklet will include information on: What is diabetes, types of diabetes, symptoms of diabetes, diagnosis of diabetes, monitoring and treatment of diabetes, blood sugar measurement, monitoring of metabolic variables, how to use a blood glucose meter, how to measure blood sugar and precautions to take during measurement, and complications of insulin. Patients will receive SMS messages from the researcher reminding them of their daily injection time, rotation, and needle tip changes. The content of the SMS messages will include: - Measure your blood sugar before administering insulin. - Administer insulin at the times and in the appropriate doses recommended by your doctor. * Remember to regularly change the injection sites during your insulin applications. * Remember to change the tip of your insulin needle with each application. The third meeting will be scheduled for two weeks later, based on the principles of the second meeting, and diabetes education will be conducted according to the same principles. It will be explained that patients will be invited back to the hospital for the final test phase three months later, and the education will be concluded. An appointment will be scheduled and a reminder will be given a few days in advance. In the fourth meeting, patients will be interviewed individually face-to-face in the education room at the time they are called. Data collection tools will be applied again for the final test. Metabolic variables will be retrieved from the hospital data system with institutional permission and recorded by the researcher. Blood pressure will be measured in the final test phase by the researcher with the patient in a seated position, using the blood pressure monitor in the clinic, according to the technique recommended in the national hypertension treatment and follow-up guidelines. The average of the two measurements will be recorded. Patients will be asked to perform insulin injections again using a mannequin. Diabetes education will be conducted again using the training booklet. The study will be concluded with a thank participants to the participants. Control Group The first encounter with diabetic individuals in the control group will take place at the Internal Medicine Outpatient Clinic and Ward of Reşadiye State Hospital. The first interview will be conducted individually with patients in the hospital's training room using a face-to-face interview method and will last approximately 30-40 minutes. Patients will be informed about the subject, purpose, and importance of the research, and after obtaining their consent, their name and mobile phone number will be recorded on the Patient Identification Form. During the first interview, it is planned that the researcher will complete pre-tests using the Patient Identification Form and the Insulin Therapy Self-Management Scale to assess the knowledge and skill level of diabetic individuals regarding insulin treatment, using a face-to-face interview method. Metabolic variables and blood pressure measurements will be taken and recorded. For the second interview, patients will be invited to the hospital one week later, and a reminder of the appointment will be given by phone a few days in advance. Patients will gather individually in the training room at the determined times using a face-to-face interview method. Patients will be asked to administer injections using a mannequin, in the manner they routinely apply. The model to be used for the demonstration will be obtained from the unit where the research will be conducted. Patients' knowledge and skill deficiencies regarding diabetes and insulin injections will be identified. No intervention will be performed on patients in the control group. Patients in the control group will also be given a diabetes education booklet, considering their ethical right to be informed. The third interview will be conducted three months later, simultaneously with the intervention group, to collect final test data. Patients will be invited to the hospital on the designated day and time to have the data collection tools administered. At the end of the research, patients will be thanked for their participation, and the research will be concluded. 3.8. Data Collection Tools For the collection of research data, a Patient Identification Form, created in accordance with the relevant literature and containing the patient's socio-demographic and disease-related characteristics and metabolic values, and the Insulin Treatment Self-Management Scale, which will assess the knowledge and skill levels and positive-negative attitudes of diabetic individuals regarding insulin treatment, will be used. • Patient Identification Form (Appendix-1): The patient identification form to be used in the collection of research data was created by the researcher in accordance with the relevant literature. The patient identification form includes questions to determine the socio-demographic and disease-related characteristics and metabolic status of the patients. The patient identification form includes information such as age, gender, occupation, marital status, education level, income level, chronic disease status, type of diabetes, duration of diabetes diagnosis, duration of insulin use, self-administration of insulin injections, completion of insulin doses, daily number of injections, diabetes education, insulin injection training, adherence to rotation technique, needle reuse, presence of lipohypertrophy, and metabolic values. • Insulin Therapy Self-Management Scale (Appendix-2): The Insulin Therapy Self-Management Scale is a scale used to evaluate the knowledge and skill levels and positive-negative attitudes of individuals with diabetes regarding insulin therapy. This scale was developed by Karahan Okuroğlu and colleagues in 2019. 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, including the item "I don't inject myself with insulin," are analyzed using reverse coding due to their negative connotations. An increase in scores across all subscales indicates an increase in self-management levels in that subscale. The Cronbach α coefficient for the scale and subscales is reported to be between 0.86 and 0.91. Data Evaluation The data obtained from the research will be analyzed using SPSS 22 software for statistical analysis. The significance level will be set at 0.05 for all analyses. Descriptive statistical methods (mean, standard deviation, median, frequency, percentage, minimum, maximum) will be used when evaluating the study data. The normality of the data distribution will be evaluated using the Kurtosis and Skewness coefficient tests. Independent samples t-tests will be used for comparing pairs of groups, and dependent samples t-tests will be used for within-group comparisons of pairs of groups. Chi-square will be used to compare patient characteristics in the experimental and control groups. 3.9. Ethical Principles of the Research Ethical and Legal Aspects of the Research: Before starting the research, ethical committee approval and written permission were obtained from the Atatürk University Faculty of Medicine Ethics Committee (NUMBER: B. 30. 2. ATA. 0.01.00/299). Institutional permission will be obtained from Reşadiye State Hospital, where the research will be conducted. Participants will be informed about the research, and written and verbal consent will be obtained by fulfilling the principle of "Informed Consent," stating that they are free to participate or not participate in the research, the principle of "Respect for Autonomy," and stating that the information of the participants will be kept confidential, the principle of "Confidentiality and Protection of Privacy." Those willing to participate in the research will be included in the study. Permission will be obtained from the person who validated the reliability of the scale to be used in the research. 4\. RELATIONSHIP WITH PRIORITY AREAS Internal medicine nursing is an important specialty area aimed at improving the quality of life of patients with Diabetes Mellitus. In this context, the use of non-pharmacological methods is gaining increasing importance. Insulin injection training for diabetic patients is a practice that ranks among the top priorities in disease management and will positively contribute to the physiological, psychological, and social improvement of diabetic patients, contribute to the individual and national economy, and positively improve the quality of life of patients. Within the scope of internal medicine nursing, it should not be overlooked that the most important aspect in the management of diabetes is insulin injection training given with the correct technique. This non-pharmacological approach can contribute to improving the quality of life of diabetic patients by managing diabetes. Nurses can improve disease management and improve the quality of life of patients by observing the insulin application techniques of diabetic patients and including insulin injection training in care plans.

Conditions

• Diabete Mellitus
• İnsulin Self-management

Interventions

Type	Name	Description
BEHAVIORAL	Education	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.

Timeline

• Start date: 2026-04-15
• Primary completion: 2026-07-22
• Completion: 2026-07-22
• First posted: 2026-03-30
• Last updated: 2026-04-08