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IRCT20230924059498N1 IRCT 2023-11-18 Arak University of Medical Sciences The effect of Peplau's theory on blood sugar control and self-care in type 1 diabetes The effect of implementing an intervention based on Peplau's theory on blood sugar control and self-care of adolescents with type 1 diabetes 2024-02-04 anticipated 40 Complete https://irct.ir/trial/73217 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The researcher will talk to the teenagers and their parents and explain the purpose of the research and the method of implementation to them and get their consent to participate in the research. If they agree to participate in the research, their names will be registered in the list of research samples. Then, the researcher will code the specified names and assign them to two equal intervention and control groups by simple random method using SPSS software. N/A Diabetes Type 1. Intervention 1: Intervention group: the researcher calls the participants to the diabetes association and introduces himself and the objectives of the study to them, and after receiving informed consent, to each of the participants a three-part questionnaire, demographic information questionnaire, Tobert diabetes self-care questionnaire and delivers the blood sugar monitoring checklist. Regarding the blood sugar monitoring checklist, the researcher explains to the patients that they should write down their fasting and two-hour post-breakfast blood sugar levels for 7 days. In the same way, it is explained to the participants that they should start filling the desired sheet from the day after the meeting and finally deliver it to the researcher next week. It is explained to the participants that they should bring the questionnaires with them in the next meeting which will be held next week. At this stage, after gathering the participants, the beginning of the training sessions and the days of the class are explained to the teenagers and it is stated that two training sessions will be held every week. Blood sugar control sheets are collected from patients and their blood sugar management status is checked. Training sessions will be held according to the third stage of Peplav's theory (exploitation stage). Teaching teenagers will be done using lectures, group discussions, pictures and educational videos. Also, based on the determined self-care needs, several sessions of practical training classes are organized. The training program will be implemented in one-hour sessions and the number of sessions depends on the prioritization of needs. At the end, a booklet containing the content of the training will be provided to all samples (intervention and control groups). The fourth stage is called dissolution, which ends the training process. The participants are prepared for this stage from the previous two sessions. If there is any ambiguity or question, it will be answered in this meeting. Two months (8 weeks) after the completion of the training sessions, the participants will be contacted again and the two-part Tobert diabetes self-care questionnaire and blood sugar monitoring will be delivered to them. Finally, the researcher coordinates with the samples and receives the questionnaire from them. Intervention 2: Control group: In order to prevent the occurrence of possible biases due to the meeting of intervention and control group people in the diabetes association and to inform the control group people about the training sessions of the intervention group and the effect on them, the research was first on the participants of the control group and then It will be done on the intervention group. The researcher calls the participants to the Diabetes Association and obtains the informed consent form from them and their parents and then asks the teenagers to complete the questionnaires that are given to them. The questionnaires have three parts and are filled according to the mentioned instructions. After a week, they will be contacted and asked to hand over the questionnaires. In order to prevent errors in the research and to create coordination between the intervention and control groups, an 8-week interval is considered from the moment of delivery of the questionnaire, and then the questionnaires are filled again. No special action is taken in this group. Yes - There is a plan to make this available What will be shared: Information such as age of teenagers, education of parents, duration of type 1 diabetes in teenagers (in years), body mass index of teenagers, types of insulin used by teenagers, diabetes self-care score of teenagers with type 1 diabetes before and after intervention in each group ( control and intervention), the average fasting blood sugar score and 2 hours after the meal before and after the intervention in each group in teenagers with type 1 diabetes. The information will be published without mentioning names and individual characteristics. When: The access period starts 6 months after the results are published To whom: Only researchers working in academic institutions and hospitals Conditions: Free access is provided on the condition of correct and ethical use in order to improve self-care and blood sugar control of adolescents with type 1 diabetes and referring to the information of this research and preserving the rights of the researchers of this project. Where to obtain: Sara Samie sarasamie81@gmail.com How to obtain: Send name and surname; field of study; university of study; reason for needing said information; type of requested data; only via email Comments:
public Sara Samie
Etehad 1 Alley, Etehad Ave., Hamid Town
Arak Iran (Islamic Republic of) 3816985776 +98 86 3435 1361 s.samiei@arakmu.ac.ir Arak University of Medical Sciences scientific Somaye Sayahi
Faculty of Nursing, Payambar-e-Azam University complex, Sardasht
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3524 s.sayahi@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Type 1 diabetes diagnosis by a specialist doctor and recorded in the patient's medical record At least three months have passed since the diagnosis of type 1 diabetes in the patient Willingness and ability of adolescents and parents to participate in the study Adolescents must be between 12 and 18 years old 12 years 18 years Both Adolescents suffering from diseases other than diabetes E10.9 Type 1 diabetes mellitus without complications Other Other Intervention group: the researcher calls the participants to the diabetes association and introduces himself and the objectives of the study to them, and after receiving informed consent, to each of the participants a three-part questionnaire, demographic information questionnaire, Tobert diabetes self-care questionnaire and delivers the blood sugar monitoring checklist. Regarding the blood sugar monitoring checklist, the researcher explains to the patients that they should write down their fasting and two-hour post-breakfast blood sugar levels for 7 days. In the same way, it is explained to the participants that they should start filling the desired sheet from the day after the meeting and finally deliver it to the researcher next week. It is explained to the participants that they should bring the questionnaires with them in the next meeting which will be held next week. At this stage, after gathering the participants, the beginning of the training sessions and the days of the class are explained to the teenagers and it is stated that two training sessions will be held every week. Blood sugar control sheets are collected from patients and their blood sugar management status is checked. Training sessions will be held according to the third stage of Peplav's theory (exploitation stage). Teaching teenagers will be done using lectures, group discussions, pictures and educational videos. Also, based on the determined self-care needs, several sessions of practical training classes are organized. The training program will be implemented in one-hour sessions and the number of sessions depends on the prioritization of needs. At the end, a booklet containing the content of the training will be provided to all samples (intervention and control groups). The fourth stage is called dissolution, which ends the training process. The participants are prepared for this stage from the previous two sessions. If there is any ambiguity or question, it will be answered in this meeting. Two months (8 weeks) after the completion of the training sessions, the participants will be contacted again and the two-part Tobert diabetes self-care questionnaire and blood sugar monitoring will be delivered to them. Finally, the researcher coordinates with the samples and receives the questionnaire from them. Control group: In order to prevent the occurrence of possible biases due to the meeting of intervention and control group people in the diabetes association and to inform the control group people about the training sessions of the intervention group and the effect on them, the research was first on the participants of the control group and then It will be done on the intervention group. The researcher calls the participants to the Diabetes Association and obtains the informed consent form from them and their parents and then asks the teenagers to complete the questionnaires that are given to them. The questionnaires have three parts and are filled according to the mentioned instructions. After a week, they will be contacted and asked to hand over the questionnaires. In order to prevent errors in the research and to create coordination between the intervention and control groups, an 8-week interval is considered from the moment of delivery of the questionnaire, and then the questionnaires are filled again. No special action is taken in this group. Diabetes self-care score in Tobert questionnaire. Timepoint: The effect of designing and implementing an (educational) intervention based on Peplau's theory on the self-care of adolescents with type 1 diabetes, before the intervention and 8 weeks after the intervention. Method of measurement: Tobert diabetes self-care questionnaire. Average fasting blood sugar score. Timepoint: The effect of implementing of the intervention based on Peplau's theory on the average fasting blood sugar score before the intervention and 8 weeks after the end of the intervention. Method of measurement: Glucometer device (to complete the fasting blood sugar monitoring checklist). Average blood sugar score two hours after a meal. Timepoint: The effect of the implementation of the intervention based on the Peplau theory on the average blood sugar score two hours after the meal, before the intervention and 8 weeks after the end of the intervention. Method of measurement: Glucometer device (to complete the blood sugar monitoring checklist two hours after meals). Arak University of Medical Sciences Approved 2023-10-14 Ethics Committee of Arak University of Medical Sciences Faculty of Nursing, Payambar-e-Azam university complex, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)