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IRCT20120215009014N409 IRCT 2021-11-27 Hamedan University of Medical Sciences Effect of education and nurse-led telephone follow ups (Tele-nursing) versus control group on self-efficacy and quality of life in diabetic pregnant women Effect of education and nurse-led telephone follow ups (Tele-nursing) versus control group on self-efficacy and quality of life in diabetic pregnant women: a single-blind randomized clinical trial 2021-12-16 anticipated 80 Complete https://irct.ir/trial/60229 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached, Blinding description: The examiner will not be aware of the education of pregnant women. Thus, the trial will be run as single-blind. N/A Gestational diabetes mellitus. Intervention 1: Intervention group: Routine education and care for diabetic pregnant women plus education and nurse-led telephone follow via Tele-nursing (including the amount of physical activity, type of diet, nutrients required at each meal, the importance of observing and performing blood sugar tests, identifying the signs and symptoms of hypoglycemia, self-care and improving quality of life) each time for 15 minutes twice a week in the first month and once a week in the second month (totally 12 times). Intervention 2: Control group: Routine education and care for diabetic pregnant women. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It depends on the situation and the results of the study as well as the approval of the financial supporting organization.
public Maryam Garoosian
Fatemieh Hospital, Pasdaran Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3828 3939 maryam13462000@yahoo.com Hamedan University of Medical Sciences scientific Dr. Shahla Nasrolahi
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 sh_nasrolahi@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age of 18 to 45 years: Gestational diabetes; Literate; Possibility of making direct telephone calls with the patient or her active family member; 18 years 45 years Female Failure to answer the phone call three times; O24.4 Gestational diabetes mellitus Other Other Intervention group: Routine education and care for diabetic pregnant women plus education and nurse-led telephone follow via Tele-nursing (including the amount of physical activity, type of diet, nutrients required at each meal, the importance of observing and performing blood sugar tests, identifying the signs and symptoms of hypoglycemia, self-care and improving quality of life) each time for 15 minutes twice a week in the first month and once a week in the second month (totally 12 times) Control group: Routine education and care for diabetic pregnant women Self-efficacy. Timepoint: Before the intervention and 8 weeks after that. Method of measurement: Using the Diabetes Management Self-Efficacy Scale (DMSES). Quality of life. Timepoint: Before the intervention and 8 weeks after that. Method of measurement: Using Quality of Life Questionnaire for Diabetes Mellitus (QOLDP). Hamedan University of Medical Sciences Approved 2021-10-22 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)