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IRCT20231204060261N1 IRCT 2024-05-20 Qazvin University of Medical Sciences Investigating the effect of Tele-counselling using Leventhal's self-regulation model on anxiety and depression of pregnant mothers with diabetes in Qazvin province in 2024 Investigating the effect of Tele-counselling using Leventhal's self-regulation model on anxiety and depression of pregnant mothers with diabetes in Qazvin province in 2024 2024-07-10 anticipated 70 Complete https://irct.ir/trial/76793 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: For random allocation, considering that there is an intervention method (consultation with Levanthal's self-adjustment method) and two control and intervention groups, random allocation sequence generation software will be used to change the allocation sequence to quadruple block method. Quadruple block method is used to avoid significant imbalances in the number of participants assigned to each group. Block randomization ensures that there is no significant imbalance between groups at any time during randomization, and at certain points the number of participants in each group is equal. By using the balanced block randomization method, they will be placed in two test and control groups with quadruple blocks. By choosing 20 blocks out of 6 possible blocks from the quadruple combination of the two test and control groups, the selection process will be The default form is specified and the patients will be assigned to two groups respectively. 1-AABB/ 2-ABBA/ 3-BAAB/ 4-ABAB/ 5-BABA/ 6-BBAA. N/A Investigating the effect of Tele-counselling using Leventhal's self-regulation model on anxiety and depression of pregnant mothers with diabetes in Qazvin province in 2024. Intervention 1: Intervention group: Intervention group: in the test group, in addition to receiving the usual care and training, their counseling needs are first determined and a counseling program is designed based on that. The educational content is based on the stages of Leventhal's self-regulation theory, before the intervention, questionnaires of demographic characteristics, mental health, understanding of the disease and adherence to treatment will be completed. Then, the researcher will start the intervention during three 30-minute sessions in three consecutive weeks by phone and individually, after the intervention, the mentioned questionnaires will be completed again immediately and one month and two months after the intervention. Intervention 2: Control group: The control group completes demographic, mental health, disease understanding and treatment compliance questionnaires and only receives training and routine care. Yes - There is a plan to make this available What will be shared: - When: - To whom: - Conditions: - Where to obtain: - How to obtain: - Comments: -
public nasim bahrami
Qazvin - Shahid Bahonar Boulevard - University Campus Complex - Faculty of Nursing and Midwifery
qazvin Iran (Islamic Republic of) 3419759811 +98 28 3333 6001 nbahrami@qums.ac.ir Qazvin University of Medical Sciences scientific nasim bahrami
Qazvin - Shahid Bahonar Boulevard - University Campus Complex - Faculty of Nursing and Midwifery
qazvin Iran (Islamic Republic of) 34197-59811 +98 28 3333 6001 f.rostami71@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in research Ability to speak and understand Farsi language Being in 6-10 weeks of pregnancy Diagnosing diabetes definitively by testing fasting blood sugar with a cut-off point of 93 and blood sugar 2 hours after a meal with a cut-off point of 120 and entering the mother's name as a pregnant mother with diabetes in the list of the health department of the province Suffering from depression and anxiety confirmed in the initial screening with a cut-off point of 12 no limit no limit Female Suffering from a known and diagnosed mental illness based on self-report and health records Suffering from other acute and chronic physical diseases at the same time such as blood pressure, kidney diseases, heart disease, multiple sclerosis, liver diseases based on the health record of the pregnant mother and the history of the disease as self-reported and entered in the medical record. Participation in psychological counseling sessions at the same time as the present study Other Other Intervention group: Intervention group: in the test group, in addition to receiving the usual care and training, their counseling needs are first determined and a counseling program is designed based on that. The educational content is based on the stages of Leventhal's self-regulation theory, before the intervention, questionnaires of demographic characteristics, mental health, understanding of the disease and adherence to treatment will be completed. Then, the researcher will start the intervention during three 30-minute sessions in three consecutive weeks by phone and individually, after the intervention, the mentioned questionnaires will be completed again immediately and one month and two months after the intervention. Control group: The control group completes demographic, mental health, disease understanding and treatment compliance questionnaires and only receives training and routine care. Depression and anxiety. Timepoint: Before the start of the intervention, immediately after, one month and two months after the intervention. Method of measurement: Demographic questionnaire, mental health, understanding of the disease, adherence to treatment. Understanding the disease, compliance with the treatment. Timepoint: Before the intervention, immediately, one month and two months after the intervention. Method of measurement: Demographic questionnaire, mental health, understanding of the disease, adherence to treatment. Qazvin University of Medical Sciences Approved 2024-05-12 Ethics Committee of Qazvin University of Medical Sciences Shahid Serhang Lashgari St., Shahid Gurban Ali Rostami Alley, first door ziaabad Qazvin Iran (Islamic Republic of)