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IRCT20151208025431N7 IRCT 2018-12-07 Tehran University of Medical Sciences Comparing the effect of "Motivational Interviewing" with "Information, Motivation and Behavioural skills" on choosing mode of delivery in pregnant women Comparing the effect of "Motivational Interviewing" with "Information, Motivation and Behavioural skills" on choosing mode of delivery in pregnant women 2018-11-22 anticipated 360 Complete https://irct.ir/trial/32356 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: \regnant women (GA: 6.7 and 8 months) referred to the four public hospitals affiliated to Tehran University of Medical Sciences will randomly be assigned to one of the intervention or control groups. N/A Cesarean Section. Intervention 1: Intervention Based on Information, Motivation and Behavioral Skills Model: This will be a tailored intervention based on the needs of target group. According to this model, necessary information about the deficiencies in the information, motivation and behavioral skills will be delivered to the participants after a needs assessment through interviews and focus groups discussions. Each group will be consisted of 8-12 participants. The Intervention will have three sections: Information will be provided in 45 minutes using lectures and appropriate teaching aids (PPT slides, educational videos, whiteboards, markers, etc.) to provide better information to pregnant women. For promoting the motivation and behavior, reasons for change will be discussed and feedback will be provided. These three sections will be presented within three sessions for each group. Thus, we will have 18 sessions. Intervention 2: Intervention based on mobile app; This app will be installed in the phone of the participants. The functions will be trained individually. Patients will work in conjunction with an application-oriented research team and any existing problems will be resolved. The predicted strategies for improving adherence includes reminders that are set up at pop-ups at specified intervals. To monitor adherence, data collected on the server is used. By designing a server, users' activities will be gathered. Items such as the time the application is open and specific parts that are used by the user will be recorded. Each time the user's mobile phone is connected to the Internet, the data will be loaded and stored on the server. This data will be used as a proxy for joining the intervention. In addition, to facilitate women's communication with each other, a chat room will be created in which pregnant women will share their experiences with others. Women can ask questions or contact other pregnant women. Intervention 3: Intervention based on face-to-face motivational interviews: In this group, pregnant women will be taught face-to-face based on motivational interviews (8-10 individuals in each group). The duration of the sessions will be 45-60 minutes. A brief intervention based on the motivational interview will be conducted by the researcher. During the intervention, women will be acquainted with the purposes in the first session, the norms and processes of the group will be presented. Emotions affecting behaviors will be identified. A homework assignment will be determined. In the second session, discussions will be held on the positive and negative dimensions of behavior. In the third session, values will be identified and prioritized, and the view will be drawn for behavior change. 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 There is no more information.
public Dr Elham Shakibazadeh
School of Public Health,Tehran University of Medical Sciences, Enghelab ST
Tehran Iran (Islamic Republic of) 1417613151 +98 21 4293 3333 elham50sh@yahoo.com Tehran University of Medical Sciences scientific Elham Shakibazdeh
School of Public Health,Tehran University of Medical Sciences, Enghelab ST
Tehran Iran (Islamic Republic of) 1417613151 +98 21 4293 3214 elham50sh@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Ability to speak Farsi literacy Being pregnant Having single pregnancy; Gestational age: 6, 7, and 8 months; No complications in pregnancy; No indication for Cesarean section Having enough time to participate in the study Having smartphone and ability to work with the Mobile App no limit no limit Female O75.82 Onset (spontaneous) of labor after 37 completed weeks of gestation but before 39 completed weeks gestation, with delivery by (planned) cesarean section Behavior Behavior Behavior Intervention Based on Information, Motivation and Behavioral Skills Model: This will be a tailored intervention based on the needs of target group. According to this model, necessary information about the deficiencies in the information, motivation and behavioral skills will be delivered to the participants after a needs assessment through interviews and focus groups discussions. Each group will be consisted of 8-12 participants. The Intervention will have three sections: Information will be provided in 45 minutes using lectures and appropriate teaching aids (PPT slides, educational videos, whiteboards, markers, etc.) to provide better information to pregnant women. For promoting the motivation and behavior, reasons for change will be discussed and feedback will be provided. These three sections will be presented within three sessions for each group. Thus, we will have 18 sessions. Intervention based on mobile app; This app will be installed in the phone of the participants. The functions will be trained individually. Patients will work in conjunction with an application-oriented research team and any existing problems will be resolved. The predicted strategies for improving adherence includes reminders that are set up at pop-ups at specified intervals. To monitor adherence, data collected on the server is used. By designing a server, users' activities will be gathered. Items such as the time the application is open and specific parts that are used by the user will be recorded. Each time the user's mobile phone is connected to the Internet, the data will be loaded and stored on the server. This data will be used as a proxy for joining the intervention. In addition, to facilitate women's communication with each other, a chat room will be created in which pregnant women will share their experiences with others. Women can ask questions or contact other pregnant women. Intervention based on face-to-face motivational interviews: In this group, pregnant women will be taught face-to-face based on motivational interviews (8-10 individuals in each group). The duration of the sessions will be 45-60 minutes. A brief intervention based on the motivational interview will be conducted by the researcher. During the intervention, women will be acquainted with the purposes in the first session, the norms and processes of the group will be presented. Emotions affecting behaviors will be identified. A homework assignment will be determined. In the second session, discussions will be held on the positive and negative dimensions of behavior. In the third session, values will be identified and prioritized, and the view will be drawn for behavior change. Pregnant women's behavioral intention on choosing mode of delivery. Timepoint: Pretest and post-test. Method of measurement: Questionnaire. Pregnant women's self-efficacy on choosing mode of delivery. Timepoint: Pretest and post-test. Method of measurement: Questionnaire. Mode of delivery. Timepoint: Pretest and post-test. Method of measurement: Questionnaire. Usability of the mobile app. Timepoint: 3 month. Method of measurement: Questionnaire. Mode of Delivery. Timepoint: 3 month. Method of measurement: Questionnaire. Tehran University of Medical Sciences Approved 2018-10-03 Ethics committee of tehran University of Medical Sciences Faculty of Health,Tehran University of Medical Sciences, Enghelab ST Tehran Tehran Iran (Islamic Republic of)