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IRCT20120215009014N452 IRCT 2022-12-26 Hamedan University of Medical Sciences Effect of counseling with emotional self-regulation approach versus control group on the anxiety and fear of childbirth in the primiparous women Effect of counseling with emotional self-regulation approach versus control group on the anxiety and fear of childbirth in the primiparous women: a randomized clinical trial 2023-03-03 anticipated 70 Complete https://irct.ir/trial/67546 interventional Randomization: Randomized, Blinding: Not 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. N/A Anxiety and fear of childbirth in the first pregnany. Intervention 1: Intervention group: Routine care during pregnancy plus a counseling session with an emotional self-regulation approach for 45 to 60 minutes, one session per week for 6 sessions (Including: the necessity of emotion regulation in pregnancy and childbirth, normal emotions and problematic emotions, emotional self-awareness, identifying and naming emotions caused by the birth process, differentiating between different emotions, identifying emotions in physical and psychological states, success factors in regulating emotions From pregnancy and childbirth, pathogenic emotions in pregnancy and the necessity of their treatment, cognitive consequences of emotional reactions, physiological consequences of emotional reactions, facing emotions, breaking core and problematic beliefs and replacing new beliefs). Intervention 2: Control group: Just routine care during pregnancy. 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 همدان
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 ngrmasumi@gmail.com Hamedan University of Medical Sciences scientific Dr. Azita Tiznobaik
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 azita.tizno@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age 18 to 35 years Gestation age 23 to 28 weeks First singleton pregnancy Being literate 18 years 35 years Female Contraindications for natural childbirth History of infertility Mental illness Having diabetes, high blood pressure, thyroid disorder Smoking or drug use Occurrence of pregnancy complications such as gestational diabetes, preeclampsia, placenta Previa O99.344 Other mental disorders complicating childbirth Other N/A Intervention group: Routine care during pregnancy plus a counseling session with an emotional self-regulation approach for 45 to 60 minutes, one session per week for 6 sessions (Including: the necessity of emotion regulation in pregnancy and childbirth, normal emotions and problematic emotions, emotional self-awareness, identifying and naming emotions caused by the birth process, differentiating between different emotions, identifying emotions in physical and psychological states, success factors in regulating emotions From pregnancy and childbirth, pathogenic emotions in pregnancy and the necessity of their treatment, cognitive consequences of emotional reactions, physiological consequences of emotional reactions, facing emotions, breaking core and problematic beliefs and replacing new beliefs) Control group: Just routine care during pregnancy Anxiety and fear of pregnancy. Timepoint: Before intervention and two weeks after. Method of measurement: Using Vanderberg Pregnancy Anxiety Questionnaire (PRAQ). Hamedan University of Medical Sciences Approved 2022-12-03 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)