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IRCT20120215009014N454 IRCT 2022-12-28 Hamedan University of Medical Sciences Effect of midwifery counseling with Gamble approach versus control group on post-traumatic stress disorder in women undergoing emergency caesarean section Effect of midwifery counseling with Gamble approach versus control group on post-traumatic stress disorder in women undergoing emergency caesarean section: a randomized clinical trial 2022-12-22 anticipated 70 Complete https://irct.ir/trial/67292 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 Post-traumatic stress disorder. Intervention 1: Intervention group: Usual services after caesarean section plus counseling with Gamble's approach individually and face-to-face for 40 to 60 minutes after caesarean section (including: good therapeutic communication between midwife and mother, acceptance of mother's perceptions about emergency caesarean section, mother's support in expressing her feelings and resolving her doubts about the emergency cesarean section, and strengthening the mother's positive thoughts to adapt to the situation, encouraging her to express her feelings and thoughts about childbirth through open questions, active listening and giving feedback on the mother's concerns, clarifying and removing misunderstandings and strengthening the mother's positive thoughts and providing solutions). Intervention 2: Control group: Usual services after caesarean section. 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 Soleimani
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 sol356432@gmail.com Hamedan University of Medical Sciences scientific Dr. Farzaneh Soltani
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 farzanehsoltani2008@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age 18 to 35 years Term and single birth Healthy baby 18 years 35 years Female History of mental illness History of infertility The need for admission to the intensive care unit F43.1 Post-traumatic stress disorder (PTSD) Other N/A Intervention group: Usual services after caesarean section plus counseling with Gamble's approach individually and face-to-face for 40 to 60 minutes after caesarean section (including: good therapeutic communication between midwife and mother, acceptance of mother's perceptions about emergency caesarean section, mother's support in expressing her feelings and resolving her doubts about the emergency cesarean section, and strengthening the mother's positive thoughts to adapt to the situation, encouraging her to express her feelings and thoughts about childbirth through open questions, active listening and giving feedback on the mother's concerns, clarifying and removing misunderstandings and strengthening the mother's positive thoughts and providing solutions) Control group: Usual services after caesarean section Incidence of post-traumatic stress disorder. Timepoint: 12 hours and 4 weeks after the caesarean section. Method of measurement: Using standard post-traumatic stress disorder questionnaire. 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)