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IRCT20221024056280N1 IRCT 2023-05-15 Babol University of Medical Sciences Effectiveness of midwife-led postpartum counseling on psychological distress Effectiveness of midwife-led postpartum counseling on psychological distress in women with traumatic childbirth 2023-05-22 anticipated 96 Complete https://irct.ir/trial/69438 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The sequence of random allocation and the list of blocks will be obtained with the help of software (https://www.sealedenvelope.com) in blocks of 4. Blocking and allocation sequence for concealment will be done by a person not involved in the research. The allocation ratio of the samples will be 1.1 and will be placed in two groups receiving counseling and control. Then, based on the obtained blocks and the sequence of allocation, counseling will be given to the patients who reported a traumatic childbirth. This is an open-label study and blinding will not happen. N/A postpartum psychological distress. Intervention 1: In the intervention group, counseling is performed on the basis of "the Gamble's strategy" individually for 3 sessions, one sessions of face-to-face contact consultation during the first 72 hours after child birth and two session of telephone consultations in the fourth week and the eighth week after delivery, ranging 40 - 60 minutes by the researcher midwife. The counseling intervention is consistent with trauma theory and draws on cognitive behavioral therapy principles (C B T). Counseling strategies provided women with opportunities to talk about their birth experience, express feelings about what happened. The counseling intervention including fostering social support, reinforcing positive approaches to coping and exploring solutions to restoring self-confidence and reducing anxiety. Intervention 2: Control group: The control group will be received usual care after childbirth. 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 further information.
public Mouloud Aghajani Delavar
Babol University of Medical Sciences, Ganj Afrooz Ave, Daneshga Blvd, Babol
Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11 3219 9592 molooodaghajani@yahoo.com Babol University of Medical Sciences scientific Mouloud Aghajani Delavar
Babol University of Medical Sciences, Ganj Afrooz Ave, Daneshga Blvd, Babol
Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11 3219 9592 molooodaghajani@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) age range 18-35 years mother's willingness and consent to participate in the study singleton pregnancy ability to complete questionnaires 18 years 35 years Female history of infertility history of abortion history of stillbirth history of postpartum depression in first-degree relatives depression during pregnancy mental illness medical disorder occurrence of an unfortunate accident during the last 6 months O90.6 Postpartum mood disturbance Prevention Prevention In the intervention group, counseling is performed on the basis of "the Gamble's strategy" individually for 3 sessions, one sessions of face-to-face contact consultation during the first 72 hours after child birth and two session of telephone consultations in the fourth week and the eighth week after delivery, ranging 40 - 60 minutes by the researcher midwife. The counseling intervention is consistent with trauma theory and draws on cognitive behavioral therapy principles (C B T). Counseling strategies provided women with opportunities to talk about their birth experience, express feelings about what happened. The counseling intervention including fostering social support, reinforcing positive approaches to coping and exploring solutions to restoring self-confidence and reducing anxiety. Control group: The control group will be received usual care after childbirth. Postpartum psychological distress. Timepoint: Measurement at the beginning of the study (before the start of the intervention) and 12 weeks after birth. Method of measurement: Using Stanford Acute Stress Reaction Questionnaire, Impact of Event Scale - Revised, and post-traumatic stress checklist inventory. State-trait anxiety inventory. Timepoint: Before the intervention and 12 weeks after child birth. Method of measurement: Spielberger State-Trait Anxiety Inventory (STAI-20). Babol University of Medical Sciences Approved 2023-03-06 Ethics committee of Babol University of Medical Sciences Babol University of Medical Sciencesol, Ganj Afrooz Ave, Daneshga Blvd, Babol Babol Mazandaran Iran (Islamic Republic of)