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IRCT20240128060831N1 IRCT 2024-02-19 Tabriz University of Medical Sciences The effect of the doula support on childbirth experience and breastfeeding performance after cesarean section The effect of the doula support on childbirth experience and breastfeeding function after cesarean section: A randomized controlled clinical trial 2024-04-02 anticipated 84 Complete https://irct.ir/trial/75203 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible people will be assigned to intervention and control groups by random block method with block sizes of 6 and 4 and with an allocation ratio of 1:1 and classification based on nulliparousness or history of one cesarean section. The Randomizer software will be used to create the allocation sequence. Allocation sequence concealment will be done by someone other than the person involved in sampling and data collection. For Allocation Concealment, the type of intervention will be written on a sheet of paper and placed inside opaque envelopes numbered from 1 to 84. The envelopes will be opened in the order in which the participants entered the study and the type of intervention received will be determined. N/A Breastfeeding. Intervention group: The intervention group, in addition to the usual care in the operating room, from one hour before the cesarean section to two hours after the operation, the doula support in the form of emotional-psychological, physical and educational support in order to reduce anxiety and stress and increase her self-confidence, encouragement, companionship, reassurance, respect for the mother in decision-making, helping to communicate with other caregivers, empathetic relationship with mother and his family, constant presence and sympathetic behavior, giving hope and encouragement, creating a positive attitude about the birth of the baby, establishing skin-to-skin contact to the skin of the mother and the baby by placing the baby on the mother's chest immediately after the operation, helping the mother to start breastfeeding successfully one hour after birth, providing information such as answering her questions about the cesarean procedure with understandable answers, teaching how They will have baby care, proper breastfeeding and training on how to milk milk and store it when needed, baby vaccination, nutrition and personal hygiene, and additional training on self-care during the postpartum period. All actions taken by the researcher will be recorded by the prepared checklist. This checklist includes supportive actions of the doula consisting of 34 questions in three parts, one hour before cesarean section, during cesarean section, and up to two hours after cesarean section. Also, at the end of this checklist, there are four open-ended questions that evaluate the mother's expectations from the doula and their experiences of having a doula.. 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 Participant data is confidential
public Vahideh Hadavi
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
Tabriz Iran (Islamic Republic of) 5135963777 +98 41 3479 6770 vhhadavi70@gmail.com Tabriz University of Medical Sciences scientific Reyhaneh Ivanbagha
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 ivanbagha@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Pregnant women with a gestational age of 37 weeks or more nulliparous women with the first non-emergency cesarean section (cesarean section in cases such as breech presentation, cephalopelvic disproportion (CPD), fetal macrosomia, fetal distress, placental abruption) and without the onset of labor symptoms Women with a history of one caesarean section and no history of natural childbirth and no onset of labor symptoms Absence of disease or abnormality of the baby at birth Having the ability to breastfeed Having literacy in reading and writing to answer questions A resident of Tabriz no limit no limit Female Mother's unwillingness to have a doula Mothers with mental illnesses such as depression, etc. according to the mother's statement or medical record Mothers with physical diseases that prevent breastfeeding, such as mastectomy The need to perform another surgery (hysterectomy) for the mother during cesarean section Contraindications and precautions in breastfeeding (untreated tuberculosis, chicken pox, measles, hepatitis, Malt fever, AIDS, chemotherapy, infant galactosomia, herpes lesions on the breast, use of certain drugs, breast abscess, mastitis, drug use, etc.) Mother's speech and hearing disorders Behavior Intervention group: The intervention group, in addition to the usual care in the operating room, from one hour before the cesarean section to two hours after the operation, the doula support in the form of emotional-psychological, physical and educational support in order to reduce anxiety and stress and increase her self-confidence, encouragement, companionship, reassurance, respect for the mother in decision-making, helping to communicate with other caregivers, empathetic relationship with mother and his family, constant presence and sympathetic behavior, giving hope and encouragement, creating a positive attitude about the birth of the baby, establishing skin-to-skin contact to the skin of the mother and the baby by placing the baby on the mother's chest immediately after the operation, helping the mother to start breastfeeding successfully one hour after birth, providing information such as answering her questions about the cesarean procedure with understandable answers, teaching how They will have baby care, proper breastfeeding and training on how to milk milk and store it when needed, baby vaccination, nutrition and personal hygiene, and additional training on self-care during the postpartum period. All actions taken by the researcher will be recorded by the prepared checklist. This checklist includes supportive actions of the doula consisting of 34 questions in three parts, one hour before cesarean section, during cesarean section, and up to two hours after cesarean section. Also, at the end of this checklist, there are four open-ended questions that evaluate the mother's expectations from the doula and their experiences of having a doula. Childbirth experience score. Timepoint: Between four and six weeks after cesarean delivery. Method of measurement: questionnaire for assessing the childbirth experience (QACE). Breastfeeding performance score. Timepoint: Between four and six weeks after cesarean section. Method of measurement: Breastfeeding performance questionnaire. Depression score. Timepoint: Once between four and six weeks after cesarean section. Method of measurement: Edinburgh postpartum depression questionnaire. Anxiety score. Timepoint: Once between four and six weeks after cesarean section. Method of measurement: Specific postpartum anxiety questionnaire. Tabriz University of Medical Sciences Approved 2024-01-01 Ethics committee of Tabriz University of Medical Sciences Research department, third floor, central construction number2, Tabriz University of Medical Sciences, Golgasht street, Azadi street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)