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IRCT20200120046200N2 IRCT 2020-05-12 Iran University of Medical Sciences Comparison of the effect of companion and midwife presence during the mother-and-baby skin-to-skin contact Comparison of the effect of companion and midwife presence during the mother-and-baby skin-to-skin contact on pain and maternal anxiety and neonate physiological indices 2020-06-21 anticipated 92 Complete https://irct.ir/trial/46616 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random allocation for placement in the intervention and control group is done by random block method in four blocks and with allocation software: In this way, by entering the research units in the plan, by referring to the four blocks (letter A belongs to the intervention group and letter B belongs to the control group), the research units are assigned to the intervention and control groups. N/A Maternal pain and anxiety and assessment of neonatal physiological parameters. Intervention 1: Intervention group: Immediately after birth, the baby will be placed on the maternal abdomen, and dried, and the Apgar scores will be determined. If conditions will be appropriate for the skin-to-skin contact (SSC), the cord will be cut off after 3 minutes, and the head and back should be covered with a warm towel. The infant's axillary temperature, the saturation pressure oxygen (SPo2), and the heart rate (HR) will be measured using a mercury thermometer and a pulse oximeter, respectively. The maternal pain and anxiety will be evaluated on a visual analog scale, then, SSC is uninterrupted, and the baby will be placed on the mom's chest, (Baby's head between breasts), and then SSC will begin. This contact will continue at least one hour. In the intervention group, the mother's companion will perform SSC, while the researcher (midwife) will be present and will monitor the work process.The infant's axillary temperature, blood oxygen saturation percentage, infant heart rate, pain and maternal anxiety will be measured at 30, 60 and 90 minutes after the onset of skin contact. Intervention 2: Control group: Immediately after birth, the baby will be placed on the maternal abdomen, and dried, and the Apgar scores will be determined. If conditions will be appropriate for the skin-to-skin contact (SSC), the cord will be cut off after 3 minutes, and the head and back should be covered with a warm towel. The infant's axillary temperature, the saturation pressure oxygen (SPo2), and the heart rate (HR) will be measured using a mercury thermometer and a pulse oximeter, respectively. The maternal pain and anxiety will be evaluated on a visual analog scale, then, SSC is uninterrupted, and the baby will be placed on the mom's chest, (Baby's head between breasts), and then SSC will begin. This contact will continue for at least one hour. In this group,a midwife does skin contact. The infant's axillary temperature, blood oxygen saturation percentage, infant heart rate, pain and maternal anxiety will be measured at 30, 60 and 90 minutes after the onset of skin contact. 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 will be decided in the future.
public Seyedeh Saeedeh Mousavi
School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street
Tehran Iran (Islamic Republic of) ۱۹۹۶۷۱۳۸۸۳ +98 21 4365 1807 Saideh.musavi@yahoo.com Iran University of Medical Sciences scientific Seyedeh Saeedeh Mousavi
School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street
Tehran Iran (Islamic Republic of) ۱۹۹۶۷۱۳۸۸۳ +98 21 4365 1807 mousavi.ss@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Single pregnancy and wanted pregnancy Natural delivery Lack of obstetrics complications (such as gestational hypertension, gestational diabetes, prolonged or suspended labor, and fetal distress) No history of maternal medical diseases or mental illnesses Birth weight ≥2500 One minute Apgar score ≥ 7 No medical problem and abnormality in the baby Gestational age ≥ 37 weeks No manual removal of placenta No analgesia during labor No prohibition of breastfeeding Having a lady companion no limit no limit Female Maternal unwillingness to participate in the research Third-or fourth-degree perineal lacerations Postpartum hemorrhage Five minute Apgar score < 7 Anything interrupting skin-to-skin contact Rehabilitation Rehabilitation Intervention group: Immediately after birth, the baby will be placed on the maternal abdomen, and dried, and the Apgar scores will be determined. If conditions will be appropriate for the skin-to-skin contact (SSC), the cord will be cut off after 3 minutes, and the head and back should be covered with a warm towel. The infant's axillary temperature, the saturation pressure oxygen (SPo2), and the heart rate (HR) will be measured using a mercury thermometer and a pulse oximeter, respectively. The maternal pain and anxiety will be evaluated on a visual analog scale, then, SSC is uninterrupted, and the baby will be placed on the mom's chest, (Baby's head between breasts), and then SSC will begin. This contact will continue at least one hour. In the intervention group, the mother's companion will perform SSC, while the researcher (midwife) will be present and will monitor the work process.The infant's axillary temperature, blood oxygen saturation percentage, infant heart rate, pain and maternal anxiety will be measured at 30, 60 and 90 minutes after the onset of skin contact. Control group: Immediately after birth, the baby will be placed on the maternal abdomen, and dried, and the Apgar scores will be determined. If conditions will be appropriate for the skin-to-skin contact (SSC), the cord will be cut off after 3 minutes, and the head and back should be covered with a warm towel. The infant's axillary temperature, the saturation pressure oxygen (SPo2), and the heart rate (HR) will be measured using a mercury thermometer and a pulse oximeter, respectively. The maternal pain and anxiety will be evaluated on a visual analog scale, then, SSC is uninterrupted, and the baby will be placed on the mom's chest, (Baby's head between breasts), and then SSC will begin. This contact will continue for at least one hour. In this group,a midwife does skin contact. The infant's axillary temperature, blood oxygen saturation percentage, infant heart rate, pain and maternal anxiety will be measured at 30, 60 and 90 minutes after the onset of skin contact. Mother's pain. Timepoint: Before intervention, 30, 60 and 90 minutes after beginning skin to skin contact. Method of measurement: Visual Analogue Scale (VAS). Infant temperature. Timepoint: Before intervention, 30, 60 and 90 minutes after beginning skin to skin contact. Method of measurement: Mercury thermometer. Infant heart rate. Timepoint: Before intervention, 30, 60 and 90 minutes after beginning skin to skin contact. Method of measurement: Pulse Oximeter device. Percentage of oxygen saturation of the infant's blood. Timepoint: Before intervention, 30, 60 and 90 minutes after beginning skin to skin contact. Method of measurement: Pulse Oximeter device. Mother's anxiety. Timepoint: Before intervention, 30, 60 and 90 minutes after beginning skin to skin contact. Method of measurement: Visual Analogue Scale (VAS). Iran University of Medical Sciences Approved 2020-03-15 Ethics committee of Iran University of Medical Sciences ّّFifth floor, Headquarters., Iran University of Medical Sciences., Hemmat Highway between Chamran and Sheikh Fazlullah Tehran Tehran Iran (Islamic Republic of)