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IRCT20200120046200N3 IRCT 2022-11-14 Iran University of Medical Sciences The effect of participation in the oral-pharyngeal administration of colostrum on anxiety of mothers of preterm infants The effect of participation in the oral-pharyngeal administration of colostrum on anxiety of mothers of preterm infants admitted to neonatal intensive care unit 2022-10-23 anticipated 148 Complete https://irct.ir/trial/66203 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible samples will be continuously included in the study, then the allocation will be done in two groups of test and control randomly using the 4-block method with placement. The random list of people is prepared through the website http://randomisation.ir. N/A The effect of participation in the oral-pharyngeal administration of colostrum on the anxiety of mothers of premature babies hospitalized in the neonatal intensive care unit. Intervention 1: Intervention group: During the first 24 hours after giving birth, the mothers of the test group deliver their expressed milk to the researcher three times a day every 4 hours during the prescribed time in the morning and evening shifts for 48 hours, and the researcher injects the expressed colostrum with a 1 ml syringe, without The head of the needle is given to the baby three times a day, in the presence of the mother and under the supervision of a newborn doctor. In this way, the tip of the syringe is placed in the baby's mouth along the right buccal mucosa and is directed to the oropharynx, and the volume of 0.1 ml is prescribed, and without removing the syringe from inside the baby's mouth, the left buccal is also 0.1 ml. ml is repeated in the mentioned method. A total of 0.2 ml is prescribed in each session. Mothers in the control group do not receive milk to feed the baby, and they express their milk and deliver it to the neonatal intensive care unit according to the department's routine when the doctor orders to start breastfeeding and feeding the baby. Intervention 2: Control group: Mothers in the control group are not given milk to feed the baby, and according to the department's routine, when the doctor orders to start breastfeeding and feeding the baby, they express their milk and deliver it to the neonatal intensive care unit. 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) 1996713883 +98 21 4365 1807 mousavi.ss@iums.ac.ir 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) 1996713883 +98 21 4365 1807 mousavi.ss@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Ages 18 years and above Willingness to breastfeed Understanding and speaking ability in Persian language Willing to manually express milk or use of a manual or electric breast pump in the first 24 hours after delivery mother's presence in the hospital during the study period Gestational age less than 32 weeks or birth weight less than 1500 grams Being NPO for infant Stable vital signs for infant 18 years no limit Both Mother's suffering from psychological disorders requiring medication based on mother's self-report History of drug and psychoactive abuse Surgery or breast problems such as abscess, inverted nipple, mastitis or cancer Having diseases contrary to breastfeeding such as AIDS, active pulmonary tuberculosis Occurrence of stressful events during the study period Hospitalization of the mother after delivery in departments other than postpartum No grade 3 and 4 intraventricular hemorrhage Absence of pH less than 6 in the fifth minute after birth Absence of abnormalities in the infant based on medical records Z63.7 Other stressful life events affecting family and household N/A N/A Intervention group: During the first 24 hours after giving birth, the mothers of the test group deliver their expressed milk to the researcher three times a day every 4 hours during the prescribed time in the morning and evening shifts for 48 hours, and the researcher injects the expressed colostrum with a 1 ml syringe, without The head of the needle is given to the baby three times a day, in the presence of the mother and under the supervision of a newborn doctor. In this way, the tip of the syringe is placed in the baby's mouth along the right buccal mucosa and is directed to the oropharynx, and the volume of 0.1 ml is prescribed, and without removing the syringe from inside the baby's mouth, the left buccal is also 0.1 ml. ml is repeated in the mentioned method. A total of 0.2 ml is prescribed in each session. Mothers in the control group do not receive milk to feed the baby, and they express their milk and deliver it to the neonatal intensive care unit according to the department's routine when the doctor orders to start breastfeeding and feeding the baby. Control group: Mothers in the control group are not given milk to feed the baby, and according to the department's routine, when the doctor orders to start breastfeeding and feeding the baby, they express their milk and deliver it to the neonatal intensive care unit. Maternal anxiety. Timepoint: Before the intervention, 24 hours after the intervention. Method of measurement: State Trait Anxiety Inventory(STAI). Iran University of Medical Sciences Approved 2022-10-04 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)