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IRCT201501073706N24 IRCT 2015-03-05 Research deputy of Tabriz University of Medical Sciences The effect of reflexology on breast milk of women with premature hospitalized newborns The effect of reflexology on breast milk of women with premature hospitalized newborns: a randomized control trial 2015-03-06 anticipated 74 Complete https://irct.ir/trial/3815 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Breast feeding. Intervention 1: Intervention group: reflexology on the breast, solar plexus and pituitary points on the feet for 20 minutes (10 minutes on each foot), once a day for seven days. Intervention 2: control group: reflexology on the eye, shoulder and back points of feet for 20 minutes (10 minutes for each foot) once a day for seven days.
public Parisa Mirzaee
Nursing & Midwifery Faculty, South Shariati Street
Tabriz Iran (Islamic Republic of) Iran +98 41 3544 6210 yoosefe.zahra@yahoo.com Tabriz University of Medical Sciences, Nursing & Midwifery Faculty scientific Sakineh Mohammad-Alizadeh Charandabi
Faculty of Nursing & Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) Iran +98 41 3479 6770 alizades@tbzmed.ac.ir Tabriz University of Medical Sciences, Nursing & Midwifery Faculty Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: lactating women who have a singleton or twin preterm infant (s) (gestational age of 28.0 to 37.0 weeks) aged 7-60 days hospitalized at the neonatal unit or neonatal intensive care unit; have willing to continue breastfeeding; have 30% or more decreased milk supply compared to the peak volume (based on maternal account) or have inability to provide adequate breast milk to meet infant nutritional needs and a neonatologist confirms the insufficient milk production; have permanent or temporary stay at the hospital during the seven days of intervention. Exclusion criteria: metabolic diseases in the infant (s); infection or sore of woman's feet; chronic systemic illness of the woman; inability to fill up the self-administered questionnaire; no Iranian nationality; occurrence of severe psychological problems for the woman such as death of a close relative in the previous 3 months; and intention to start using a drug which may have an effect on the milk production (e.g. metoclopramide, domperidone) or change dose of the drugs in the next 15 days 18 years 40 years Female P92 Feeding problems of newborn Rehabilitation Rehabilitation Intervention group: reflexology on the breast, solar plexus and pituitary points on the feet for 20 minutes (10 minutes on each foot), once a day for seven days control group: reflexology on the eye, shoulder and back points of feet for 20 minutes (10 minutes for each foot) once a day for seven days The volume of milk expressed 2 hours after the last expression and at least half an hour after the massage. Timepoint: Before intervention - on the first, fourth and seventh days of intervention. Method of measurement: Squeezing through the electric pump. Volume of breast milk expressed during 24 hours. Timepoint: Before intervention- on the first, fourth and seventh days of intervention. Method of measurement: recording on the diary by the women. Volume of breast milk substitutions given to the infant during 24 hours. Timepoint: Before intervention, on the first, fourth, and seventh days intervention. Method of measurement: using nursing report. Infant weight gain. Timepoint: before intervention- on the first, fourth and seventh intervention days. Method of measurement: newborn weighting scale with a precision of one gram. The infant's heart rate. Timepoint: before intervention, خn the first, fourth and seventh intervention days. Method of measurement: Pulse oximeter. Infant oxygen saturation. Timepoint: before intervention, on the first, fourth, seventh intervention days. Method of measurement: Pulse oximeter. Depression score of the women. Timepoint: Before intervention, the seventh day of intervention. Method of measurement: Through self-report questionnaire DASS. Anxiety score of the women. Timepoint: Before intervention, the seventh day of intervention. Method of measurement: از طریق پرسشنامه خود گزارشی DASS. Stress score of the women. Timepoint: Before intervention, the seventh day of intervention. Method of measurement: Through self-report questionnaire DASS. The proportion of infant feeding with expressed breast milk. Timepoint: seventh day of intervention. Method of measurement: The women report table and nursing reports in the infant record. Exclusive breastfeeding. Timepoint: seventh day of Intervention. Method of measurement: Nursing report and woman report. Woman satisfaction of the intervention. Timepoint: seventh day of intervention. Method of measurement: woman report. Woman satisfaction from breastfeeding. Timepoint: the seventh day of Intervention, Seven days after end of intervention. Method of measurement: woman report. Occurrence of adverse events. Timepoint: During the study. Method of measurement: woman report. Research deputy of Tabriz University of Medical Sciences Approved 2015-02-01 Ethics Committee of Tabriz University of Medical Sciences Research Deputy, 3rd floor, Centeral building No 2 , Tabriz University of Medical Sciences, Golgasht st., Tabriz, East Azarbaijan Tabriz Iran (Islamic Republic of)