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IRCT20220104053619N1 IRCT 2022-01-19 Babol University of Medical Sciences The effect of yoga on breast milk The effect of yoga on the volume and composition of breast milk in premature infants 2022-01-10 anticipated 78 Complete https://irct.ir/trial/61077 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Participants will be assigned to one of two control and intervention groups in a ratio of 1: 1. Randomization is block randomization with blocks of size of 6. According to the random block division protocol (produced by Random Allocation Software), so that the researcher can not predict Slowly the next person in which group of intervention is placed. The codes will be placed inside the matte envelopes, respectively, and with the arrival of each new person, the envelope is opened and the person's belonging to the relevant group is determined, Blinding description: In this study, due to the fact that after randomization, both mothers and researchers can not be blinded (because the type of intervention is known), so blinding can not be done in the first stage. On the other hand, measuring all the consequences in this study is objective and laboratory. Blinding will only be done for the laboratory evaluator and data analyst. N/A The effect of yoga on the volume and composition of milk of mothers with premature infants. Intervention 1: In the intervention group (yoga), 39 mothers were included in the study according to the inclusion criteria. In addition to teaching routine breastfeeding, mothers are taught yoga relaxation techniques by a yoga specialist from the first day to the sixth day in the presence of the researcher in a quiet room separate from the neonatal ward located in the gynecology clinic of Ayatollah Rouhani Hospital in Babol. It is given to include: 1- Exercising the muscles around the chest for 10 minutes while sitting on a chair 2- Asana movements while sitting on a chair for 5 minutes 3- Deep and gentle breathing with chest movements while sitting on a chair 5 minutes 4 - Relax for 25 minutes in a quiet and low light environment with a gentle song played by the laptop and lying on the floor. During the yoga intervention every day for 45 minutes for 6 The consecutive day after training is breastfeeding routine. For all mothers in the intervention group, on the first and sixth days after the end of the routine breastfeeding training class and performing the yoga relaxation technique, sampling is done between 11-12: 30 by milking with an electric breastmilk by Mami Wack, made in Germany, and the sample Our studies are selected from the second breastfeeding, which is three hours away from the first, and are measured in a non-sterile calibrated glass container by the first researcher and recorded in terms of volume in the questionnaire, and 5 ml of breast milk by The sterile syringe is taken and placed in a container containing an ice pack to be transferred to the freezer of the Biochemistry Laboratory of Babol University of Medical Sciences at -80 ° C for storage for biochemical tests. Glyceride), albumin and total protein, calcium and phosphorus with a spectrophotometer made in England, model (Unico 9344) with accurate measurement of mg / dl by a laboratory expert in the form of blind and for all samples centrifuged (by Clement 2000 available in the laboratory) according to the instructions Standard Mel Kit (Pars Azmoon made in Iran) is measured. Intervention 2: 39 mothers with inclusion criteria who are on days 4-6 after delivery, in the control group after routine breastfeeding training by a trained researcher (student) and based on a checklist in the neonatal intensive care unit Takes. The mother first washes her hands and sits on a comfortable chair in the breastfeeding room. Environmental conditions such as dimming and protecting the fabric provide comfort to the mother. An explanation of the operation of the electric breast pump in the ward is given to the mother. The first milking time after the mother wakes up is around eight o'clock in the morning. The samples of our study are selected from the second breastfeeding, which is three hours away from the first. For all mothers in the control group, sampling is done fifteen minutes after the end of the routine breastfeeding training class at eleven and fifteen minutes on the first and sixth days. Milk is milked by German Mami Vak electric milking machine with the presence of a researcher and measured in a non-sterile graduated glass container based on milliliters by the first researcher and recorded with the name of mother and baby and milking time and milk volume and direction. Laboratory examination is kept at -80 ° C in the refrigerator of the biochemistry department of Babol University of Medical Sciences. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Fatemeh Karimi
Ganj Afrooz St
Babol Iran (Islamic Republic of) 47176-47745 009832325887 karimifateme711@gmail.com Babol University of Medical Sciences scientific Fatemeh karimi
Ganj Afrooz St
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3219 9592 karimifateme711@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Maternal desire to participate in research Breastfeeding by mother Possibility of mother for breastfeeding during the day Intrauterine age below 34 weeks Written order from the doctor stating that breastfeeding is allowed by the mother To be primiparous means not to have a previous pregnancy that even leads to abortion. Mothers who spend 4-6 days after giving birth 4 days 6 days Both Anatomical problems in the breast such as nipple sagging and fissures and mastitis Smoking and addiction Taking drugs that affect milk production Mothers with active tuberculosis and AIDS Mothers who have had breast surgery Mothers who have postpartum depression or experience a life crisis or sedative. Mothers who consume lactating compounds Mothers on treatment regimens and vegetables (vegetarian). History of exercise or yoga during the last 3 months Use of effective contraceptive methods on breastfeeding N/A N/A In the intervention group (yoga), 39 mothers were included in the study according to the inclusion criteria. In addition to teaching routine breastfeeding, mothers are taught yoga relaxation techniques by a yoga specialist from the first day to the sixth day in the presence of the researcher in a quiet room separate from the neonatal ward located in the gynecology clinic of Ayatollah Rouhani Hospital in Babol. It is given to include: 1- Exercising the muscles around the chest for 10 minutes while sitting on a chair 2- Asana movements while sitting on a chair for 5 minutes 3- Deep and gentle breathing with chest movements while sitting on a chair 5 minutes 4 - Relax for 25 minutes in a quiet and low light environment with a gentle song played by the laptop and lying on the floor. During the yoga intervention every day for 45 minutes for 6 The consecutive day after training is breastfeeding routine. For all mothers in the intervention group, on the first and sixth days after the end of the routine breastfeeding training class and performing the yoga relaxation technique, sampling is done between 11-12: 30 by milking with an electric breastmilk by Mami Wack, made in Germany, and the sample Our studies are selected from the second breastfeeding, which is three hours away from the first, and are measured in a non-sterile calibrated glass container by the first researcher and recorded in terms of volume in the questionnaire, and 5 ml of breast milk by The sterile syringe is taken and placed in a container containing an ice pack to be transferred to the freezer of the Biochemistry Laboratory of Babol University of Medical Sciences at -80 ° C for storage for biochemical tests. Glyceride), albumin and total protein, calcium and phosphorus with a spectrophotometer made in England, model (Unico 9344) with accurate measurement of mg / dl by a laboratory expert in the form of blind and for all samples centrifuged (by Clement 2000 available in the laboratory) according to the instructions Standard Mel Kit (Pars Azmoon made in Iran) is measured. 39 mothers with inclusion criteria who are on days 4-6 after delivery, in the control group after routine breastfeeding training by a trained researcher (student) and based on a checklist in the neonatal intensive care unit Takes. The mother first washes her hands and sits on a comfortable chair in the breastfeeding room. Environmental conditions such as dimming and protecting the fabric provide comfort to the mother. An explanation of the operation of the electric breast pump in the ward is given to the mother. The first milking time after the mother wakes up is around eight o'clock in the morning. The samples of our study are selected from the second breastfeeding, which is three hours away from the first. For all mothers in the control group, sampling is done fifteen minutes after the end of the routine breastfeeding training class at eleven and fifteen minutes on the first and sixth days. Milk is milked by German Mami Vak electric milking machine with the presence of a researcher and measured in a non-sterile graduated glass container based on milliliters by the first researcher and recorded with the name of mother and baby and milking time and milk volume and direction. Laboratory examination is kept at -80 ° C in the refrigerator of the biochemistry department of Babol University of Medical Sciences. Determining the effect of yoga on breast milk volume in mothers of premature infants admitted to neonatal intensive care unit. Timepoint: Measurement of milk volume at the beginning of the study (first day) and the end of the study (sixth day). Method of measurement: The volume of milk is measured using milk milked by an electric milking machine in a calibrated container. Determining the effect of yoga on breast milk fat in mothers of premature infants admitted to neonatal intensive care unit. Timepoint: Measurement of breast milk fat based on the samples of the first day of the study and the sixth day of the study. Method of measurement: Cholesterol and triglyceride levels in breast milk were evaluated using a laboratory test. Determining the effect of yoga on breast milk total protein in mothers of premature infants admitted to neonatal intensive care unit. Timepoint: Measurement of breast milk total protein using milk samples on the first and sixth days of the study. Method of measurement: Using laboratory amounts of total protein in milk samples. Determining the effect of yoga on breast milk albumin in mothers of premature infants admitted to neonatal intensive care unit. Timepoint: Measurement of breast milk albumin based on the samples of the first day of the study and the sixth day of the study. Method of measurement: Study using laboratory values of albumin in milk samples of the first and sixth days. Determining the effect of yoga on breast milk calcium in mothers of premature infants admitted to neonatal intensive care unit. Timepoint: Measurement of breast milk calcium based on the samples of the first day of the study and the sixth day of the study. Method of measurement: Using laboratory values of calcium in milk samples on the first and sixth days of the study. Determining the effect of yoga on breast milk phosphorus in mothers of premature infants admitted to neonatal intensive care unit. Timepoint: Measurement of breast milk phosphorus based on the samples of the first day of the study and the sixth day of the study. Method of measurement: Using laboratory amounts of phosphorus in milk samples of the first and sixth days of the study. Determining the effect of yoga on the weight of infants admitted to the neonatal intensive care unit. Timepoint: Measure the baby's weight on the first and sixth days. Method of measurement: Measure the baby's weight using a digital scale on the first and sixth days of the study. Babol University of Medical Sciences Approved 2022-01-03 Ethics committee of Babol University of Medical Sciences Babol University of Medical Sciences،Ganj Afrooz St Babol Mazandaran Iran (Islamic Republic of)