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IRCT20221220056872N1 IRCT 2023-01-22 Babol University of Medical Sciences The effect of foot reflexology on the volume and composition of breast milk inmothers of premature infants admitted to the neonatal intensive care unit The effect of foot reflexology on the volume and composition of breast milk inmothers of premature infants admitted to the neonatal intensive care unit 2023-02-01 anticipated 74 Complete https://irct.ir/trial/67512 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: People will be included in the study if they are eligible based on the entry criteria and after obtaining written informed consent. Due to the fact that the subjects of the study do not enter the study at the same time, and the researchers cannot predict in advance which group each person who enters the study will belong to. To allocate the target group to one of the two study groups (two groups A and B), block randomization method with six blocks will be used. Then the participants will be assigned to one of two groups 1-control 2-intervention according to the block randomization protocol (produced by Random Allocation Software) with a ratio of 1:1:1, in a way that the researcher cannot predict. In which intervention group is the next person placed? Concealment of random allocation refers to the method used to perform a random sequence on the participants in the study, so that the assigned group is not known before the allocation of the individual. Without hiding the random sequence, there is a possibility of revealing the random sequence, which ultimately weakens the randomization process. Therefore, it is necessary to make a decision to accept or reject participation in the study first and complete the informed consent form and then the participants are assigned to each of the groups. Different methods can be used to hide random allocation. In this study, the method of sealed opaque envelopes with a random sequence will be used. Based on the sample size of this research, a number of opaque envelopes (in order to make the contents of the envelopes unclear) were prepared and each random sequence was created. It is recorded on a card and the cards are placed in the envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the allocated group of that participant will be revealed. More about this source textSource text required for additional translation information Send feedbackSide panels. N/A Condition 1: Breast feeding. Condition 2: Breastfeeding status of mothers. Intervention 1: Intervention group: Foot reflexology includes general reflex (preparation, heating and stimulation) and special reflex (massage of pituitary, breast and solar points) for 20 minutes for both legs and 10 minutes for each leg during seven consecutive days. Seven sessions are held daily. 30 minutes after the end of reflexology, milking starts from each breast for 15 minutes. Intervention 2: Control group: The control group are mothers who will only be taught routine breastfeeding by the researcher (Master's student). Out of 37 mothers of premature babies in the first group (control group), sampling is done around 11:30. Milk is expressed from each breast for 15 minutes by an electric milking machine in the presence of a researcher (Master's student) and measured in milliliters in a graduated container, and the volume of milk is recorded with the mother's name, baby's name, time, day and date of milking. . 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 In case of official approval of the Research and Technology Vice-Chancellor of Babol University of Medical Sciences
public Fatemeh Norouzi Nodehi
Department of Nursing, Faculty of Nursing and Midwifery,Babol University of Medical Sciences,Ganj Afroz Road,Babol,Mazandaran
Babol Iran (Islamic Republic of) 4841849533 +98 11 3474 1827 yasamannorouzi456@gmail.com Babol University of Medical Sciences scientific Parvin Aziznejad
- Babol - Ganj Afroz Road - Babol University of Medical Sciences - Faculty of Nursing and Midwifery - Department of Nursing
babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11 3219 0181 aziznejadroshan@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Mother's willingness to participate in the research Willingness to breastfeed Intrauterine age of the baby 28 to 34 weeks 8- Written order Written order The doctor is based on the permissibility of breastfeeding by the mother The mother must be primiparous, that is, she does not have a previous pregnancy that even leads to abortion no limit no limit Female Cessation of breastfeeding due to the clinical conditions of the infants Discharge of the infant during the intervention Death of the infant Mother's unwillingness to continue participating in the study Absence of the mother even for one day during the seven days of the intervention Mothers with postpartum depression Having skin problems on the mother's foot such as an injury, wound or tumor or mass on the mother's foot to perform reflexology Consumption of milk-enhancing compounds, cigarettes and drugs or anticonvulsant and antipsychotic drugs by the mother Mother suffering from diseases that prohibit breastfeeding Use of contraceptive methods effective on breastfeeding The use of mothers who have therapeutic diets and vegetables P92 O92.5 Feeding problems of newborn Suppressed lactation Other Other Intervention group: Foot reflexology includes general reflex (preparation, heating and stimulation) and special reflex (massage of pituitary, breast and solar points) for 20 minutes for both legs and 10 minutes for each leg during seven consecutive days. Seven sessions are held daily. 30 minutes after the end of reflexology, milking starts from each breast for 15 minutes. Control group: The control group are mothers who will only be taught routine breastfeeding by the researcher (Master's student). Out of 37 mothers of premature babies in the first group (control group), sampling is done around 11:30. Milk is expressed from each breast for 15 minutes by an electric milking machine in the presence of a researcher (Master's student) and measured in milliliters in a graduated container, and the volume of milk is recorded with the mother's name, baby's name, time, day and date of milking. . Breast milk volume. Timepoint: At the beginning of the study and on the seventh day after the reflexology intervention. Method of measurement: Expressed milk is measured in milliliters in a graduated container. Total protein and albumin in breast milk. Timepoint: At the beginning of the study and on the seventh day after the reflexology intervention. Method of measurement: Biochemical index of milk total protein and albumin with a spectrophotometric device made in England model (Unico 9344) with the accuracy of mg/dL, for all samples centrifuged by Clement device (2000 available in the laboratory) total protein and albumin of breast milk It will be recorded based on standard registration instructions and based on mg/dL. Fat (cholesterol and triglyceride) in breast milk. Timepoint: At the beginning of the study and on the seventh day after the reflexology intervention. Method of measurement: Biochemical index of milk cholesterol and triglycerides with spectrophotometric device made in England model (Unico 9344) with the accuracy of mg/dL, for all samples centrifuged by Clement device (2000 available in the laboratory) breast milk cholesterol and triglycerides It will be recorded based on standard registration instructions and based on mg/dL. Calcium in breast milk. Timepoint: At the beginning of the study and on the seventh day after the reflexology intervention. Method of measurement: Biochemical index of milk calcium with a spectrophotometric device made in England, model (Unico 9344) with the accuracy of mg/dL, for all samples centrifuged by the Clement device (2000 available in the laboratory) of breast milk calcium based on standard registration instructions and based on It will be recorded on a mg/dL basis. Babol University of Medical Sciences Approved 2022-12-12 Ethics Committee of Babol University of Medica l Science Department of Nursing, Faculty of Nursing and Midwifery,Babol University of Medical Sciences,Ganj Afroz Road,Babol,Mazandaran Babol Mazandaran Iran (Islamic Republic of)