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IRCT20210501051142N3 IRCT 2022-08-02 Arak University of Medical Sciences Comparison of three methods of foot massage, kangaroo care and standard care on bilirubin level and physiological indicators Comparison of three methods of foot massage, kangaroo care and standard care on bilirubin level and physiological indicators of term neonates with physiological jaundice 2022-10-02 anticipated 84 Complete https://irct.ir/trial/64881 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Infants are assigned to two intervention groups and one control group based on the randomization sequence that will be generated in advance, which is unpredictable and its arrangement is completely random. To allocate the samples, the block randomization method with the size of 3 blocks will be used, so that by using the software for generating random numbers in the block method, a randomization sequence will be generated according to the sample size required for the three groups. First, all the modes in which the 3 letters A, B and C can be put together in blocks of 3 are generated, then a block is randomly selected by placing it among the blocks and the layout pattern in that block will be used to allocate infants. Finally this block will be placed in the main container and another block will be selected again. Blocks of 3 will all be in the same container. All this will be done with software called Sealed Envelope. With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups that the researcher will not be able to predict which group the next person will be in, Blinding description: The data analyzer will not know how the samples are placed in the intervention and control groups. Other people in the study will be aware of this placement. N/A Physiological jaundice. Intervention 1: Intervention group1: Babies in the reflexology group receive massage in the respective specific area, in such a way that the baby is placed on the bed in a quiet and bright room lying on his back and completely relaxed, and the researcher washes his hands to prevent infection and after Warming up, first apply olive oil from Ladan Talai company made in Iran to reduce friction and then test the olive oil on the child's forearm (in order to rule out a possible allergy to olive oil) and start massaging the specific area. researcher holds the baby's heel with his left hand and massages the relevant area with his right thumb in a controlled and dedicated manner. The frequency of massage for each baby for the reflexology intervention group will be once a day for 15 minutes (30 minutes in total for both legs of the baby). Intervention 2: Intervention group2: In the babies of the kangaroo care group by the KMC method, the mother with the kangaroo care clothes is placed on the folding bed in a semi-sitting position (40-60 degrees) or lying down and the naked baby , wearing only a diaper and a hat, will be placed between the mother's breasts with the help of a nurse. This KMC method will last for 30 minutes, so that it will be done at least five times a day (every 3 hours) in the morning, evening and night shifts during breastfeeding. Intervention 3: Control group: Like the two intervention groups, they are treated with phototherapy. In this group there is no intervention (reflexology, KMC). Yes - There is a plan to make this available What will be shared: Only the part of the data related to the original outcome will be able to be shared. When: since the winter of 2023 To whom: Researchers and students in this field Conditions: Control of bilirubin level and physiological indicators of full-term infants with physiological jaundice Where to obtain: Vice chancellor for education and research, Arak university of medical sciences How to obtain: These documents will be available on the website of Arak university of medical sciences Comments:
public Mahbobeh Sajadi
University complex of the Great prophet, Basij square, Sardasht.
Arak Iran (Islamic Republic of) 3819693345 009886341735057 golmehrsherafati@gmail.com Arak University of Medical Sciences scientific Mahbobeh Sajadi
University complex of the Great prophet, Basij square, Sardasht.
Arak Iran (Islamic Republic of) 3819693345 009886341735057 golmehrsherafati@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) No underlying, congenital and infectious disease Term infants (gestational age equal to or greater than 37 weeks) Birth weight over 2,500 grams Exclusive breastfeeding 1 day 21 days Both Infant parents' unwillingness to participate in the study The presence of problems in the soles of the feet (edema, tissue damage, skin infection, skin rashes, fractures) Need for blood transfusion Other Other Other Intervention group1: Babies in the reflexology group receive massage in the respective specific area, in such a way that the baby is placed on the bed in a quiet and bright room lying on his back and completely relaxed, and the researcher washes his hands to prevent infection and after Warming up, first apply olive oil from Ladan Talai company made in Iran to reduce friction and then test the olive oil on the child's forearm (in order to rule out a possible allergy to olive oil) and start massaging the specific area. researcher holds the baby's heel with his left hand and massages the relevant area with his right thumb in a controlled and dedicated manner. The frequency of massage for each baby for the reflexology intervention group will be once a day for 15 minutes (30 minutes in total for both legs of the baby). Intervention group2: In the babies of the kangaroo care group by the KMC method, the mother with the kangaroo care clothes is placed on the folding bed in a semi-sitting position (40-60 degrees) or lying down and the naked baby , wearing only a diaper and a hat, will be placed between the mother's breasts with the help of a nurse. This KMC method will last for 30 minutes, so that it will be done at least five times a day (every 3 hours) in the morning, evening and night shifts during breastfeeding. Control group: Like the two intervention groups, they are treated with phototherapy. In this group there is no intervention (reflexology, KMC). Bilirubin level. Timepoint: Every 24 hours. Method of measurement: The baby's bilirubin is taken by capillary inside the capillary tube and sent to the hospital laboratory and measured by photometric method according to the routine of the newborn department and is continuously collected and recorded in the form. Arak University of Medical Sciences Approved 2022-07-02 Ethics committee of Arak university of medical sciences Arak university of medical sciences, Basij Sq., Sardasht region Arak Markazi Iran (Islamic Republic of)