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IRCT20150621022852N2 IRCT 2018-02-20 Tehran University of Medical Sciences The Effect of Massage on Neonatal Jundice in Neonatal Intensive Care Unit The Effect of Massage on Neonatal Hyperbilirubinemia in Neonatal Intensive Care Unit 2018-01-21 anticipated 64 Complete https://irct.ir/trial/29016 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of random sampling is blocking. To determine whether each child is in the control group or experience the use of the blu-ring method, it is determined by the throwing of the six-sided dice that controls or experiences from the first to the last one. To implement the blocking method, two modes A and B are considered so that the six blocks are as follows from the different types of placement of these two modes together: 1)ABAB 2)AABB 3) ABBA 4)BBAA 5)BABA 6) BAAB Then, with the throwing of six-sided dice, ten blocks of four (ten modes for the direction of 70 children) are obtained randomly according to the above conditions; each of the selected letters will be considered for children 1-42. A and B modes are also determined randomly (lottery) as controls or as experiences (eg, mode A as control and B as experience). In addition, with the throw of dice, the order of the block is specified. Draw and throw dice in the presence of a supervisor or consultant professor. Examples of dice throwing scenarios, for example, are achieved, and the following results are obtained and the assignment of samples to the experiment group and control will be based on it, Blinding description: A person who performs the Blilirubin test will be Blind to the groups. N/A Hyper bilirubinemia. Intervention 1: Intervention group:The intervention group of the newborns in the intervention group, in addition to receiving usual care, will be given massage for a period of five days, 3 times a day, and 15 minutes each time, according to the technique of the Fidel Massage. The practice of massage is taught to mothers by the trained researcher in accordance with the guidelines of the International Association of Infant Massage (IAIM). Babies will be massaged during the first day by a researcher or mother's participation. After assessing and assuring the mother's learning and mastery of massage; Mothers from the first to fifth days do their massage therapy on their babies, and their performance is monitored by the researcher in a timely and correct manner. Massage after washing and Warming the hands is done in a warm environment.Each massage is composed of 3 phases of 5 minutes and a total of 15 minutes. In the first and third phases, the baby is placed in the abdomen and the massage is done as follows: 1) from the top to the neck and vice versa, 2 ) From the neck to the shoulders and vice versa, 3) from the back to the waist and vice versa, 4) from the shoulder to the hand, then in the direction of return in both hands, 5) from the thigh to the ankle and then in the direction of return in both Leg. In the second stage, motor stimulation involves extensibility and flexion of the organs in the supine position. Intervention 2: Control group: In the control group after birth and transfer to the neonatal ward, they will be evaluated and qualified to join the study by researchers.Then, the goal of the study will explained to mothers and after obtaining consent and completing the informed consent form they will be enrolled in study. All mother will be inform about breastfeeding and jaundice. The control group will receive only routine care, such as umbilical cord care, audiometry, and vaccination. During study days control group will be assess about same study variables that will be check in intervention group. Yes - There is a plan to make this available What will be shared: Data from the study under the supervision of the scientific and practical scientist will be the study of collecting and sharing the results and raw data with full supervision. When: From the beginning of the study to the publication of the results. To whom: Researcher and supervisor of the plan and the officials of the Ethics Committee of the University Conditions: To verify the results and verify the accuracy of the documentation. Where to obtain: Must be referred to the scientific and practical planner. How to obtain: Call the scientific and practical scientist through the phone or email. Comments:
public Zeinab Shokati Mir
Nursing And Midwifery School, Tehran University Of Medical Science,Tehran Province, Tehran, District 6, Nosrat St
Tehran Iran (Islamic Republic of) 141973317 +98 21 6691 4368 sina.asadi90@yahoo.com Tehran University of Medical Sciences scientific Zeinab Shokati Mir
Nursing And Midwifery School, Tehran University Of Medical Science,Tehran Province, Tehran, District 6, Nosrat St
Tehran Iran (Islamic Republic of) 141973317 +98 21 6691 4368 sina.asadi90@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Noramal Birth Weight:2500 to 4000 grams No history of any acute congenital disorder Negative symptom or sign of Sepsis or infection 1 day 5 days Both P59.9 Neonatal jaundice, unspecifiedPhysiological jaundice (intense)(prolonged) NOS Treatment - Other N/A Intervention group:The intervention group of the newborns in the intervention group, in addition to receiving usual care, will be given massage for a period of five days, 3 times a day, and 15 minutes each time, according to the technique of the Fidel Massage. The practice of massage is taught to mothers by the trained researcher in accordance with the guidelines of the International Association of Infant Massage (IAIM). Babies will be massaged during the first day by a researcher or mother's participation. After assessing and assuring the mother's learning and mastery of massage; Mothers from the first to fifth days do their massage therapy on their babies, and their performance is monitored by the researcher in a timely and correct manner. Massage after washing and Warming the hands is done in a warm environment.Each massage is composed of 3 phases of 5 minutes and a total of 15 minutes. In the first and third phases, the baby is placed in the abdomen and the massage is done as follows: 1) from the top to the neck and vice versa, 2 ) From the neck to the shoulders and vice versa, 3) from the back to the waist and vice versa, 4) from the shoulder to the hand, then in the direction of return in both hands, 5) from the thigh to the ankle and then in the direction of return in both Leg. In the second stage, motor stimulation involves extensibility and flexion of the organs in the supine position. Control group: In the control group after birth and transfer to the neonatal ward, they will be evaluated and qualified to join the study by researchers.Then, the goal of the study will explained to mothers and after obtaining consent and completing the informed consent form they will be enrolled in study. All mother will be inform about breastfeeding and jaundice. The control group will receive only routine care, such as umbilical cord care, audiometry, and vaccination. During study days control group will be assess about same study variables that will be check in intervention group. Level of bilirubin in serum. Timepoint: in first five days of intervention. Method of measurement: Measurement of serum bilirubin levels in blood samples of patients. Tehran University of Medical Sciences Approved 2017-06-19 Ethics committee of Tehran University of Medical Sciences Poursina st,Enghelab Ave,Tehran,Iran Tehran Tehran Iran (Islamic Republic of)