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IRCT20180519039709N1 IRCT 2018-08-06 Babol University of Medical Sciences Comparision the effect of kangaroo mother care (KMC) with Field massage on serum bilirubin level in full term newborns with hyperbilirubinemia Comparision the effect of kangaroo mother care (KMC) with Field massage on serum bilirubin level in full term newborns with hyperbilirubinemia admitted for phototherapy 2018-08-06 anticipated 90 Complete https://irct.ir/trial/31335 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this clinical trial, 90 term neonates with hyperbilirubinemia will be select and randomly divided into two intervention and one control groups.Randomization starts from a random point from a random number table and For a number of interventions, the intervention group and the control group are used a random permutation method, So that random numbers 0-4 for random permutation A B {(control B) (intervention A)} and Random numbers 5-9 are used for the random permutation B A {(Intervention A) (Control B)}. N/A Hyperbilirubinemia. Intervention 1: Intervention group: kangaroo mother care (KMC):In the intervention group, in addition to standard phototherapy, KMC Will be apply by the mother. The mother after wearing a special gown laid on a folding bed, while the naked infant (wearing only a diaper and a hat) will be place between her breasts by a nurse. During hospitalization, KMC will be apply for 30-45 min at least five times a day in the morning, afternoon, and night. Intervention 2: Intervention group: Field massage : Massage Will be done with the soft parts of the fingers of both hands with light pressure by the researcher using field technique. Massage duration was 15 minutes, and include three steps each lasting five minutes, according to the same study. During the first and final stages, the infant is placed in prone position, and each minute one of the following areas is massage: A) 12 massage moves (every five seconds one move) from head downwards (both sides of the face to neck and reversely); B) 12 massage motions from the neck to the shoulders and reversely; C) 12 massage moves from the upper back down to the waist and reversely; D) 12 massage moves from the thighs down to the ankles and reversely; E) 12 massage motions from the shoulders to the wrists and reversely, in the middle phase, the infant was put in supine position and six extension and flexion moves were done (10 seconds for each) in the right arm, left arm, right leg, left leg, and both legs. Intervention 3: Control group: the newborns in the control group (age and weight similar to the intervention groups)is recived standarde phototherapy and only breastfeed by the mother, whereas KMC and massage do not apply. 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 Because of the dissertation's completion
public Parvin Aziznejadroshan
Keshavarz St, Ghanj afroz Ave
Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11321995926 aziznejadroshan@yahoo.com Babol University of Medical Sciences scientific Parvin aziznejadroshan
Keshavarz St, Ghanj afroz St
Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11321995926 aziznejadroshan@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Gestational age 37-42 weeks Birth weight 2500-4000 g Apgar score from first to fifth minutes above 7 Receiving phototherapy for hyperbilirubinemia Breast feeding No drug to reduce bilirubin Age older 48 hours after birth Bilirubin 15-20 mgr/dl 2 days 28 days Both ABO and Rh incompatibility, Possitivecoombs, hemolysis subgaleal hemorrhage, cephal hematoma, purpura Congenital anomaly infection Bile duct and digestive tract obstruction lack of glucose-6-phosphate dehydrogenase, Doubtful newborn to TORCH syndrom P59.9 Neonatal jaundice, unspecified Treatment - Other Treatment - Other N/A Intervention group: kangaroo mother care (KMC):In the intervention group, in addition to standard phototherapy, KMC Will be apply by the mother. The mother after wearing a special gown laid on a folding bed, while the naked infant (wearing only a diaper and a hat) will be place between her breasts by a nurse. During hospitalization, KMC will be apply for 30-45 min at least five times a day in the morning, afternoon, and night. Intervention group: Field massage : Massage Will be done with the soft parts of the fingers of both hands with light pressure by the researcher using field technique. Massage duration was 15 minutes, and include three steps each lasting five minutes, according to the same study. During the first and final stages, the infant is placed in prone position, and each minute one of the following areas is massage: A) 12 massage moves (every five seconds one move) from head downwards (both sides of the face to neck and reversely); B) 12 massage motions from the neck to the shoulders and reversely; C) 12 massage moves from the upper back down to the waist and reversely; D) 12 massage moves from the thighs down to the ankles and reversely; E) 12 massage motions from the shoulders to the wrists and reversely, in the middle phase, the infant was put in supine position and six extension and flexion moves were done (10 seconds for each) in the right arm, left arm, right leg, left leg, and both legs. Control group: the newborns in the control group (age and weight similar to the intervention groups)is recived standarde phototherapy and only breastfeed by the mother, whereas KMC and massage do not apply. Neonatal blood bilirubin level. Timepoint: Measurement of Bilirubin level at 24, 48, and 72 h after phototherapy and Intervention. Method of measurement: Measurement of serum bilirubin levels in neonatal blood samples. Babol University of Medical Sciences Approved 2018-04-28 Ethics committee of Babol University of Medical Sciences Babol University of Medical Sciences, Keshavarz St., Ganj Afrooz road, Baboll Bobol Mazandaran Iran (Islamic Republic of)