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IRCT20221204056708N1 IRCT 2022-12-22 Shiraz University of Medical Sciences Investigating the effect of massage based on Iranian medicine on the level of bilirubin in newborns Investigating the effect of massage based on Iranian medicine with almond oil on bilirubin in full-term and pre-term infants with hyperbilirubinemia referred to the phototherapy departments of Shiraz hospitals. 2023-01-21 anticipated 160 Complete https://irct.ir/trial/67198 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, the stratified permutation block method will assign neonates to two control and intervention groups in two subgroups. Based on the size of the sample and the number of groups, and considering the two subgroups to create the correct ratio of sample allocation to the blocks, eight blocks of 20 will be allocated in the random allocation list (according to the two subgroups, ten items per subgroup). We will prepare the random allocation list with online software. N/A Neonatal jaundice, unspecified. Intervention 1: Intervention group: Massage based on Iranian medicine with almond oil. We massage the neonates in 3 stages for 15 minutes. 5 minutes for each step. In the first step: We put the neonate on his abdomen. We will massage the neonate from the top of the head to the neck and upside down. Then back and forth movements from the neck to the shoulders. Then, from the upper back to the waist. Then we massage from the shoulder to the fingertips back and forth (on both hands). Then massage from the thigh to the ankle in a back-and-forth motion, which we do on both legs. In the second step, we put the baby to sleep in the open arch position. We perform bending and straightening movements of the right arm, left arm, right leg, and left leg (folded or flexed) in each step (opening and closing the hand or leg) movement in ten seconds, which together take one minute will be done. It will take about 5 minutes for both hands and both feet. In the third step, we will repeat the first step. These steps are taught to the mother to perform. Intervention 2: Control group: In this group, we perform only routine care, such as phototherapy. 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 The release schedule for this has not yet been formulated
public Bahar Morshed-Behbahani
Zand St.
Shiraz Iran (Islamic Republic of) 7193613119 +98 71 3647 4251 morshe_b@yahoo.com Shiraz University of Medical Sciences scientific Bahar Morshed-Behbahani
Zand St.
Shiraz Iran (Islamic Republic of) 7193613119 +98 71 3647 4251 morshe_b@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Birth age over 34 weeks Hyper bilirubin Hospitalization in the photo therapy department no limit no limit Both Underlying medical conditions medicine consumption sensitivity to almond oil P59 Neonatal jaundice from other and unspecified causes Treatment - Other Treatment - Other Intervention group: Massage based on Iranian medicine with almond oil. We massage the neonates in 3 stages for 15 minutes. 5 minutes for each step. In the first step: We put the neonate on his abdomen. We will massage the neonate from the top of the head to the neck and upside down. Then back and forth movements from the neck to the shoulders. Then, from the upper back to the waist. Then we massage from the shoulder to the fingertips back and forth (on both hands). Then massage from the thigh to the ankle in a back-and-forth motion, which we do on both legs. In the second step, we put the baby to sleep in the open arch position. We perform bending and straightening movements of the right arm, left arm, right leg, and left leg (folded or flexed) in each step (opening and closing the hand or leg) movement in ten seconds, which together take one minute will be done. It will take about 5 minutes for both hands and both feet. In the third step, we will repeat the first step. These steps are taught to the mother to perform. Control group: In this group, we perform only routine care, such as phototherapy. Mean serum bilirubin level. Timepoint: Daily , from the time of admission until three days. Method of measurement: Venous blood sampling and measurement of bilirubin level. The number of photo therapy hours. Timepoint: Discharge time. Method of measurement: Photo therapy hours recorded in the file. Shiraz University of Medical Sciences Approved 2022-12-20 The Ethics Committee of the Schools of Nursing and Midwifery, Management and Medical Information - S Karimkhan Zand Street, Namazi Square Shiraz Fars Iran (Islamic Republic of)