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IRCT20161210031328N11 IRCT 2020-01-06 Arak University of Medical Sciences Comparison of the effect of reflexology and body massage on physiological parameters and bilirubin levels in neonates under photo therapy Comparison of the effect of foot reflexology and body massage on physiological parameters and bilirubin levels in neonates under photo therapy 2019-12-21 anticipated 51 Complete https://irct.ir/trial/44148 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants were individually divided into three groups of first intervention (reflexology), second intervention (body massage) and control group using blocked randomization. In this study, dice will be considered as a randomization tool. For making sequences, "A" letter will be assigned to the first group, "B" letter will be assigned to the second group, and the "C" letter will be assigned to the third group. Participants will not know allocation of samples to interventions and control groups, Blinding description: Data analyzer will not know how individuals are assigned to the interventions and control groups. N/A Jaundice. Intervention 1: First intervention group: Intervention will performed in a quiet, bright room, on the bed, and in a position where the infant is lying back and quite relaxed. The researcher holds the baby's heel with his left hand and gently massage the area in each leg for 15 minutes (a total of 30 minutes for both legs) with his right hand. The intervention will done once a day and olive oil will be used to facilitate massage. Intervention 2: Second intervention group: In this group, massage begins with the touch of the lower extremity and from the ankle (except soles of the feet) to the knee and groin. The umbilical region will massaged rotatly . The chest and back will massaged with both hands.The baby's hands will massaged rotatly from the arm to the fingers. The palms, cheeks and lips are also gently massaged with the index finger. Massages for each infant will be once daily for 10-15 minutes. Intervention 3: Control group: routine care. Yes - There is a plan to make this available What will be shared: Part of data, such as information on the main outcome can be shared. When: 12 months after the publishing of the results. To whom: Researchers in academic and scientific institutions. Conditions: Scientific purposes. Where to obtain: Zahra Jazayeri za.jazayeri48@gmail.com How to obtain: 2 to 3 working days. Comments:
public Zahra Jazayeri
Arak University of Medical Sciences, Basij Sq., Sardasht Region
Arak Iran (Islamic Republic of) 3819693345 +98 86 3417 3505 za.jazayeri48@gmail.com Arak University of Medical Sciences scientific Zahra Jazayeri
Arak University of Medical Sciences, Basij Sq., Sardasht Region
Arak Iran (Islamic Republic of) 3819693345 +98 86 3417 3505 za.jazayeri48@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) No underlying, congenital and infectious diseases Term infants (gestational age equal to or greater than 35 weeks) Birth weight over 2,500 grams Exclusive breastfeeding no limit no limit Both Infant parents' unwillingness to participate in the study P59.9 Neonatal jaundice, unspecified Treatment - Other Treatment - Other Other First intervention group: Intervention will performed in a quiet, bright room, on the bed, and in a position where the infant is lying back and quite relaxed. The researcher holds the baby's heel with his left hand and gently massage the area in each leg for 15 minutes (a total of 30 minutes for both legs) with his right hand. The intervention will done once a day and olive oil will be used to facilitate massage. Second intervention group: In this group, massage begins with the touch of the lower extremity and from the ankle (except soles of the feet) to the knee and groin. The umbilical region will massaged rotatly . The chest and back will massaged with both hands.The baby's hands will massaged rotatly from the arm to the fingers. The palms, cheeks and lips are also gently massaged with the index finger. Massages for each infant will be once daily for 10-15 minutes. Control group: routine care Percentage of arterial oxygen saturation (O2 saturation). Timepoint: Before intervention and one day after intervention. Method of measurement: cardio set ARDP 10 vital signs monitoring system (made in Iran). Heart rate. Timepoint: Before intervention and one day after intervention. Method of measurement: cardio set ARDP 10 vital signs monitoring system (made in Iran). Respiratory rate. Timepoint: Before intervention and one day after intervention. Method of measurement: hs43 chronometer (made in China). Bilirubin level. Timepoint: Before intervention and one day after intervention. Method of measurement: Serum bilirubin (wrist venous blood sample) measured by photometry. Arak University of Medical Sciences Approved 2019-10-13 Ethics committee of Arak University of Medical Sciences Arak University of Medical Sciences, Basij Sq., Sardasht Region Arak Markazi Iran (Islamic Republic of)