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IRCT20221220056884N1 IRCT 2023-04-28 Kerman University of Medical Sciences A comparative study of abdominal and field massage on physiological indicators, weight gain, and digestive function of preterm infants A comparative study of abdominal and field massage on physiological indicators, weight gain, and digestive function of preterm infants admitted to neonatal intensive care units: A randomized controlled clinical trial 2023-02-20 anticipated 90 Complete https://irct.ir/trial/67702 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Premature babies in the NICU department who have the conditions to enter the study, using the random block method with the size of blocks of 3 and 9, including (abdominal massage group, field massage and control group) with a 1:1:1 allocation ratio in one of the groups Intervention and control will be placed. Allocation sequence will be determined using the computer program www.Random.org by a person not involved in the selection of the samples, Blinding description: The evaluation of the outcome will be made by someone who is blinded to the groups. N/A Preterm newborn. Intervention 1: Intervention group 1: The masseur in the intervention group gives her baby abdominal massage for 15 minutes at a certain time (9:00 a.m. and 9:00 p.m.) on five consecutive days (as trained). Intervention 2: Intervention group 2: The masseur gives her neonetals a field massage for 15 minutes at a certain time (9:00 am and 9:00 pm) on five consecutive days (as trained).Field massage is such that each massage will consist of 3 phases of 5 minutes and a total of 15 minutes, in the first and third phase, the baby will be placed on the stomach and the massage will be performed as follows: 1) from the top of the head to the neck and vice versa, 2) from the neck to the shoulders and vice versa, 3) from the upper back to the waist and vice versa, 4) from the shoulder to the hand and then in the reverse direction in both hands, 5) from the thigh to the ankle leg and then in the reverse direction on both legs. In each of the mentioned areas, 12 movements of 5 seconds will be performed. In the second phase, the baby will be in the vault position and the passive movements of flexion and extension of the arms and legs separately and both legs together will be performed in 5 stages of one minute, each stage will include 6 movements of 10 seconds. Takes. Intervention 3: Control group: Newborns in the control group will receive the routine NICU care. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is still no plan to develop a program for sharing the data. According to the above sampling data time, the study will be completed by that time.
public Golnoush Motamedi
Kerman University of Medical Sciences, Pardizeh, Haft Bagh
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5207 golnoush.motamedi@gmail.com Kerman University of Medical Sciences scientific Sedigheh Khodabande Shahraki
School of Nursing and Midwifery, Kerman University of Medical Sciences, Haft-bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5207 mitra.khodabandeh@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) The baby being in their first 48 hours after birth Feeding through a nasogastric tube - French 6 or 8 5th-minute Apgar being 7 or higher Gestational age between 30 to 34 weeks Absence of severe respiratory distress Weight between 1000 and 1750 grams No need for ventilation Absence of mother's addiction 2 days 28 days Both Cleft palate and lip Any prohibition for massage All preterm infants with congenital abnormalities such as congenital heart disease, gastrointestinal tract abnormalities, hypoxic injury, respiratory failure, current or past history of necrotizing enterocolitis, suspected or confirmed sepsis Recent abdominal surgery P07.3 Preterm [premature] newborn [other] Treatment - Other Treatment - Other Treatment - Other Intervention group 1: The masseur in the intervention group gives her baby abdominal massage for 15 minutes at a certain time (9:00 a.m. and 9:00 p.m.) on five consecutive days (as trained). Intervention group 2: The masseur gives her neonetals a field massage for 15 minutes at a certain time (9:00 am and 9:00 pm) on five consecutive days (as trained).Field massage is such that each massage will consist of 3 phases of 5 minutes and a total of 15 minutes, in the first and third phase, the baby will be placed on the stomach and the massage will be performed as follows: 1) from the top of the head to the neck and vice versa, 2) from the neck to the shoulders and vice versa, 3) from the upper back to the waist and vice versa, 4) from the shoulder to the hand and then in the reverse direction in both hands, 5) from the thigh to the ankle leg and then in the reverse direction on both legs. In each of the mentioned areas, 12 movements of 5 seconds will be performed. In the second phase, the baby will be in the vault position and the passive movements of flexion and extension of the arms and legs separately and both legs together will be performed in 5 stages of one minute, each stage will include 6 movements of 10 seconds. Takes Control group: Newborns in the control group will receive the routine NICU care. Physiological indicators. Timepoint: Before the intervention, after the intervention. Method of measurement: Saadat Monitoring Machine. Weight gain. Timepoint: Before the intervention, after the intervention. Method of measurement: Seca scale made by Persia factory. Digestive function. Timepoint: Before the intervention, after the intervention. Method of measurement: Syringe. personal Approved 2023-02-27 Ethics Committee of Kerman University of Medical Sciences Haft Bagh Alavi, Pardizeh, Kerman University of Medical Sciences Kerman Kerman Iran (Islamic Republic of)