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IRCT20130202012346N2 IRCT 2018-01-05 Alborz university of Medical science comparison of the effect of massage and prone positioning on VS variation Comparison of the effect of massage and prone positioning on changes of HR & SaO2 among hospitalized preterm neonates in NICUs . 2017-07-23 anticipated 75 Complete https://irct.ir/trial/12414 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The subjects were selected through convenient sampling by drawing without replacement. With regard to 75 possible subjects’ drop , 25 subjects were assigned to each group. It was listed the number and name of the group, on each drop( Position group:1, Massage group:2, control group:3). For each infant, a sheet is drawn randomly, Blinding description: All stages of intervention will record by a Panasonic handy cam. Then, recorded films would observed and scored by a person who will blind to assignment of neonates to three different groups. To prevent bias and prejudice, this person will unaware of the group, which the neonate she will watching belonged to, so that scoring was made based on codes. N/A Condition 1: prone position. Condition 2: massage. Intervention 1: First Intervention group : Position group: Subjects will be laid on prone position for 1 hour, then during this time, the HR and SaO2 variation, will be recorded every 15 min. This intervention will be done for 5 consecutive days in a specific hour for every infant. Intervention 2: Intervention group 2nd: Massage group: After receiving massage according to Tiffany Field technique, the HR and SaO2 variation, will be recorded every 15 min, during 1 hour monitoring. This intervention will be done for 5 consecutive days in a specific hour for every infant. Intervention 3: Control group: Subject will be monitored for 5 consecutive days in a specific hour, during 1 hour without any intervention and the HR and SaO2 variation, will be recorded every 15 min. Yes - There is a plan to make this available What will be shared: Demographic information of cases include of: age, sex & weight of neonates will report in tables. When: 6 month after publish of results. To whom: Staff nurses and Master of sciences that are involve with neonates. Conditions: E-Mail request. Following the approval of the university law will apply. Where to obtain: Deputy of Research of University How to obtain: Requesting to Deputy of Research of University and doing administrative process Comments:
public Azamolmolouk Elsagh
Faulty of Nursing and Midwifery- First Golestan- South Eshteraki- Baghestan Blvd
Karaj Iran (Islamic Republic of) 3146883811 +98 26 3433 6008 a_elsagh@nm.mui.ac.ir Alborz University of Medical Science scientific Razieh Lotfi
Faulty of nursing and Midwifery- First Golestan- South Eshteraki- Baghestan Bolvared
Karaj Iran (Islamic Republic of) 3146883811 +98 26 3443 3324 razieh_lotfi@yahoo.com Alborz University of Medical Science Iran (Islamic Republic of) Iran (Islamic Republic of) Complete infant's vigilance > 2500gr 34 - 37 wk ability of breastfeeding Hospitalization more than 1 week RDS diagnosis O2 dependency The lower limit of SaO2 = 89% Haven't any touch contraindication 1 day 1 month Both <1500 gr major congenital anomalies asphyxia limb Paralysis >37 wk addiction of mother CHD and dependent disease active bleeding derm complications limb Paralysis Other Other Other First Intervention group : Position group: Subjects will be laid on prone position for 1 hour, then during this time, the HR and SaO2 variation, will be recorded every 15 min. This intervention will be done for 5 consecutive days in a specific hour for every infant. Intervention group 2nd: Massage group: After receiving massage according to Tiffany Field technique, the HR and SaO2 variation, will be recorded every 15 min, during 1 hour monitoring. This intervention will be done for 5 consecutive days in a specific hour for every infant. Control group: Subject will be monitored for 5 consecutive days in a specific hour, during 1 hour without any intervention and the HR and SaO2 variation, will be recorded every 15 min. HR. Timepoint: 1min- 15th min- 30th min- 45th min- 60th min. Method of measurement: Palse Oximetery. SaO2. Timepoint: 1min-15th min- 30th min- 45th min- 60th min. Method of measurement: palse Oximetery. Alborz university of Medical science Approved 2017-06-22 Ethics committee of Alborz University of medical Science Faculty of nursing & midwifery. First Golestan- North Esteraki- Baghestan Blvd Karaj Alborz Iran (Islamic Republic of)