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IRCT20180508039587N1 IRCT 2018-07-03 Iran University of Medical Sciences The effect of Gentle Human Touch during endotracheal suctioning on procedural pain response in preterm infant The effect of Gentle Human Touch during endotracheal suctioning on procedural pain response in preterm infant admitted to neonatal intensive care units. 2018-06-22 anticipated 40 Complete https://irct.ir/trial/31617 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Blinding description: The baby's face is captured for pain scoring during the intervention, and without naming the baby by the codes given to the infants, they are scored by the unawar assessor. The analyst is also unaware of the work routine. N/A The effect of Gentle Human Touch during endotracheal suctioning on procedural pain response in preterm infant. Intervention 1: Intervention group:To evaluate the effect of Gentle Human Touch during endotracheal suctioning on procedural pain response in preterm infant,A total of 40 neonates with entry criteria and written consent from their parents are included in the study, which is used as a cross-over design.The intervention is performed by the researcher in a Gentle Human Touch in the infants during suctioning. Will be filmed up to 30 seconds after the intervention, and the heart rate changes and arterial oxygen saturation will be recorded from the monitor.Premature Infant Pain Profile (PIPP) is used to measure neonatal pain and the pain score is recorded. The pain score is compared with the score of the recorded pain from non-interventional items. Intervention 2: Control group: Each neonate is considered as its control. In this study, crossover design is used.Intervention and non intervention for each newborn are determined randomly. Yes - There is a plan to make this available What will be shared: After Data coding in order to keep confidentiality of the participants in the research. When: The end of sampling till six month after article publishing. To whom: Ethical,reviewer and editorial committees,researchers. Conditions: Systematic review and meta analysis or secondary analysis citation . Where to obtain: Soroor Parvizi, parvizi.s@iums.ac.ir How to obtain: After sending request by academic email,we will send them data files up to one week. Comments:
public Parvizi Soroor
Iran university,Yasemi Rashid Ave.,Valie Asr Ave.Tehran Town
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1000 parvizi.s@iums.ac.ir Iran University of Medical Sciences scientific Parvizi Soroor
Iran university,Yasemi Rashid Ave.,Valie Asr Ave.Tehran Town
Tehran Iran (Islamic Republic of) 1996713883 +98 21 4365 1000 parvizi.s@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Hospitalization in the neonatal intensive care unit The gestational age between 27-34 weeks The birth weight is 1200 grams and higher Having a tube in the trachea The need for mechanical ventilation Not getting sedation or anesthetic four hours before the intervention Not having skin disease and any skin contact disorder Not to be exposed to any painful activity at least one hour before the intervention The absence of congenital anomalies 1 day 28 days Both Changing the clinical condition of the baby, such as sudden death of the baby or need for cardiopulmonary resuscitation A sudden need for sedation or anesthetic intracranial hemorrhage higher than degree II, Need to install a chest tube Having seizures Other Other Intervention group:To evaluate the effect of Gentle Human Touch during endotracheal suctioning on procedural pain response in preterm infant,A total of 40 neonates with entry criteria and written consent from their parents are included in the study, which is used as a cross-over design.The intervention is performed by the researcher in a Gentle Human Touch in the infants during suctioning. Will be filmed up to 30 seconds after the intervention, and the heart rate changes and arterial oxygen saturation will be recorded from the monitor.Premature Infant Pain Profile (PIPP) is used to measure neonatal pain and the pain score is recorded. The pain score is compared with the score of the recorded pain from non-interventional items. Control group: Each neonate is considered as its control. In this study, crossover design is used.Intervention and non intervention for each newborn are determined randomly. Pain score in Premature Infant Pain Profile. Timepoint: Measurement of pain 30 seconds before suctioning without intervention and with intervention. Measuring pain in 30 seconds after suctioning with intervention and without intervention.Comparison of pain score at these times occurs. Method of measurement: Premature Infant Pain Profile. Iran University of Medical Sciences Approved 2017-12-08 Ethics committee of Iran University of Medical Sciences Iran university,Yasemi Rashid Ave.,Valie Asr Ave.Tehran Town Tehran Tehran Iran (Islamic Republic of)