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IRCT20090405001788N20 IRCT 2018-11-19 Iran University of Medical Sciences Effect of sound reduction management on preterm neonate’ stress in NICU Effect of sound reduction management on preterm neonate’ stress in NICU 2018-07-06 anticipated 90 Complete https://irct.ir/trial/31881 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. N/A Assess of level of preterm neonate' stress. Intervention 1: Intervention group: For assessing the effect of sound reduction management on preterm neonate’ stress interventions for 3-4 weeks to reducing noise take place that it contain a combination of educational programs, reducing alarms of equipment and phone and doors sound, transfer neonates to incubator and teaching parents from time of admit about reducing noise. 2 weeks after intervention programs, sampling for saliva cortisol of preterm neonate in intervention group take place. Sampling for all infants 48-72 hours after birth and at 9-10 AM by sterile catheter, collecting in captive tube and will store in -20 temperature until analyzing. Samples will take for each neonate 3 times in 3 consecutive days. Samples for measuring cortisol will analysis by CLIA method. Sampling will do according to available samples and all neonates that admit to ward during study will assess. Due to the property of research community and difference of development level of neonates (gestational age 26-32, 32-36), A6 variable is base of planning study as Randomized block design. Intervention 2: Control group: Samples in control group before doing interventions for reducing sound will take routine care and sampling will done for them like intervention group with same condition. Yes - There is a plan to make this available What will be shared: Data coding will done 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 and other researchers. Conditions: Systematic review and meta analysis or secondary analysis citation. Where to obtain: Leili Borimnejad , borimnejad.l@iums.ac.ir How to obtain: After sending request by academic email, we will send them data files up to one week. Comments:
public Dr. Leili Borimnejad
School of Nursing and Midwifery, Rashid Yassemi,Valiasr
Tehran Iran (Islamic Republic of) 1996713883 +98 21 8888 2886 borimnejad.l@iums.ac.ir Iran University of Medical Sciences scientific Leili Borimnejad
School of Nursing and Midwifery, Rashid Yassemi,Valiasr
Tehran Iran (Islamic Republic of) 1996713883 +98 21 8888 2886 borimnejad.l@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Neonate born with gestational age 26-36 week. Neonate with birth weight 1000-2500 gr. Neonate admit to NICU at birth. At least one hour before sampling painful procedure wouldn’t carry out for infant. 2 days 3 days Both Infant take sedative during study. Addicted mother Neonate with congenital abnormality on birth. Behavior N/A Intervention group: For assessing the effect of sound reduction management on preterm neonate’ stress interventions for 3-4 weeks to reducing noise take place that it contain a combination of educational programs, reducing alarms of equipment and phone and doors sound, transfer neonates to incubator and teaching parents from time of admit about reducing noise. 2 weeks after intervention programs, sampling for saliva cortisol of preterm neonate in intervention group take place. Sampling for all infants 48-72 hours after birth and at 9-10 AM by sterile catheter, collecting in captive tube and will store in -20 temperature until analyzing. Samples will take for each neonate 3 times in 3 consecutive days. Samples for measuring cortisol will analysis by CLIA method. Sampling will do according to available samples and all neonates that admit to ward during study will assess. Due to the property of research community and difference of development level of neonates (gestational age 26-32, 32-36), A6 variable is base of planning study as Randomized block design. Control group: Samples in control group before doing interventions for reducing sound will take routine care and sampling will done for them like intervention group with same condition. Preterm neonate' stress. Timepoint: second to third days of birth. Method of measurement: Measuring level of saliva cortisol of samples. Iran University of Medical Sciences Approved 2018-10-25 Ethics committee of Iran University of medical Seinces Hemmat Highway Tehran Tehran Iran (Islamic Republic of)