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IRCT20181216042011N1 IRCT 2019-02-15 Kerman University of Medical Sciences Comparing the effect of music and mother`s lullaby on physiological responses and sleep of preterm infants Comparing the effect of music and mother`s lullaby on physiological responses and sleep of preterm infants in NICU 2019-02-20 anticipated 60 Complete https://irct.ir/trial/36417 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sample will be selected from preterm infants according to inclusion criteria,then by using of random numbers table, infants will be placed in three groups. On Saturdays and Sundays, eligible babies will be placed in recording mother's lullaby group, on Mondays and Tuesdays will be placed in live mother's lullaby group , and on Wednesdays and Thursdays, the baby will not be subjected to any intervention. N/A Physiological responses. Intervention 1: Intervention group1:The First intervention group shall be held in their mother's tender embrace and by using the headphones, the recorded lullaby sounds in Persian will be set for twenty minutes every evening. Physiologic responses of infants will be documented in check list 10 min before intervention, during intervention and 20 min after intervention. for evaluating the baby's sleep status, researcher will be completed the sleep questionnaire on the first day of intervention and the 14th day. Intervention will be performed once a day for 14 days. Intervention 2: Intervention group 2:The second intervention group shall be held in their mother's tender embrace and the mother will sing lullaby for twenty minutes. Physiologic responses of infants will be documented in check list 10 min before intervention, during intervention and 20 min after intervention. for evaluating the baby's sleep status, researcher will be completed the sleep questionnaire on the first day of intervention and the 14th day. Intervention will be performed once a day for 14 days. Intervention 3: Control group: In this group, infant shall be held in their mother's tender embrace for 20 min without playing music for them.Physiologic responses of infants will be documented in check list 10 min before intervention, during intervention and 20 min after intervention. for evaluating the baby's sleep status, researcher will be completed the sleep questionnaire on the first day of intervention and the 14th day. Intervention will be performed once a day for 14 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is relied on secrecy
public Monirsadat Nematollahi
No. 1, Sheykh Ahmadkafi Aven. ,Kerman
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3252 6603 m.nematolahi@kmu.ac.ir Kerman University of Medical Sciences scientific Monirsadat Nematollahi
Campus of Kerman university of medical sciences ,Haft bagh Alavi highway
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3252 6603 m.nematolahi@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Gestational age more than 30 weeks Lack of congenital anomalies Lack of mechanical ventilation 1 day 28 days Both having hear difficulties receive sedatives three hours before intervention Other Other Other Intervention group1:The First intervention group shall be held in their mother's tender embrace and by using the headphones, the recorded lullaby sounds in Persian will be set for twenty minutes every evening. Physiologic responses of infants will be documented in check list 10 min before intervention, during intervention and 20 min after intervention. for evaluating the baby's sleep status, researcher will be completed the sleep questionnaire on the first day of intervention and the 14th day. Intervention will be performed once a day for 14 days. Intervention group 2:The second intervention group shall be held in their mother's tender embrace and the mother will sing lullaby for twenty minutes. Physiologic responses of infants will be documented in check list 10 min before intervention, during intervention and 20 min after intervention. for evaluating the baby's sleep status, researcher will be completed the sleep questionnaire on the first day of intervention and the 14th day. Intervention will be performed once a day for 14 days. Control group: In this group, infant shall be held in their mother's tender embrace for 20 min without playing music for them.Physiologic responses of infants will be documented in check list 10 min before intervention, during intervention and 20 min after intervention. for evaluating the baby's sleep status, researcher will be completed the sleep questionnaire on the first day of intervention and the 14th day. Intervention will be performed once a day for 14 days. Arterial oxygen saturation. Timepoint: Before, during and after intervention. Method of measurement: Pulseoximetery. Sleep. Timepoint: The first and the 14th day of intervention. Method of measurement: BISQ questionnare. Heart rate. Timepoint: Before, during and after intervention. Method of measurement: Cardiopulmonary Monitoring. Kerman University of Medical Sciences Approved 2018-11-13 Ethics committee of Kerman University of Medical Sciences ,Medical University Campus,Haft-Bagh Highway Kerman Kerman Iran (Islamic Republic of)