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IRCT2016080629210N1 IRCT 2016-12-19 Vice Chancellor For Research, Mashhad University Of Medical Sciences The effect of recorded maternal heart rate on sleep and Physiological Parameters in preterm infants. The effect of recorded maternal heart rate on sleep and Physiological Parameters in preterm infants. 2016-05-17 anticipated 75 Complete https://irct.ir/trial/23545 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive. N/A Premature infant. Intervention 1: Group I: Control group: Infants receive no intervention in this group and they will be monitored in terms of dependent variables for 40 minutes. The headphone will be placed on the infants' ears for 40 minutes, but no sound will be played. Intervention 2: Group II: Placebo: The recorded sound of another person's heartbeats will be played at 50 dB intensity for infants through headphones for 20 minutes. Intervention 3: Group III: intervention: The recorded sound of mother's heartbeats will be played at 50 dB intensity for infants through headphones for 20 minutes.
public Zahra Yazdani
Faculty of Nursing and Midwifery
Mashhad Iran (Islamic Republic of) +98 51 3859 1511 yazdaniz931@mums.ac.ir; yazdani.zahra.sh64@gmail.com Mashhad University Of Medical Sciences scientific Dr Ahmad Shah Farhat
Faculty of Nursing and Midwifery
Mashhad Iran (Islamic Republic of) +98 51 3859 1511 FARHATA@mums.ac.ir Mashhad University Of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: the infant must have spontaneous breathing and needs no mechanical ventilation; parents should be willing and consent to participate in the study; birth weight over 1000 g , no congenital abnormalities; lack of hearing problems in newborns; 28 to 34 weeks of gestational age; lack of clear infection; no maternal addiction. Exclusion criteria: need for assisted mechanical ventilation during the intervention; unwillingness of parents to continue to participate in the project; Grade 3 and 4 intraventricular hemorrhage; history of alcohol and coffee consumption; successive apnea; incidence of seizures in newborns; hearing problems; intrauterine growth restriction (IUGR); anemia with hemoglobin≤ 10 g/dL(hemoglobin less or equal to 10 grams per deciliter) 7 months 8 months Both P07 Disorders related to short gestation and low birth weight, not elsewhere classified Other Other Other Group I: Control group: Infants receive no intervention in this group and they will be monitored in terms of dependent variables for 40 minutes. The headphone will be placed on the infants' ears for 40 minutes, but no sound will be played. Group II: Placebo: The recorded sound of another person's heartbeats will be played at 50 dB intensity for infants through headphones for 20 minutes. Group III: intervention: The recorded sound of mother's heartbeats will be played at 50 dB intensity for infants through headphones for 20 minutes. The duration of deep sleep. Timepoint: After intervention. Method of measurement: Ales doctor tools. Respiratory rate. Timepoint: Q 5 minute from 10 minutes before intervention until 10 minutes after intervention. Method of measurement: Observation. Heart rate. Timepoint: Q 1 minute from 10 minutes before intervention until 10 minutes after intervention. Method of measurement: Monitor. Oxygen saturation. Timepoint: Q 1 minute from 10 minutes before intervention until 10 minutes after intervention. Method of measurement: Monitor. Vice Chancellor For Research, Mashhad University Of Medical Sciences Approved 2016-05-09 Ethics Committee Of Mashhad University Of Medical Science Daneshgah Street mashhad Iran (Islamic Republic of)