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IRCT201210284617N3 IRCT 2012-11-13 Research Council of Tabriz University of Medical Sciences The Effect of Patterned Sound on the Physiologica Responses of Preterm Infants The Effect of Selected Recorded Patterned Sound on the Physiologica Responses of Preterm Infants in the NICU , Tabriz. 2012 2012-11-29 anticipated 66 Complete https://irct.ir/trial/4947 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. 2 Patterned Sound. Intervention 1: Recording of15-minute session(Bram’s lullby in low 65 dBA, 1000 Hertz) saved as a sound file in the iPod touch.Next a dual headphone adapter will be used to connect two Bio-logic earphones to a 8 GB iPod touch.earphones were lined with cotton to prevent them from sticking to infant ears.The decible level transmitted from the iPod through transduer tubing was then tested using an impulse digital sound level meterto ensure maximum sound levels with a volume in the low 60s dBA and the iPod will be locked to prevent any changes in settings.Lastly, the decible level of the room will be measured near the infant’s ears within the incubator /crib.After setting up the equipment, pulse oximeter/monitor will be initiated. Intervention 2: Recording of15-minute session(mam’s lullby in low 65 dBA, 1000 Hertz) saved as a sound file in the iPod touch.Next a dual headphone will be used to connect two earphones to a 8 GB iPod touch.earphones were lined with cotton to prevent them from sticking to infants' ears.The decible level transmitted from the iPod through transduer tubing was then tested using an impulse digital sound level meterto ensure maximum sound levels with a volume in the low 60s dBA .Lastly, the decible level of the room will be measured near the infant’s ears within the incubator /crib.After setting up the equipment, pulse oximeter/monitor will be initiated. Intervention 3: control group cared under standard situation with no additional intervention observed for 45 minutes.the decible level of the room will be measured near the infant’s ears within the incubator /crib.After setting up the equipment, pulse oximeter/monitor will be initiated.
public tahmineh-sabet
faculty of nursing and midwifery , shariatii street, Tabriz, Iran
Tabriz Iran (Islamic Republic of) +98 71 1821 8472 mlkywy_mn@yahoo.com tabriz college of nursing scientific Mahnaz Jabraeili
faculty of nursing and midwifery , shariati street ,tabriz,iran
Tabriz Iran (Islamic Republic of) 5138947-977 +98 41 1479 6770 jabraeilim@tbzmed.ac.irjebreilim@yahoo.com Tabriz Medical Science University , faculty of nursing and midwifery Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: cared in cut or incubator; 30-33 week’s gestational age; no need for supported ventilation(ventilator/CPAP/NCPAP/Nasal canula) stabilised; no congenital anomalies; were not receiving pancuronium or other medication to induce muscle paralysis; normal A.B.R and had not undergone surgery. Exclusion criteria: Diagnosis ofIVH, NEC, PDA, sepsis, acute lung disease, or neonatal anemia (Hb<12gm/dL) during intervention; known maternal drug, alcohol, or illegal substance abuse; current overhead phototherapy and currently receiving medications for sedation positive BC. no limit 1 year Both Z00-Z99 Health supervision and care of other healthy infant and child N/A Treatment - Drugs Treatment - Drugs Recording of15-minute session(Bram’s lullby in low 65 dBA, 1000 Hertz) saved as a sound file in the iPod touch.Next a dual headphone adapter will be used to connect two Bio-logic earphones to a 8 GB iPod touch.earphones were lined with cotton to prevent them from sticking to infant ears.The decible level transmitted from the iPod through transduer tubing was then tested using an impulse digital sound level meterto ensure maximum sound levels with a volume in the low 60s dBA and the iPod will be locked to prevent any changes in settings.Lastly, the decible level of the room will be measured near the infant’s ears within the incubator /crib.After setting up the equipment, pulse oximeter/monitor will be initiated. Recording of15-minute session(mam’s lullby in low 65 dBA, 1000 Hertz) saved as a sound file in the iPod touch.Next a dual headphone will be used to connect two earphones to a 8 GB iPod touch.earphones were lined with cotton to prevent them from sticking to infants' ears.The decible level transmitted from the iPod through transduer tubing was then tested using an impulse digital sound level meterto ensure maximum sound levels with a volume in the low 60s dBA .Lastly, the decible level of the room will be measured near the infant’s ears within the incubator /crib.After setting up the equipment, pulse oximeter/monitor will be initiated. control group cared under standard situation with no additional intervention observed for 45 minutes.the decible level of the room will be measured near the infant’s ears within the incubator /crib.After setting up the equipment, pulse oximeter/monitor will be initiated. O2-saturation. Timepoint: 10 minutes before-15 minutes during and 20 minutes after intervention. Method of measurement: oxygen saturation will be obtained through a SAADAT monitoring system and recorded by a coder(research assistant). Heart rate. Timepoint: 10 minutes before-15 minutes during-20 minuts after intervention. Method of measurement: oxygen saturation, heart rate will be obtained through a SAADAT monitoring system and recorded by a coder(research assistant). Respiratory rate. Timepoint: 10 minutesbefore-15 minutes during-20 minutes after the intervention. Method of measurement: three chest leads attached to neonates' chest which connected by cable to monitoring system. Research Council of Tabriz University of Medical Sciences Approved 2012-10-11 Tabriz University of Medical Sciences Ethics Committee Tabriz. Golgasht street- Rsearch Center of Medical University Tabriz Iran (Islamic Republic of)