A randomized design with repeated measures is to be used to explore the physiologic responses of preterm infants from 30 to 33 weeks gestation between two intrventional and one control groups to a selection of recorded Bram’s lullaby, mam's lullaby and control ambient noise in a NICU. A 15-minute session lullaby with a relatively constant rhythm, volume and pitch provided at a volume level in the low 65 dBA, 1000 Hertz is the (patterned sound) intervention used. Effects of the patterned/ambient noises measured every 5-minutes before, during, and after the sound condition of mam’s or Bram’s lullaby or ambient noise by observing oxygen saturation, heart rate, respiratory rate of randomely assigned preterm infants in the NICU in relation to a control group in which no patterned sound(only standard NICU care with ambient noise) is to be provided. Recording of 15-minute session(Bram’s lullby in low 65 dBA, 1000 Hertz) saved as a sound file in the iPod touch. Next transducers, acoustic tips and tubing and a dual headphone adapter 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. After setting up the equipment, pulse oximeter/monitor recording will be initiated. The patterned sound will be started after 10 minutes and stopped after15 minutes.The pulse oximeter/monitor recordings continued until 20 minutes after sound recording was stopped.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201210284617N3
Registration date:2012-11-13, 1391/08/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-11-13, 1391/08/23
Registrant information
Name
Mahnaz Jabraeili
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
jabraeilim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Tabriz University of Medical Sciences
Expected recruitment start date
2012-11-29, 1391/09/09
Expected recruitment end date
2013-03-18, 1391/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Selected Recorded Patterned Sound on the Physiologica Responses of Preterm Infants in the NICU , Tabriz. 2012
Public title
The Effect of Patterned Sound on the Physiologica Responses of Preterm Infants
Purpose
Prevention
Inclusion/Exclusion criteria
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.
Age
To 1 year old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences Ethics Committee
Street address
Tabriz. Golgasht street- Rsearch Center of Medical University
City
Tabriz
Postal code
977-5138947
Approval date
2012-10-11, 1391/07/20
Ethics committee reference number
5138/4/5
Health conditions studied
1
Description of health condition studied
Patterned Sound
ICD-10 code
Z00-Z99
ICD-10 code description
Health supervision and care of other healthy infant and child
Primary outcomes
1
Description
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).
2
Description
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).
3
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
N/A
2
Description
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.
Category
Treatment - Drugs
3
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra center
Full name of responsible person
Sara Moghaddam
Street address
Tabriz, College of nursing
City
Tabriz
2
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Sara Mogadam
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Tabriz University of Medical Sciences
Full name of responsible person
ِDoctor ostad rahimi
Street address
Research Council of Tabriz University of Medical Sciences, Golgasht street , Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
tabriz college of nursing
Full name of responsible person
tahmineh-sabet
Position
M.S student
Other areas of specialty/work
Street address
faculty of nursing and midwifery , shariatii street, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 71 1821 8472
Fax
Email
mlkywy_mn@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz Medical Science University , faculty of nursing and midwifery
Full name of responsible person
Mahnaz Jabraeili
Position
educator, Master of science
Other areas of specialty/work
Street address
faculty of nursing and midwifery , shariati street ,tabriz,iran
City
Tabriz
Postal code
5138947-977
Phone
+98 41 1479 6770
Fax
+98 41 1479 6969
Email
jabraeilim@tbzmed.ac.irjebreilim@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Medical Science University
Full name of responsible person
Mahnaz Jabraeili
Position
Ms, Educator
Other areas of specialty/work
Street address
Nursing and midwifery of facultuy, shariati street,Tabriz,Iran
City
Tabriz
Postal code
Phone
+98 41 1479 6969
Fax
+98 41 1479 6770
Email
jabraeilim@tbzmd.ac.irjebreilim@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)