Among infants hospitalized in the neonatal intensive care unit, excessive noise is correlated with increases in heart rate, increase in respiratory rate, and decrease in oxygen saturation. Lullaby is an appropriate auditory stimulation for preterm infants. It is a kind of developmental supportive care and reduces stress responses in autonomic, motor and state systems and neurobehavioral function provide by appropriate infant stimulations. Study assesses effects of lullaby on preterm infants᾿ physiologic parameters. In a randomized control trail and cross over study, in year 2014, 40 premature infants who admitted to the NICU of Vali Asr hospital, Tehran and had inclusion criteria of this study, were randomly assigned to two groups: control group and lullaby group, and observed for three dependent variables; oxygen saturation levels, heart rate, respiration rate. Mother's lullaby was played for experimental group via speaker. The volume range was 50-60 db. The infants in the control group received no intervention. Only variables recorded each infant was considered as the control group. For two consecutive days in each of the control and intervention groups were studied. The observation took 40 minutes each day during which the heart rate and Sao2 was recorded every two minute using pulse oximeter and the respiratory rate was counted every 2 minutes for the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201501296316N5
Registration date:2015-02-17, 1393/11/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-17, 1393/11/28
Registrant information
Name
Zahra Daneshvar Ameri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
daneshvz@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-11-16, 1393/08/25
Expected recruitment end date
2015-01-15, 1393/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Mother's Lullaby on physiological parameters of premature infants
Public title
The Effects of Mother's Lullaby on premature infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1-Gestational age infants at birth based on first trimester ultrasound and LMP between 28 weeks and 36 weeks and 6 days. 2- The birth weight infants between 1500 and 2500 g. 3-Infants with confirmed auditory health with OAE. 4-Any congenital abnormality or neural and cardiac disease has been confirmed on the basis of the records is not. 5-Physiological and behavioral effects of drugs such as anticonvulsants, sedatives and narcotics receive. 6-The family history is not retarded person. 7-Infants are not undergoing phototherapy or mechanical ventilation. 8-Infants, are enrolled from the third day after birth.
Exclusion criteria: 1-Each change of status of infants in the days leading to the need for respiratory support. 2-Creation of symptoms of stress and intolerance on the part of nursing interventions include apnea, mottling, flashing, bradycardia, decreased blood oxygen saturation below 80% for more than 2 minutes, uncontrollable crying, hiccups, hypotonia and ... 3- hyperbilirubinemia that need for blood exchange. 4- Discourage parents from continuing to participate in the study. 5- Discharge early infant
Age
From 7 months old to 9 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Tehran University of Medical Sciences
Street address
No.43, 16th Azar st. Keshavarz blvd.
City
Tehran
Postal code
Approval date
2014-11-09, 1393/08/18
Ethics committee reference number
9111451012-125032
Health conditions studied
1
Description of health condition studied
Physiological parameters of premature infants
ICD-10 code
P90-96
ICD-10 code description
Other disorders originating in the perinatal period
Primary outcomes
1
Description
Heart rate
Timepoint
Ten minutes before the lullaby, 20 minutes during lullaby and 10 min after the lullaby
Method of measurement
Puls oximeter
2
Description
Respiratory rate
Timepoint
Ten minutes before the lullaby, 20 minutes during lullaby and 10 min after the lullaby
Method of measurement
Observed and count abdominal movements
3
Description
Arterial oxygen saturation
Timepoint
Ten minutes before the lullaby, 20 minutes during lullaby and 10 min after the lullaby
Method of measurement
Puls oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Experimental group: Mother's lullaby voice recordings is played for twenty minutes
Category
Other
2
Description
control: without intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU Valiasr(aj) hospital
Full name of responsible person
Mis. Abron
Street address
Valiasr hospital, Keshavarz blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research Faculty of Nursing Midwifery
Full name of responsible person
Dr. Ziba Taghizadeh
Street address
Faculty of Nursing Midwifery, Tohid square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research Faculty of Nursing Midwifery
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
Faculty of Nursing and Midwifery, Tehran
Full name of responsible person
Elham Shafiei
Position
Masters of students NICU
Other areas of specialty/work
Street address
No.15, Dameshgh st. Felestin st.
City
Tehran
Postal code
Phone
+98 21 8892 7594
Fax
Email
elham68shafiei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran
Full name of responsible person
Elham Shafiei
Position
Masters of students NICU
Other areas of specialty/work
Street address
No.15, Dameshgh st. Felestin st.
City
Tehran
Postal code
Phone
+98 21 8892 7594
Fax
Email
Elham68shafiei@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran
Full name of responsible person
Elham Shafiei
Position
Masters of students NICU
Other areas of specialty/work
Street address
No.15, Dameshgh st. Felestin st.
City
Tehran
Postal code
Phone
Fax
Email
elham68shafiei@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)