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Effect of Classical Music and Lullaby on Physiologic Parameters and Sleep/Awake State of Hospitalized Preterm Infants in NICU

Protocol summary

Summary
purpose: determination effect of classical music and lullaby on hospitalized preterm infant's sleep/awake state improvement and physiologic parameters stability. study: RCT, crossover, not blinded, convenient sampling. Inclusion criteria: 1) infant GA in birth between 27w and 6d and 37w and 0d, 2)no congenital abnormality, no heart or neurologic disease, 3) intact hearing,4)no opiate, sedative or anticonvulsive therapy. Exclusion criteria: 1) all situation causes need for oxygen therapy or respiratory support, 2) increased infant distress or hypersensivity to intervention, 3) discharge, 4) parents refuse to continue. sample size: 72. 24 infants for 6 consecutive day in 3 situations, 2days in lullaby situation, 2 days in clossical music situation and 2 days in control situation, are observed.we have 6 groups based on transposition of situations.priority of groups were determined with randomization. outcome: increase o2 saturation, decrease HR and respiration and increase queit sleep in intervention situations.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012081510606N1
Registration date: 2012-10-08, 1391/07/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-10-08, 1391/07/17
Registrant information
Name
Parisa Rafiei
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 2248 2076
Email address
rafie_p@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2012-09-21, 1391/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Classical Music and Lullaby on Physiologic Parameters and Sleep/Awake State of Hospitalized Preterm Infants in NICU
Public title
Effect of music therapy on preterm infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1) infant GA in birth between 27w and 6d and 37w and 0d, 2)no congenital abnormality, no heart or neurologic disease, 3) intact hearing,4)no opiate, sedative or anticonvulsive therapy. Exclusion criteria: 1) all situation causes need for oxygen therapy or respiratory support, 2) increased infant distress or hypersensivity to intervention, 3) discharge, 4) parents refuse to continue.
Age
From 28 years old to 37 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
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
Tehran Universty of Medical Sciences Ethics Committee
Street address
Tehran, Keshavarz blv, Ghods st.
City
Tehran
Postal code
Approval date
2011-08-20, 1390/05/29
Ethics committee reference number
90/d/130/2598

Health conditions studied

1

Description of health condition studied
physiologic parameters and sleep/awake status
ICD-10 code
XVI
ICD-10 code description
Certain conditions originating in the perinatal period

Primary outcomes

1

Description
respiration rate
Timepoint
every 2 min, for before, simultaneous and after intervention periods
Method of measurement
respiration rate in 1 min,with observation

2

Description
blood pressure
Timepoint
every 5 min for before, simultaneous and after intervention periods
Method of measurement
with osilometric method and bedside monitoring based on mmhg

3

Description
heart rate
Timepoint
every 2 min for before, simultaneous and after intervention periods
Method of measurement
with bedside monitoring

4

Description
o2saturation
Timepoint
every 2 min for before, simultaneous and after intervention periods
Method of measurement
based on saturated Hb percentile, with pulseoximeter

5

Description
sleep/awake status
Timepoint
every 2 min for before, simultaneous and after intervention periods
Method of measurement
includ 6 stages based on Brazelton sleep/awake statuses

Secondary outcomes

empty

Intervention groups

1

Description
This study is crossover and every sample is observed one time as control and two anothrt times as intervention groups. every situation lasts for two days. intervention situations include lullaby and classical music and for every situation two days. observaton time in all situations is 40min every day.it starts 10min before music in intervention groups and continues for 20min music time and 10min after music. in lullaby situation,0.5 to 1 hr after nutrition we start observation.2 cameras record dependent variables.10 min after start, lullaby is played through 2 speakers, located at incubater corners,with 30 cm of infant's head, in 45-50 dl for 20 min.observation lasts 20 min after music..this situation for every infant includs 2 consecutive days.
Category
Other

2

Description
in classical music situation,0.5 to 1 hr after nutrition we start observation.2 cameras record dependent variables.10 min after start, classical music(Baby Mozzart) is played through 2 speakers, located at incubater corners,with 30 cm of infant's head, in 45-50 dl for 20 min.observation lasts 20 min after music. this situation for every infant includs 2 consecutive days.
Category
Other

3

Description
in control situation.every infant is observed 40 min,start 0/5 to 1 hr after nutrition.2 cameras record dependent variables.this situation for every infant includs 2 consecutive days.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hojar hospital
Full name of responsible person
Parisa Rafiei
Street address
City
Shahre Kord

2

Recruitment center
Name of recruitment center
Imam Ali hospital
Full name of responsible person
Parisa Rafiei
Street address
City
Shahre Kord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research, Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
dr azam baheiraei
Street address
Tehran, tohid sq, Faculty of nursing and midwifery, University of Tehran
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 and Midwifery, Tehran 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
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Prisa Rafiei
Position
MSc student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences , Tohid sq.
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
rafie_p@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Elaheh Amini
Position
Assistant professor
Other areas of specialty/work
Street address
Valiasr center, Emam Khomeini hospital, Dr Gharib st, Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2359
Fax
Email
amini_el88@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Khadijeh Zareii
Position
MSC
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences , Tohid sq.
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
zareiikh@tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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