Protocol summary

Summary
Goal: Compare between effect of lilt of Koran and lalaie on newborn physiologic indicators Design: at first check hearing by startle reflex. Then assesse in every 3 group, 40 minute in every day, in 1 week. Every 3 group match some demographic variables as: sex-BW-BT. More over uses of co-variance test. O2 sat assess by puls-oximetry. 1 group (control) gives normal care and silent head phone, 1 group (intervention1) gives normal care and lilt of Koran (1-83 yasin) 20 minute, 1 group (intervention2) gives normal care and lilt of lalaie20 minute. Before intervention, 10 min after, 20 min after start and 40 min after start HR and O2 SAT will assess. Cases: 60 preterm newborn those have included criteria randomize in 3 groups. All of them in 1 week and every day 40 min will assess. Control group receive off headphone, 1 group tilt of Koran and other lalaie. Inclusion criteria: preterm newborn admitted in NICU; no history of maternity anomaly, CHD, deafness, mother addiction to cigarette or alcohol; no use of ventilator; no use of narcotic or sedative drug; Muslim parents Exclusion criteria: during study diagnosis of abnormality -parent dissatisfaction; newborn agitation during intervention-discharge before 1 week- dead and missing data. Interventions: lalaie- lilt of Koran-normal situations Variables: O2saturation, heart rate

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014101819566N2
Registration date: 2014-11-08, 1393/08/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-11-08, 1393/08/17
Registrant information
Name
Mohsen Hojat
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 715433054
Email address
hojat@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
jahrom university of medical sciences
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Koran (yasin) and Lullaby music listening on physiological indicators of premature neonates admitted in Motahari hospital of Jahrom
Public title
Comparison of the effect of Koran (yasin) and Lullaby music listening on physiological indicators of premature neonates admitted in Motahari hospital of Jahrom
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: preterm newborn admited in NICU; no history of maternity anomaly, CHD, deafness, mother adiction to cigarette or alcohol; no use of ventilator; no use of narcotic or sedative drug; muslim parents Exclusion criteria: during study diagnosis of abnormality parent dissatisfaction; newborn agitation during intervation discharge befor 1 week dead and missing data.
Age
From 1 day old to 1 month old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
jahrom university medical sciences
Street address
jahrom-fars-iran
City
jahrom
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
1879

Health conditions studied

1

Description of health condition studied
Preterm newborn
ICD-10 code
P07.3
ICD-10 code description
Other preterm infants

Primary outcomes

1

Description
O2 saturation
Timepoint
Before intervantion, 10 min after intervention, 20 min after, 40 min after
Method of measurement
Puls oxymetry

2

Description
Mean heart rate
Timepoint
Before intervantion, 10 min after intervention, 20 min after and 40 min after
Method of measurement
Central monitoring

Secondary outcomes

1

Description
Pain
Timepoint
Before intervention and 40 min after
Method of measurement
visual pain scale

Intervention groups

1

Description
control group:give head phone with out soundgive normal care in ward
Category
Other

2

Description
intervention1: give 20 minute lilt of koran 1-83 Yasin- Tartil male sound
Category
Other

3

Description
intervention 2: give 20 miute lilt of Lalie by male sound
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ostad Motahari hospital
Full name of responsible person
Mohsen Hojat
Street address
Ostad Motahari hospital, Motahari aven., Jahrom
City
Jahrom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
jahrom university of medical sciences
Full name of responsible person
mohsen hojat
Street address
motahari aven-jahrom-jahrom universit medical sciences
City
Jahrom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
jahrom 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
jahrom university of medical sciences
Full name of responsible person
Mohsen Hojat
Position
Faculty member, PhD student of nursing
Other areas of specialty/work
Street address
Ostad Motahari hospital, Motahari aven., Jahrom
City
Jahrom
Postal code
Phone
+98 71 5426 0608
Fax
+98 71 5434 1508
Email
mohsenhojat@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
jahrom university of medical sciences
Full name of responsible person
Mohsen Hojat
Position
Faculty member, PhD student
Other areas of specialty/work
Street address
Ostad Motahari hospital, Motahari aven., Jahrom
City
Jahrom
Postal code
Phone
+98 71 5426 0608
Fax
+98 71 5434 1508
Email
mohsenhojat@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
jahrom univercity of medical sciences
Full name of responsible person
Mohsen Hojat
Position
Faculty member
Other areas of specialty/work
Street address
Ostad Motahari hospital, Motahari aven., Jahrom
City
Jahrom
Postal code
Phone
+98 71 5434 1501
Fax
+98 71 5434 1508
Email
mohsenhojat@yahoo.com
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
Loading...