The Effect of Holly Quran Recitation on physiologic responses of premature infants in neonatal intensive care unit, Shahid Akbarabadi treatment & education center, 2009
Background: Investigators have demonstrated that providing appropriate complementary and alternative therapy is necessary to developmental outcomes in preterm infants and pleasant sound of holly Quran recitation can be used as a useful and effective procedure to decrease the anxiety and affects on physiological and neurobehavioral functioning in patients. The aim of this research is to study effects of holly Quran recitation on physiological responses in premature infants. Materials and methods: In a double blind randomized control trail, 120 premature infants who will be admitted to the NICU of Shahid Akbarabadi hospital in Tehran, and have inclusion criteria of this study, will randomly assigned to two groups: control group and holly Quran recitation group, and will be observed for three dependent variables; oxygen saturation levels, heart rate and respiration rate. Intervention will be including 20 minutes recitation of Yusuf Quranic chapters, by Shahhat Mohammad Anvar sound that will be played for experimental group via headphone on the morning shift. The volume range will be 50-60 db. Two groups will be observed by monitor for physiological responses from 10 minutes before to 10 minutes after intervention and will be recorded before and 10,20,30 minutes after the beginning of intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138806172324N3
Registration date:2010-06-24, 1389/04/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-24, 1389/04/03
Registrant information
Name
Maryam Keshavarz
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1813
Email address
keshavarz@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Nursing and Midwifery, Iran University of Medical Sciences
Expected recruitment start date
2009-07-23, 1388/05/01
Expected recruitment end date
2009-09-21, 1388/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Holly Quran Recitation on physiologic responses of premature infants in neonatal intensive care unit, Shahid Akbarabadi treatment & education center, 2009
Public title
The Effect of Holly Quran Recitation on physiologic responses of premature infants in neonatal intensive care unit, Shahid Akbarabadi treatment & education center, 2009
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Iranian neonate with gestational age 28-36 weeks, birth weight over 1500 gr, 1 and 5-minute APGAR scores from 7 to 10, breast feeding, hearing confirmed by startle reflex, no documentation of hyper responsiveness to the sound, clinically stable infant that are appropriate for gestational age (AGA) and having no operative delivery, anomalies associated with neurological problems, undergoing mechanical ventilation, phototherapy, congenital abnormalities, symptomatic sepsis, acute illness, intraventricular hemorrhage, receiving medications such as Phenobarbital or oxygen and history of drug abuse in mother. Exclusion criteria: hyper responsiveness to the music such as hiccup, facial grimace, finger splay, clenched fingers, crying, vomiting, and heart rate over 200 per min, oxygen saturation lower than 80%, any need to handling or nursing intervention and difficulty in recording of physiological responses.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
School of Nursing and Midwifery, Iran University of Medical Sciences
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasami St. Valiasr Ave, P.P. Box: 19395-4798
City
Tehran
Postal code
19964
Approval date
empty
Ethics committee reference number
1323577
Health conditions studied
1
Description of health condition studied
physiologic responses of premature infants
ICD-10 code
P07.3
ICD-10 code description
Other preterm infants
Primary outcomes
1
Description
improving in physiologic responses of premature infants
Timepoint
every 10 minute
Method of measurement
by monitor
Secondary outcomes
empty
Intervention groups
1
Description
Holly Quran Recitation
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbarabadi treatment & education center
Full name of responsible person
Maryam Keshavarz
Street address
Molavi Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasami St. Valiasr Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Nursing and Midwifery, Iran 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
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
MSc in midwifery - academic member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasami St. Valiasr Ave
City
Tehran
Postal code
19964
Phone
+98 21 8247 1406
Fax
+98 21 8879 3805
Email
keshavarz@iums.ac.ir , m_keshir@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
MSc in midwifery - academic member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasami St. Valiasr Ave
City
Tehran
Postal code
19964
Phone
+98 21 8247 1406
Fax
+98 21 8879 3805
Email
Keshavarz@iums.ac.ir , m_keshir@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
MSc in midwifery - academic member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasami St. Valiasr Ave
City
Tehran
Postal code
19964
Phone
+98 21 8247 1406
Fax
+98 21 8879 3805
Email
Keshavarz@iums.ac.ir , m_keshir@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)