The effect Voice of the Holy Quran on the duration of transition from gavage to first oral feeding and vital signe at premature newborns hospitalized in neonatal intensive care unit
The effect of listening to the holy quran on the physiological responses of of premature infants admitted to the neonatal intensive care unit
Design
Premature infants with inclusion criteria were randomly assigned to control and intervention groups
Settings and conduct
The play of Quranic voices for preterm infants will be performed in the neonatal intensive care unit.
Participants/Inclusion and exclusion criteria
1. Gestational age less than 32 weeks
2. Physiological stability over the last 24 hours
3. Birth weight proportional to the gestational age
4. The APGAR score of 7 and more in the first and fifth minutes of birth
5. Lack of family history of deafness or mental retardation
6. Non-underlying disease
7. Getting full breastfeeding or formula through oral gavage and oral feeding
8. Lack of disease, except premature
9. Being Muslim
Exclusion criteria
1-Abnormal physiological responses
2-Neonatal need for any medical intervention
3-Impairment in infant's consciousness
4-Incidence of digestive problems such as necrotizing enterocolitis
5-Unwillingness of the infant's parents
Intervention groups
Playing Quranic Voice for Intervention Group
Do not distribute the Quran to the control group
Main outcome variables
Improve vital signs
Reduce the feeding time of the gavage
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20170620034653N3
Registration date:2018-06-19, 1397/03/29
Registration timing:retrospective
Last update:2018-06-19, 1397/03/29
Update count:0
Registration date
2018-06-19, 1397/03/29
Registrant information
Name
Zahra Tayebi Myaneh
Name of organization / entity
Qazvin University of medical science
Country
Iran (Islamic Republic of)
Phone
+98 28 3224 8614
Email address
z.tayebi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect Voice of the Holy Quran on the duration of transition from gavage to first oral feeding and vital signe at premature newborns hospitalized in neonatal intensive care unit
Public title
The effect of the Quran's voice on the formation of oral nutrition in premature infants admitted to the intensive care unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age less than 32 weeks
Physiological stability over the last 24 hours
The APGAR score of 7 and more in the first and fifth minutes of birth
Getting full breastfeeding or formula through oral gavage and oral feeding
Lack of disease, except premature
Being Muslim
Lack of family history of deafness or mental retardation
Exclusion criteria:
Abnormal physiological responses
Unwillingness of the infant's parents
Incidence of digestive problems such as necrotizing enterocolitis
Neonatal need for any medical intervention
Impairment in infant's consciousness
Age
From 1 day old to 2 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Easy sampling will be done. After selecting samples, their random assignment will be done in two groups using the card method inside the bag.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
esfahan University of Medical Sciences
Street address
Esfahan University of Medical Sciences, Shahid Bahonar Blvd., Qazvin, Iran. Iran
City
Esfahan
Province
Isfehan
Postal code
14756-33641
Approval date
2015-05-22, 1394/03/01
Ethics committee reference number
IR.mui.REC.1394.3.470
Health conditions studied
1
Description of health condition studied
Duration of feeding from gavage to first oral nutrition in premature infants
ICD-10 code
p07
ICD-10 code description
Disorders related to short gestation and low birth weight, not elsewhere classified
Primary outcomes
1
Description
Vital Signs - Duration of the passage from feeding to the tube to oral feeding-weighing
Timepoint
Physiological responses including heart rate, respiratory rate, arterial oxygen saturation, mean arterial pressure and temperature were recorded in three stages, every 10 minutes; immediately before the intervention, during the intervention (minutes 10 and 20 after intervention) And 10 minutes after the end of the intervention.
Method of measurement
Using a monitoring device
Secondary outcomes
1
Description
Weight gain in premature baby
Timepoint
The completion time of the study
Method of measurement
Weighing using scales
Intervention groups
1
Description
Intervention group: The Voice of the Holy Qur'an was performed at 45 dB for 20 minutes at three times before feeding at first, middle and end of the evening shift, and after that, the nutrition begins. This is done until the baby reaches her first full oral feeding.
Category
Rehabilitation
2
Description
Control group: Premature babies who do not hear the Quran's voice
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alborz Educational and treatment center (NICU)
Full name of responsible person
Zahra Tayebi
Street address
Alborz Hospital, Valiasr Street, Karaj
City
Alborz
Province
Alborz
Postal code
1475633641
Phone
+98 28 3224 8614
Fax
+98 21 4441 5966
Email
tayebi.medical@gmail.com
Web page address
http://www.qums.ac.ir/Portal/Home/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Amir Pymani
Street address
Qazvin university of medical science, Bahonar Bolvar, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
1475633641
Phone
+98 28 3224 8614
Fax
+98 21 4441 5966
Email
tayebiz@qumc.ac.ir
Web page address
http://www.qums.ac.ir/Portal/Home/
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Tayebi Myaneh
Position
دانشجوی پرستاری
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Qazvin.
City
Qazvin
Province
Qazvin
Postal code
00000000
Phone
+98 28 3224 8614
Fax
+98 28 3336 2090
Email
z.tayebi@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Tayebi Myaneh
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Qazvin.
City
Qazvin
Province
Qazvin
Postal code
1475633641
Phone
+98 28 3224 8614
Fax
+98 28 3336 2090
Email
z.tayebi@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Tayebi Myaneh
Position
student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Qazvin.
City
Qazvin
Province
Qazvin
Postal code
1475633641
Phone
+98 28 3224 8614
Fax
+98 28 3336 2090
Email
z.tayebi@qums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Details of the data are published in the form of demographic information in the article
When the data will become available and for how long
Immediately after the publication of the article
To whom data/document is available
There is no limit
Under which criteria data/document could be used
Data will be available for reference and use in other studies.
From where data/document is obtainable
Send the email to the responsible author
What processes are involved for a request to access data/document