The main objectives of the study:The effect of listening to the Quran on the level of cortisol changes in pregnant women undergoing cesarean section .
The effect of listening to the Quran on level of systolic and diastolic blood pressure and heart rate in pregnant women undergoing cesarean section .
Study Design: clinical trial without placebo،this Study was done on 60 pregnant women (30 intervention and 30 control ) .Sample selection is done by simple randomization. this study is done in a teaching hospital.Blinding is not done.this study is a Phase2 clinical trial.
In the intervention group, vital signs are recorded, Blood samples were taken to measure plasma cortisol.Then,pregnant women listen to Quran.
After spinal anesthesia, vital signs are recorded and blood sample of umbilical cord is taken for measuring plasma cortisol level.In the control group, all the steps are done except listening to Quran.
inclusion criteria: primigravid pregnant women;20 to 35 years old; gestational age 37-40 weeks;candidate for elective cesarean section;Muslims; An uncomplicated pregnancy, Singleton pregnancy
exclusion criteria :increasing the duration of cesarean (more than one hour);patient does not tolerate headphone; takes any sedative drug during anesthesia
The main outcome variable: cortisol changes
Secondary outcomes: systolic blood pressure , diastolic blood pressure ,heart rate
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601126243N2
Registration date:2016-03-09, 1394/12/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-09, 1394/12/19
Registrant information
Name
Shiva Rafati
Name of organization / entity
Shahed university
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 9437
Email address
rafati@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Shahed University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of listening to the Quran on the level of cortisol in pregnant women undergoing cesarean section a clinical trial study
Public title
Effects of ًQuran on pregnant mothers, stress
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: primigravid pregnant women;20 to 35 years old; gestational age 37-40 weeks;candidate for elective cesarean section;Muslims; An uncomplicated pregnancy, Singleton pregnancy
exclusion criteria :increasing the duration of cesarean (more than one hour);
The patient does not tolerate head phone ; takes any sedative drug
Age
From 20 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
simple randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University of Medical Sciences
Street address
Shahed university,in front of holy shrine of Imam Khomeni, the Persian Gulf highway
City
Tehran
Postal code
Approval date
2013-12-10, 1392/09/19
Ethics committee reference number
IR.shahed.REC.1392.29
Health conditions studied
1
Description of health condition studied
XV Pregnancy, childbirth and the puerperium
ICD-10 code
(O00-O99)
ICD-10 code description
pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
cortisol
Timepoint
before intervention and one hour after intervention
Method of measurement
blood sampling
Secondary outcomes
1
Description
diastolic blood pressure
Timepoint
before intervention and 30 minutes after intervention
Method of measurement
Sphygmomanometer , milimeter Hg
2
Description
systolic blood pressure
Timepoint
before intervention and 30 minutes after intervention
Method of measurement
Sphygmomanometer , milimeter Hg
3
Description
heart rate
Timepoint
before and 30 minutes after intervention
Method of measurement
heart rate monitoring device
Intervention groups
1
Description
intervention group:listening to Quran during 20 minutes
Category
Other
2
Description
control group :no intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mustafa Khomeini Hospital
Full name of responsible person
ُShiva Rafati
Street address
Italia street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, shahed University of Medical Sciences
Full name of responsible person
Dr kiasalari
Street address
persian Gulf highway,in front of Holy shrime of Imam Khomeini
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, shahed 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
general practitioner, Graduated from Shahed university of medical science