Protocol summary

Summary
This study is clinical trial to check that Sound of Quran on hemodynamic changes before induction of anesthesia affects or not? 60 patients who have Entry criteria attend in this study before study we got their permission and our entry criterian are :candidates must have an elective surgery and whose ages are between 18-60,these patients are consistent with one and two grade of American anesthesia committee who are placed under general Anesthesia more than 10 minutes.not to be adected,do not be anemic,do not have fever,do not have heart problem, do not have historic Alergy,their blood pressure do not be more than 140 and less than 60 and do not consume Anticoagulant drugs . Before induction of anesthesia,for both groups we use the same nursing care (pulse oximetery, ECG, monitoring and appropriate course of IV (500 ml crystalloid serum before anesthesia)) then we ask control group to listen to 27th and 28th of verse of Nour sorah of Quran with voice of Mr. Parhizgar by mp4 player(we do it as an intervention) and after two minutes we record hemodynamic changes of Patients.we record hemodynamic changes of Patients in case group without any intervention. The way of induction of anesthesia is the same for two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015012820856N1
Registration date: 2015-02-24, 1393/12/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-02-24, 1393/12/05
Registrant information
Name
Mohammed Khorasani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3433 6007
Email address
m_khorasani21@yahoo.com
Recruitment status
Recruitment complete
Funding source
Alborz University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Sound effects of Quran on hemodynamic changes before induction of anesthesia in Shahid Madani hospital in Karaj
Public title
Sound effects of Quran on hemodynamic changes before induction of anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1-patiantes permission; 2-range of age (18-60); 3-not to be mental illness; 4-not to be addicts; 5-elective surgery. Exclusion criteria: 1-the patients unwillingness; 2-urgent surgery ; 3-fever patient.
Age
From 18 years old to 60 years 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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Alborz University of Medical Sciences
Street address
Mahan blvd, Jahanshah city
City
baghestan-karaj
Postal code
Approval date
2012-01-25, 1390/11/05
Ethics committee reference number
2016825

Health conditions studied

1

Description of health condition studied
pationts who have elective Surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Hemodynamic changes
Timepoint
first: befor listening to Quran and second: two minutes after listening to Quran
Method of measurement
Blood pressure (mmhg with sphygmomanometer),HR(rate per min with austotoscope), pulse rate (rate per min with pulse oximetery)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: we use sound of Quran(27th and 28th of verse of Nour sorah with voice of mr.Parhizgar) by mp4 player as an intervention and in this group we recorde hemodynamic changes(HR,PR,BP) two times, first time before listening to Quran and second time 2 minutes after listening to Quran(intervention)
Category
Other

2

Description
Control group: we do not do intervenetion and we do not use placebo and we do just routine care before surgery(without any intervention) and we record hemodynamic changes of patients. we do routine nursing care before surgery for both groups like pulse oximetery,monitoring with ECG and sufficient IV (500ml crystalloid serum 30 min before surgery.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madani hospital in Karaj
Full name of responsible person
Mohammad Khorasani
Street address
Mahan blvd., Jahan shahr city
City
Karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Assistant of Alborz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Javad GHorori
Street address
Research assistant, Ninth floor, Dara building, North Yasaman, Poneh sharghi st, 45 metri Golshahr, Karaj
City
Karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistant of Alborz 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
Alborz University of Medical Sciences
Full name of responsible person
Mohammad Khorasani
Position
B.Sc. Anesthesia
Other areas of specialty/work
Street address
No3, Afshar deadend, Dashtabadi st, Farhadi kia st, Rajayee st, Naziabad
City
Tehran
Postal code
Phone
+98 21 5505 5619
Fax
Email
m_khorasani21@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Zohreh Mahmoodi
Position
PhD of Social Determinants of Health
Other areas of specialty/work
Street address
Mahan blvd., Jahanshah city
City
Baghestan, Karaj
Postal code
Phone
+98 26 3442 7001
Fax
Email
zohrehmahmoodi2011@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Mohammad Khorasani
Position
Bhs Anesthesia
Other areas of specialty/work
Street address
Floor 4, No.3, Afshar Deadend, Dashtabadi st, Rajayee st, Behesht Sq, Nazi Abad, Zone 16, Tehran
City
Tehran
Postal code
1831953571
Phone
+98 21 5505 5619
Fax
Email
m_khorasani21@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...