A Comparative Study on the Effect of Azan Voice and Water Voice on Depth of Anesthesia and Hemodynamic and Plasma and Blood Glucose Cortisol Levels in Patients Submitted to Laparoscopic Cholecystectomy
Comparison of the Effect of Azan Voice and Water Flow on the Depth of Anesthesia and Hemodynamics of Patients and the Level of Cortisol and Plasma Glucose in Patients During Laparoscopic Cholecystectomy
Design
Randomized double blind clinical trial with control group
Settings and conduct
In this study, 120 samples of patients operating general room of Kashani Hospital in Shahrekord who were candidates for cholecystectomy were selected by simple sampling.They were randomly divided into four groups and matched and operated by a same surgeon.Before induction of anesthesia, all patients are assigned a Bispectral index(BIS) kit and their number and blood pressure and heart rate and the baseline plasma cortisol and blood glucose levels are recorded.For all patients with headphones, the first group of Azan sound, the second group of sound water and the third group no sound, and in the control group, headphones are not installed.After induction of anesthesia, in 5 to 35 minutes, the variables are checked in all groups.After completing surgery in recovery, in addition to hemodynamics, pain and anxiety score and cortisol and blood glucose levels are measured.Patient information is recorded separately in the checklist and analyzed.
Participants/Inclusion and exclusion criteria
All individuals aged 20 to 60 years without disease candidate for laparoscopic cholecystectomy
Intervention groups
The patients were divided into 4 groups: the first group was the Azan sound, the second group was waterless and the fourth group was without sound.
A Comparative Study on the Effect of Azan Voice and Water Voice on Depth of Anesthesia and Hemodynamic and Plasma and Blood Glucose Cortisol Levels in Patients Submitted to Laparoscopic Cholecystectomy
Public title
A Comparative Study of Voices on Patients under Surgery
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 20-60 years undergoing laparoscopic cholecystectomy No history of restrictive disease Lack of uncontrolled blood pressure and diabetes and glucose intolerance Don’t use opioid or hypnotic drugs Lack of hearing loss Lack of a history of a disease or use of a medication that disturbs the level of normal cortisol levels of plasma and blood glucose BMI<30 Asa class 1,2 Patient satisfaction from participating in the plan
Exclusion criteria:
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using the Random Allocation Software , and in that third party, categorize the groups into A = Azan, B = Water, C = No-Audio Headphones and D = Controller and At the top of the questionnaire, the group is identified with the letter and after entering the patient opens the questionnaire and prepares the patient with the same intervention And the researcher does not know until the completion of sampling what kind of letter is defined by each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients were not aware of which group they were and the researcher did not know which group was in each case and the questionnaire was completed by a third person.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Shahrekord, Kashani Blvd., Headquarters of the University
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2016-08-28, 1395/06/07
Ethics committee reference number
IR.SKUMS.REC.1395.137
Health conditions studied
1
Description of health condition studied
Patients undergoing laparoscopic cholecystectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Depth of Anesthesia
Timepoint
Before induction of anesthesia and immediately after and 5 to 35 minutes after induction and immediately after surgery in recovery and one hour after surgery in recovery
Method of measurement
BIS KIT
2
Description
Blood pressure
Timepoint
Before induction of anesthesia and immediately after and 5 to 35 minutes after induction and immediately after surgery in recovery and one hour after surgery in recovery
Method of measurement
Mercury barometric device
3
Description
Heart rate
Timepoint
Before induction of anesthesia and immediately after and 5 to 35 minutes after induction and immediately after surgery in recovery and one hour after surgery in recovery
Method of measurement
Pulse oximetry
4
Description
Plasma cortisol
Timepoint
Before induction of anesthesia and an hour after surgery in recovery
Method of measurement
Serum test
5
Description
Blood sugar
Timepoint
Before induction of anesthesia and an hour after surgery in recovery
Method of measurement
Serum test
6
Description
Pain score
Timepoint
Immediately after surgery and an hour later in recovery
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group:
Category
Treatment - Surgery
2
Description
Intervention group:
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
kashani hospital
Full name of responsible person
Dr Saeed Aali
Street address
parastar street,kashani hospital
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۸۹۱۵
Phone
+98 38 3226 4825
Fax
+98 38 3222 8600
Email
Kashani@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Seyed Mohammad Omrani
Street address
Shahrekord, Rahmatieh, Educational Complex of Shahrekord University of Medical Sciences
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۵۷۱-۸۸۱۵۵
Phone
+98 38 3333 9940
Email
res.med@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Hossein Madineh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
parastar street,kashani hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۸۹۱۵
Phone
+98 38 3226 4825
Email
madineh@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Hossein Madineh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
parastar street,kashani hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۸۹۱۵
Phone
+98 38 3226 4825
Email
madineh@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ebrahim Tavafzade
Position
Assistant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Parastar st.kashani hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8178637173
Phone
+98 31 3788 9094
Fax
Email
Ebrahimtavaf1561@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available