This study has intervention and control groups and is blind on one side. The sample size predicted for this study is 106 people and will be randomized into blocks
Settings and conduct
This study will be carried out at the Golestan Hospital of Ahvaz in the Department of Cardiac Surgery. Blind study will be done using a research fellow. So that the researcher who has the task of evaluating the outcome is not informed about the allocation of patients.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age of 18 to above; having the orientation to time, place, person; Being Muslim; Lack of mental disorders; Speak Farsi
Exclusion criteria: Alcoholism or substance abuse; having a hearing problem; not having the consent to enter the study
Intervention groups
In this study, for the intervention group after extubation, twice a day, each time for 10 minutes, the Quran of Karim with the voice of Abdul Basit Abdul-Samad, which is read in the form of a reciting from the Sura Yusuf, is broadcast using headphones.
Main outcome variables
Delirium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171222037990N1
Registration date:2018-11-27, 1397/09/06
Registration timing:registered_while_recruiting
Last update:2018-11-27, 1397/09/06
Update count:1
Registration date
2018-11-27, 1397/09/06
Registrant information
Name
Farhan Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 2621 6789
Email address
f.mousavi@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-02-04, 1397/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of the voice of Quran on delirium prevention after cardiac surgery
Public title
Effect of Qur'anic Voice on Delirium Prevention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to above
having orientation to time, place, person
Being Muslim
Lack of mental disorders
Speak Farsi
Exclusion criteria:
Alcoholism or substance abuse
Having a hearing problem
Not having the consent to enter the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are allocated to treatment or control groups by block randomization.
To blind the study, another person who is being studied as a research fellow is used. The colleague of the researcher has the task of assigning patients to the intervention and control groups and the researcher will not know how to allocate patients
Blinding (investigator's opinion)
Single blinded
Blinding description
The colleague of the researcher will be responsible for assigning patients to the control and intervention groups, and the researcher who has the task of evaluating the outcome will not know how to allocate patients.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee for Medical Research at Shahed University
Street address
shahed university
City
tehran
Province
Tehran
Postal code
3319118651
Approval date
2018-10-29, 1397/08/07
Ethics committee reference number
IR.SHAHED.REC.1397.056
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
Primary outcomes
1
Description
Delirium is one of the oldest known medical disorders, an acute and transient disorder in brain function that is associated with reduced attention and recognition. Delirium is characterized by acute cognitive impairment, fluctuation in mental state, disordered consciousness, neglect, or unorganized thinking.
Timepoint
In this study, delirium is evaluated twice daily at 10 to 11 and 17 to 18 .
Method of measurement
The Confusion Assessment Method for the ICU (CAM-ICU) The CAM-ICU tool examines the four main characteristics of delirium (acute change or fluctuation of patient mental state, distraction, disturbances of consciousness, and unorganized thinking). Delirium is positive if criterion 1 is followed by criterion 2 and one of criteria 3 or 4. This tool has yes or no response, and it takes 2-5 minutes to complete and can be completed by a doctor or nurse.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, after extubation, twice a day, and each time, for ten minutes, the Quran of the Holy Qur'an is broadcast by headphones with the voice of Master Abdul Baset, which is read in the form of a trilate from the Surah Yusuf.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Seyed Farhan Mousavi
Street address
Golestan Ave
City
Ahwaz
Province
Khouzestan
Postal code
6459119145
Phone
+98 61 3374 3001
Email
farhanmuosavi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Zahra Kia Salari
Street address
Freedom of the Persian Gulf, Shahed University
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
Email
info@shahed.ac.ir
Web page address
http://shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Seyed Farhan Mousavi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No3; Ayatollah Taleghani
City
Shushtar
Province
Khouzestan
Postal code
6459119145
Phone
+98 36 2789
Email
Farhanmuosavi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mohammad reza Heidari
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran, Shahed university
City
tehran
Province
Tehran
Postal code
6459119145
Phone
+98 61212146
Email
mheidari@shahed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Seyed Farhan Mousavi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 3; Street Ayatollah
City
Shushtar
Province
Khouzestan
Postal code
6459119145
Phone
+98 36 16789
Email
farhanmuosavi@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