View older revisions Content changed at 2019-07-09, 1398/04/18

Protocol summary

Study aim
Investigate the effect of Holy Quran voice on prevention of delirium after cardiac surgery.
Design
This study has intervention and control groups and is blind on one side. The sample size predicted for this study is 108 people and will be randomized into blocks
Settings and conduct
TIn this randomized clinical trial, 108 patients with cardiac surgery referred to Golestan Hospital in Ahvaz in 2018 will be selected using the consecutive sampling and randomly assigned into groups of experimental and control. In the intervention group, the voice of Quran plays twice daily for 10 minutes each time. Patients are evaluated twice daily for Delirium. In the control group, routine care will be performed. 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; Talking in Farsi Exclusion criteria: Alcoholism or substance abuse; having a hearing problem; not having the consent to enter the study
Intervention groups
In the intervention group, the voice of the Quran plays twice daily for 10 minutes each time. Patients are evaluated twice daily for Delirium. In the control group, routine care is performed.
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: 2019-07-09, 1398/04/18
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 Holy Quran Voice on delirium prevention after cardiac surgery
Public title
The effect of Holy Quran Voice on Prevention of Delirium
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to above Having orientation to time, place, person Being Muslim Lack of mental disorders Talking in 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: 108
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients will be randomly assigned to the study. By assigning the letter A to the intervention group and the letter B to the control group, the ABBA ،BABA ،ABAB ،BBAA ،AABB ،BAAB are written in separate sheets and inserted into the container. Then, we randomly take one of these sheets out of the container and write the written compound on it and replace that sheet inside the container. Since the sample size in this study is 108 patients, this procedure is repeated twenty-seven times, and each time the composition is written on each sheet in the sequence of the compound written in the previous sheet is noted. Then each of the letters of a number from one to 108 is assigned sequences written in sequence, and each of the letters is placed inside a packet and written on the envelope of that letter. Each time the patient is selected, one of these packets is opened in the order of the number written on the envelope, and it is determined that the patient should be placed in the intervention or control group.
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, Tehran-Qom Express Way, Opposite Imam Khomeini's Shrine, Tehran, Iran.
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
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)

Secondary outcomes

1

Description
Sleep score
Timepoint
The researcher will assess the quality and quantity once a day at 12 noon.
Method of measurement
Richard Campbell questionnaire.

2

Description
Anxiety Score
Timepoint
The level of anxiety will be evaluated on the first day of admission and on the day of discharge.
Method of measurement
Hospital Anxiety and Depression Scale (HADS)

Intervention groups

1

Description
"Intervention group": After the extubation of the patient, the voice of the Quran will be broadcast twice a day by the headphones for ten minutes.
Category
Prevention

2

Description
Control group: routine care is provided in this group.
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. Golestan Hospital
City
Ahwaz
Province
Khouzestan
Postal code
6459119145
Phone
+98 61 3374 3001
Email
golestanhospital@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Zahra Kia Salari
Street address
Shahed University, Tehran-Qom Express Way, Opposite Imam Khomeini's Shrine, Tehran, Iran.
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
No. 3, Ayatollah Taleghani Ave.
City
Shushtar
Province
Khouzestan
Postal code
6459119145
Phone
+98 362789
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
Nursing
Street address
Department of Nursing, Shahed University, Tehran-Qom Express Way, Opposite Imam Khomeini's Shrine, 3319118651, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 51212146
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, Ayatollah Taleghani Ave.
City
Shushtar
Province
Khouzestan
Postal code
6459119145
Phone
+98 3616789
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
Loading...