Protocol summary
-
Study aim
-
Investigating the possible effect of the sound of the Quran on the anxiety of patients admitted to the CCU.
-
Design
-
Clinical trial with parallel group on 68 patients hospitalized in CCU
-
Settings and conduct
-
In this study, which is a clinical trial type; 68 patients admitted to the CCU department of Hazrat Zahra Hospital in Khomein city who meet the criteria for entering the study; They are selected by available (easy) sampling method.
The data collection tool is a two-part questionnaire, the first part of which is related to demographic information and the second part is related to Spielberger's anxiety questionnaire. Patients complete this questionnaire before the intervention. Then, for 15 minutes, they listen to Surah Hamad and verses 1 to 20 of Surah Yusuf in the voice of Professor Abdul Basit. The selection of this surah is based on the previous studies conducted in the country. Auxiliary playback devices in this research will be headphones and mp3 player. Then, after the intervention, the patients complete the Spielberger questionnaire again.
And finally, the results of the Spielberger test before and after the intervention will be compared and the final conclusion will be made.
-
Participants/Inclusion and exclusion criteria
-
Age above 18 years
Being aware of time, place and people
Having a healthy sense of hearing
No history of drug and alcohol addiction
No history of mental illness
History of new crisis such as death of first degree relatives, divorce of self or parents in the last 6 months
The patient's refusal to continue participating in the study
Critical condition of the patient
-
Intervention groups
-
Quran intervention group
-
Main outcome variables
-
Anxiety
General information
-
Reason for update
-
update study protocol
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20240609062052N2
Registration date:
2024-06-27, 1403/04/07
Registration timing:
registered_while_recruiting
Last update:
2024-10-10, 1403/07/19
Update count:
1
-
Registration date
-
2024-06-27, 1403/04/07
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2024-06-26, 1403/04/06
-
Expected recruitment end date
-
2024-07-27, 1403/05/06
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Investigation the therapeutic effect of Holy Quran voices on anxiety in cardiac care unit patients in Hazrat Zahra hospital at Khomein city.
-
Public title
-
Investigation the therapeutic effect of Holy Quran voices on anxiety in cardiac care unit patients
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Having informed consent
Being aware of time, place and people
Having a healthy sense of hearing
Exclusion criteria:
History of drug and alcohol addiction
History of mental illnesses
History of new crisis such as death of first degree relatives, divorce of self or parents in the last 6 months
The patient's refusal to continue participating in the study
Critical condition of the patient
-
Age
-
From 18 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
68
-
Randomization (investigator's opinion)
-
N/A
-
Randomization description
-
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Single
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2024-05-28, 1403/03/08
-
Ethics committee reference number
-
IR.KHOMEIN.REC.1403.009
Health conditions studied
1
-
Description of health condition studied
-
Angina pectoris
-
ICD-10 code
-
I20
-
ICD-10 code description
-
Angina pectoris
2
-
Description of health condition studied
-
Essential (primary) hypertension
-
ICD-10 code
-
I10
-
ICD-10 code description
-
Essential (primary) hypertension
3
-
Description of health condition studied
-
Atherosclerosis
-
ICD-10 code
-
I70
-
ICD-10 code description
-
Atherosclerosis
4
-
Description of health condition studied
-
myocardial infarction
-
ICD-10 code
-
I21
-
ICD-10 code description
-
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
5
-
Description of health condition studied
-
Aortic aneurysm and dissection
-
ICD-10 code
-
I71
-
ICD-10 code description
-
Aortic aneurysm and dissection
Primary outcomes
1
-
Description
-
Anxiety score in Spielberger questionnaire
-
Timepoint
-
Before and after the intervention
-
Method of measurement
-
Anxiety:Spielberger questionnaire
Intervention groups
1
-
Description
-
Intervention group: the sound of the Quran in this study, which is a clinical trial type; 68 patients admitted to the CCU department of Imam Khomeini Hospital (RA) in Khomein city who meet the inclusion criteria; 34 people are randomly assigned to the Qur'an group. The data collection tool is a two-part questionnaire, the first part of which is related to demographic information and the second part is related to the questionnaire. Spielberger's anxiety.Patients complete this questionnaire before the intervention; Then, for 15 minutes, they listen to Surah Hamad and verses 1 to 20 of Surah Yusuf in the voice of Professor Abdul Basit. The selection of this surah is based on the previous studies conducted in the country. Auxiliary playback devices in this research will be headphones and mp3 player. Then, after the intervention, the patients complete the Spielberger questionnaire again. Finally, the results of the Spielberger test before and after the intervention will be compared and the final conclusion will be made.
-
Category
-
Other
2
-
Description
-
Control group: Control group: The control group in this study, which is a clinical trial; 68 patients admitted to the CCU department of Imam Khomeini Hospital (RA) in Khomein city, who meet the criteria for entering the study; 34 people are randomly assigned to the control group. The data collection tool is a two-part questionnaire, the first part of which is related to demographic information and the second part is related to the questionnaire. Spielberger's anxiety. Patients complete this questionnaire before the intervention; Then no intervention is done for the control group and they complete the Spielberger test again like the intervention group. Then the results of control and intervention groups will be compared with each other
-
Category
-
Other
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Khomein Faculty 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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
Yes - There is a plan to make this available
-
Informed Consent Form
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
Yes - There is a plan to make this available
-
Data Dictionary
-
Yes - There is a plan to make this available
-
Title and more details about the data/document
-
All information and data will be shared after de-identifying people.
-
When the data will become available and for how long
-
Access will start 1 month after the results are published.
-
To whom data/document is available
-
All people related to medical and health matters
-
Under which criteria data/document could be used
-
The use of data will only be subject to mention of the source of the study and the authors. It is definitely necessary to obtain permission from the authors and researchers of the study.
-
From where data/document is obtainable
-
with this email: zeidypouya@gmail.com
-
What processes are involved for a request to access data/document
-
After submitting the request and explaining the reason for the request, Dr. Safarabadi, the scientific accountability officer, will review the request and finally, within 72 hours after the request, the result will be informed to the requester.
-
Comments
-