Protocol summary

Study aim
Determining the Effect of Holy Quran Listening on the Anxiety Status Originated from OSC examination among Medical Sciences Students Compared to Control Group
Design
This clinical trial has a community-based and pragmatic design with parallel and simple randomized groups.
Settings and conduct
This research will be carried out at the Khomein Medical School. Students whom registered in September semester of 2016 will be examined for the final practical examinations of principles and care course. Individuals will be assigned into two groups of intervention and control; participants will be unaware about the group they are allocated and the outcome assessors also will be unaware about the group of participants. For intervention group, Qur'an's voice will be played-back for 30 minutes using an specified MP3 player in a singular way and before starting the OSCE. Control category will not hear anything before starting the OSCE.
Participants/Inclusion and exclusion criteria
Participants: Medical Sciences Students Inclusion criteria: no experience of relaxation courses such as yoga and so forth; lack of mental illness and no drug use exclusion criteria: having history of hearing Holy-Quran before final exams;
Intervention groups
30 minute before OSC examination, Holy-Qur'an's playback will be loaded using a MP3 player and in a singular manner. No any intervention will be done for control category.
Main outcome variables
The anxiety status

General information

Reason for update
Acronym
OSCE
IRCT registration information
IRCT registration number: IRCT20100130003227N12
Registration date: 2018-09-28, 1397/07/06
Registration timing: retrospective

Last update: 2018-09-28, 1397/07/06
Update count: 0
Registration date
2018-09-28, 1397/07/06
Registrant information
Name
Ashraf Salehi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 5222 7550
Email address
salehi.a@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-25, 1397/11/05
Expected recruitment end date
2019-01-26, 1397/11/06
Actual recruitment start date
2017-01-24, 1395/11/05
Actual recruitment end date
2017-01-25, 1395/11/06
Trial completion date
2017-01-25, 1395/11/06
Scientific title
Investigating the Effect of Holy Quran Listening on the Anxiety Originated from Objective Structured Clinical Examinationin (OSCE) of Medical Sciences Students Compared to Control Category
Public title
The Effect of Holy Quran Listening on the Anxiety of OSC Examinationin of Medical Sciences students
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Not having a history of attending relaxation classes like yoga and relaxation Lack of mental illness No drug intake
Exclusion criteria:
have history of hearing the Qur'an before all exams
Age
From 17 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 70
Actual sample size reached: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will be assigned into the intervention or control groups using a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be blinded for allocation into intervention or control groups due to randomization and will not be informed about the intervention type (listening to Holy-Qur'an's playback) before study initiation. Outcome assessors (OSCE appliers) will not be informed about the students categorization.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Regional Committee on Ethics in Medical Sciences Research
Street address
Alam al-Hoda St., Shahid Shiroodi Street
City
Arak
Province
Markazi
Postal code
info@arakmu.ac.ir
Approval date
2017-01-26, 1395/11/07
Ethics committee reference number
IR.ARAKMU.REC1395.117

Health conditions studied

1

Description of health condition studied
anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

Primary outcomes

1

Description
Anxiety Scale in the Spielberger Questionnaire
Timepoint
Before the intervention and 30 minutes after the intervention
Method of measurement
Spielberger Standard Anxiety Inventory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 30 minutes before the OSCE exam, a pleasant sound of the Qur'an, will be heard by participant, using a single-player MP3 PLAYER.
Category
Other

2

Description
Control group: There was no intervention in the control group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Khomein Medical School
Full name of responsible person
Hamid Momeni
Street address
Blvd. Ghods - Educational Complex of Zainab
City
Khomein
Province
Markazi
Postal code
3881858573
Phone
+98 86 4622 1533
Fax
+98 86 4622 6007
Email
najm54@yahoo.com
Web page address
http://khomeinums.ac.ir/%D8%A7%D8%B1%D8%AA%D8%A8%D8%A7%D8%B7-%D8%A8%D8%A7-%D9%85%D8%A7

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Alam al-Hoda St., Shahid Shiroodi Street
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3645
Fax
+98 86 3133 6853
Email
Arjomandzadegan.M@arakmu.ac.ir
Web page address
https://vcr.arakmu.ac.ir/Portal/home/?156052/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hamid Momeni
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Zainab Educational Complex- Blvd. Ghods
City
Khomein
Province
Markazi
Postal code
3881858573
Phone
00898646221533
Email
hamid52us@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamid Momeni
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Zainab Educational Complex- Blvd. Ghods
City
Khomein
Province
Markazi
Postal code
3881858573
Phone
+98 86 4622 1533
Email
hamid52us@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ashraf Salehi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Zainab Educational Complex- Blvd. Ghods
City
خمین
Province
Markazi
Postal code
3881858573
Phone
+98 86 4622 1533
Email
najm54@yahoo.com

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
Not applicable
Title and more details about the data/document
A large amount of data, such as information on the main outcome, how to do it, and ... can be shared.
When the data will become available and for how long
Accessible 6 months after printing the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
By observing ethics in research
From where data/document is obtainable
Hamid Momeni hamid52us@yahoo.com
What processes are involved for a request to access data/document
Request to provide data via email.
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