Effect of the Holy Qur’an Recitation on the inflammatory factors in hemodialysis patients
Design
Controlled randomized clinical trial, with parallel groups, without blindness.
Settings and conduct
This is a randomized controlled clinical trial study in which two groups of intervention (receiving holy qur'an recitation) and control (silent mode) will be done on 50 hemodialysis patients referring to Kowsar hospital affiliated to Semnan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to listen to the Holly Quran; at least six months of treatment with hemodialysis; having hemodynamic stability; no history of recent infection (recent 3 months); obtain Score 10 for the anxiety and 7 for the depression items of the Hospital Anxiety and Depression Scale. Exclusion criteria: Hearing impairment; left handed; reciter of quran; Arabic speaking patients
Intervention groups
Intervention group: Patients who receive the Quran voice (Yasin Surah) for a month, three times per week for 20 minutes (immediately after connecting the patient to the dialysis machine and hemodynamic stability) via headphones.
Control group: Patients who receive only headphones in silent mode (immediately after connecting the patient to the dialysis machine and hemodynamic stability) for one month, three times a week for 20 minutes.
Main outcome variables
Inflammatory factors (IL6, ESR, CRP)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120109008665N9
Registration date:2019-11-04, 1398/08/13
Registration timing:prospective
Last update:2019-11-04, 1398/08/13
Update count:0
Registration date
2019-11-04, 1398/08/13
Registrant information
Name
Hassan Babamohamadi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
babamohamadi@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Holy Qur’an Recitation on the inflammatory factors in Hemodialysis Patients
Public title
The Effect of Holy Qur’an Recitation on the inflammatory factors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to listen to the Holly Quran
Consent to participate in the study
Age range 20 to 65 years
At least six months of treatment with hemodialysis
Consciousness
having hemodynamic stability
No history of recent infection (recent 3 months)
The lack of serious psychiatric problems
Obtain Score 10 for the anxiety and 7 for the depression items of the Hospital Anxiety and Depression Scale (HADS)
No history of long-term use of corticosteroids and immunosuppressive drugs
Exclusion criteria:
left handed
Hearing impairment
Reciter of Quran
Arabic speaking patients
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of samples to two groups (intervention or control) will be done randomly using random blocks method. 25 blocks with 2 cases in each are
created and every time randomly a block will be selected. In this method, A: represent intervention group; B: control.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences (SEMUMS), Vice Chancellor of Research and Technology , Bassij Blvd., Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2019-09-17, 1398/06/26
Ethics committee reference number
IR.SEMUMS.REC.1398.154
Health conditions studied
1
Description of health condition studied
Chronic Kidney Disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Level of the inflammatory factor (IL6)
Timepoint
Before intervention and one month later
Method of measurement
Using an ELISA kit for measuring human IL-6, product of Diaclone France
2
Description
Level of the inflammatory factor (Erythrocyte Sedimentation Rate)
Timepoint
Before intervention and one month later
Method of measurement
ESR measurement using ESR tube containing sodium citrate solution, Product of Teb Shahr Company
3
Description
Level of the inflammatory factor (C Reactive Protein)
Timepoint
Before intervention and one month later
Method of measurement
CRP measurement, using ELISA, Using the XL Selectra device, a product from the Netherlands
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Music therapy intervention on the experimental group are done according to the prepared protocol based on similar studies. The aim of music therapy in this study is application of relaxing and mystical of Holy Quran, Yasin Surah with voice of Shateri Professor (Tartil), that is selected by consulting by a clergyman. This surah is playback 3 times in week, and 20 minutes every session (immediately after connecting the patient to the dialysis machine and hemodynamic stability) through mp3 player and a headphone within a month.
Category
Treatment - Other
2
Description
Control group: for control group, no specific intervention will be applied and they receive only routine cares along with the headphone in silent mode.This procedure is performed 3 times in week, and 20 minutes every session (immediately after connecting the patient to the dialysis machine and hemodynamic stability) through mp3 player and a headphone within a month.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar hospital affiliated to Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Street address
Kowsar Hospital; Amin Blv; Golestan town; Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3104 3209
Fax
+98 23 3343 7837
Email
kowsarhospital@semums.ac.ir
Web page address
http://kosarhos.semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Vice Chancellor of Research and Technology, Basidj Blv, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
rds@semums.ac.ir
Web page address
http://rtvc.semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4192
Fax
+98 23 3365 4209
Email
babamohammady2007@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4192
Fax
+98 23 3365 4209
Email
babamohammady2007@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4192
Fax
+98 23 3365 4209
Email
babamohammady2007@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available