Protocol summary

Summary
Objective: To determine the effect of Quran on the severity of anxiety and depression in patients undergoing hemodialysis. Inclusion criteria: Willingness to listen to the Holly Quran; Consent to participate in the study; Age range 45 to 65 years; At least six months of treatment with hemodialysis; no use of anti anxiety and anti depression drugs; The lack of serious psychiatric problems. Exclusion criteria: Any mental disability; Hearing Impaired; Having a bad experience in the past six months; History of mental illness or psychiatric hospitalization; Changes in physical condition (severe problem) during the study; Cancel or unwillingness to participate in the study. The study population consisted of 60 hemodialysis patients that put into test and control groups randomly. Quran Surah Yasin mystical relaxing music and voice teacher Shateri (Trtyl way) 3 times a week, each session lasting 20 minutes (immediately after connecting the patient to the dialysis machine and vascular stability) through the system with mp3 player headphones play within a month for the test group. but for control group, no specific intervention will be apply. Two questionnaires (Spielberger and Beck) will be completed: 1 - Before starting dialysis in the first session as a baseline, 2 - after a month (after the intervention) to assess the severity of anxiety and depression for all patients in two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201312108665N2
Registration date: 2014-02-06, 1392/11/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-02-06, 1392/11/17
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
Semnan University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Recitation Effect of Holy Quran on Intensity of Anxiety and Depression in Patients Undergoing Hemodialysis.
Public title
Recitation Effect of Holy Quran on Intensity of Anxiety and Depression in Patients Undergoing Hemodialysis.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to listen to the Holly Quran; Consent to participate in the study; Age range 45 to 65 years; At least six months of treatment with hemodialysis; Consciousness; having hemodynamic stability; no use of anti anxiety and anti depression drugs; The lack of serious psychiatric problems. Exclusion criteria: Any mental disability; Hearing Impaired; Having a bad experience in the past six months; History of mental illness or psychiatric hospitalization; Changes in physical condition (severe problem) during the study; Cancel or unwillingness to participate in the study; left handed; clergyman; Reciter of Quran; being Arab language.
Age
From 45 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Semnan University of Medical Sciences
Street address
Basidj Blv, Central staff of Semnan University of Medical Sciences
City
Semnan
Postal code
Approval date
2014-01-07, 1392/10/17
Ethics committee reference number
92/388666

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
Anxiety
Timepoint
Before intervention and after 1 Month
Method of measurement
Spielberger Questionnare

2

Description
Depression
Timepoint
Before intervention and after 1 month
Method of measurement
Beck Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Music therapy intervention on the experimental group are done according to the prepared protocol based on similar studies. scope of music therapy in this study is application of relaxing and mystical of Holy Quran, Yasin Sura with voice of Shateri Professor (Tartil), that is selected by consulting by a clergyman. This sura is playback 3 times in week, and 20 minutes every session (immediately after connecting the patient to the dialysis machine and vascular stability) through mp3 player and a headphone within a month.
Category
Treatment - Other

2

Description
for control group, no specific intervention will be apply and they receive routine cares.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Mahallati Martyr Hospital
Full name of responsible person
Dr Hassan Babamohamadi
Street address
Semnan
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Raheb Ghorbani
Street address
Semnan
City
Semnan
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Hassan Babamohamadi
Position
Assistant Professor, educational deputy
Other areas of specialty/work
Street address
Semnan
City
Semnan
Postal code
3513138111
Phone
+98 23 1335 4192
Fax
+98 23 1335 4177
Email
babamohamadi@sem-ums.ac.irbabamohammady2007@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Hassan Babamohamadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Semnan
City
Semnan
Postal code
3513138111
Phone
+98 23 1335 4192
Fax
+98 23 1335 4177
Email
babamohamadi@sem-ums.ac.irbabamohammady2007@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Hassan Babamohamadi
Position
Assistant Professor, Educational Deputy
Other areas of specialty/work
Street address
Semnan
City
Semnan
Postal code
3513138111
Phone
+98 23 1335 4192
Fax
+98 23 1335 4177
Email
babamohamadi@sem-ums.ac.irbabamohammady2007@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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