Determination of the effect of spiritual counseling on the fear of death in hemodialysis patients
Design
This study is a randomized, double-blind clinical trial with a control group in which 86 patients undergoing hemodialysis referring to Modarres Hospital in Saveh in 1398 will participate.
Settings and conduct
The present study will be conducted at the Dialysis Center of Modares Hospital in Saveh on hemodialysis patients. The outcome evaluator and the statistical analyzer will not know how to place the samples in the intervention and control groups. Also, spiritual counseling will be done individually twice a week, including 6 sessions in the morning or evening.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients undergoing hemodialysis for at least 3 months
Patients undergoing hemodialysis regularly 3 times a week
Age between 18 to 65 years’ old
The desire to participate in the study
Having the ability to attend meetings
exclusion criteria: the lack of full awareness of time, place, and individuals
Intervention groups
In the intervention group, in addition to the usual treatments, spiritual counseling will be done individually twice a week, including six sessions in the morning or evening shift in the hemodialysis department. Each session lasts between 20 and 45 minutes. Spiritual counseling approach in this research will be based on spiritual interventions and religious beliefs. It also includes Spiritual imagination, Benson's progressive muscle relaxation, hearing music using educational CD, reading the Qur'an, doing forgiveness exercises, and more. The control group will receive only the usual treatment during this period.
Main outcome variables
Fear of Death
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161210031328N10
Registration date:2019-05-09, 1398/02/19
Registration timing:prospective
Last update:2019-05-09, 1398/02/19
Update count:0
Registration date
2019-05-09, 1398/02/19
Registrant information
Name
Mahbobeh Sajadi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3402 0115
Email address
m.sajadi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studt of the effect of spiritual counseling on fear of death in hemodialysis patients
Public title
The effect of spiritual counseling on fear of death in hemodialysis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing hemodialysis for at least 3 months
Patients undergoing hemodialysis regularly 3 times a week
Age between 18 to 65 years old
The desire to participate in the study
Having the ability to attend meetings
Exclusion criteria:
Unwillingness to participate in the study
Lack of full awareness of time, place and individuals
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are divided into intervention and control groups using randomized block allocation method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Individuals with inclusion criteria are divided into intervention and control groups according to the random numbers table. One of the groups is A and the other is called B. Before and after the intervention, the information is collected by the evaluator of the outcome that is unaware of the Classification of the groups. Data analysis is also done by someone who is unaware of the allocation of groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Alam al hoda St, Rail road St
City
Arak
Province
Markazi
Postal code
3814957558
Approval date
2019-01-22, 1397/11/02
Ethics committee reference number
IR.ARAKMU.REC.1397.294
Health conditions studied
1
Description of health condition studied
Dialysis
ICD-10 code
Y84.1
ICD-10 code description
Kidney dialysis
Primary outcomes
1
Description
Fear of death
Timepoint
At the beginning of the study and six weeks later
Method of measurement
The Collett-Lester fear of death scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, in addition to the usual treatments, spiritual counseling will be done individually twice a week, including six sessions in the morning or evening shift in the hemodialysis department. Each session lasts between 20 and 45 minutes. Spiritual counseling approach in this research will be based on spiritual interventions and religious beliefs. It also includes Spiritual imagination, Benson's progressive muscle relaxation, hearing music using educational CD, reading the Qur'an, doing forgiveness exercises, and more.
Category
N/A
2
Description
Control group: The control group will not receive intervention from the research team during this period.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modares Hospital
Full name of responsible person
Mahbobeh Sajadi
Street address
Shahid Modares Hospital, Modares Sq.
City
Saveh
Province
Markazi
Postal code
3915953983
Phone
+98 86 4222 3026
Email
info@savehums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjomandzadegan
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
info@arakmu.ac.ir
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
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
sajadimahbobeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
info@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
sajadimahbobeh@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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data, such as information on the main outcome and the demographic information, can be shared.
When the data will become available and for how long
2 years after publishing of results.
To whom data/document is available
Researchers in academic and scientific institutions.
Under which criteria data/document could be used
In order to utilize scientific purposes and mention the source used
From where data/document is obtainable
Dr. Mahbobeh Sajadi E-mail address: sajadimahbobeh@yahoo.com
What processes are involved for a request to access data/document
After receiving the email, the information will be sent within 4 to 5 working days.