Protocol summary

Study aim
Determining the effect of spiritual intelligence training on hope and psychological well-being of patients with chronic renal failure under hemodialysis
Design
An interventional study is a clinical trial that will be carried out on 68 patients with chronic renal failure under hemodialysis at the entrance to the study , referring to shahidbeheshte Hospital Participants will be assigned into two groups using block randomization .
Settings and conduct
During the eight sessions , the researcher will intervene .
Participants/Inclusion and exclusion criteria
Written consent for participation in research;Patients who have been on for three months since the start of hemodialysis;Not being diagnosed with mental illness;Not being diagnosed with other chronic diseases;Having aged over fifteen years;The simultaneous acquisition of a score of 48 and lower on King's Spiritual Intelligence Score, a score of 365 and a lower on Reef psychological well-being scale and a score of 22 and lower in Schneider's Hope Questionnaire;
Intervention groups
There will be no intervention in the control group . The researcher will present the executive and content schedules contained in the protocol in eight sessions of the one-hour for the subject group . They will all be intercepted by a single person ; with the same content and methodology .
Main outcome variables
hope ; psychological well-being

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180522039783N1
Registration date: 2018-10-20, 1397/07/28
Registration timing: prospective

Last update: 2018-10-20, 1397/07/28
Update count: 0
Registration date
2018-10-20, 1397/07/28
Registrant information
Name
Nastaran Hosseinpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 5144
Email address
hosseinpour.nastaran@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-01-05, 1397/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spiritual intelligence training on hope and psychological well-being of patients with chronic renal failure under hemodialysis
Public title
The effect of spiritual intelligence training on hope and psychological well-being of patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Written consent for participation in research Patients who have been on for three months since the start of hemodialysis Not being diagnosed with mental illness Not being diagnosed with other chronic diseases Having aged over fifteen years The simultaneous acquisition of a score of 48 and lower on King's Spiritual Intelligence Score, a score of 365 and a lower on Reef psychological well-being scale and a score of 22 and lower in Schneider's Hope Questionnaire
Exclusion criteria:
Un willingness to continue participating in the study Performing a kidney transplant during the study Immigration Death
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned into one of two groups using block randomization
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 Yasuj University of Medical Sciences
Street address
No.20 , Iman Ave
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591773739
Approval date
2018-08-04, 1397/05/13
Ethics committee reference number
IR.YUMS.REC.1397.046

Health conditions studied

1

Description of health condition studied
Hope
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Psychological Well-being
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Hope
Timepoint
Before and after the beginning of the intervention
Method of measurement
Schneider Hope Scale

2

Description
Psychological Well-being
Timepoint
Before and after the beginning of the intervention
Method of measurement
Ryff Psychological Well-being Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After performing a pretest on the subjects and control groups,test group will be affected by the researcher According to the protocol (teaching components of spiritual intelligence includes practical exercises) in the course of eight 60-minute sessions . And immediately after the end of the intervention , we will be done for both the control group and the testable . The program is based on the teaching of four components of spiritual intelligence that includes Existential Critical Thinking , the production of personal meaning, the expansion of state of consciousness , and transcendental consciousness. Eight training this program . In these sessions, the following content is maily taught with speake methods to hemodialysis patients . First meeting : Introducing the apps and expectations and regulations Second session :Introduction of spiritual intelligence 1 and practice in this field . Third session : Introduction of spiritual intelligence 2 and practice in this field . Four session : Teaching Humor and practices in this field . Five session : Meditation training and practices in this field . Session Six : Teaching Self-Awareness 1 and practice in this field . seventh session : Teaching Self-Awareness 2 and practice in this field . Eight Session : Critical Thinking teach and practice in this field .
Category
Prevention

2

Description
Control group: there will be no intervention in the control group
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshte Hospital
Full name of responsible person
Seyede Nastaran Hosseinpour
Street address
No.20,Iman Ave
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591773739
Phone
+98 74 3322 3910
Email
hosseinpour.nastaran@yums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr Zoladl Mohammad
Street address
Motahari Blvd, University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3333 7230
Email
zoladl@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Syede Nastaran Hosseinpour
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Family Health
Street address
No.20,Iman Ave
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591773739
Phone
+98 74 3322 3910
Email
hosseinpour.nastaran@yums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Syede Nastaran Hosseinpour
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Family Health
Street address
No.20,Iman Ave
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591773739
Phone
+98 987433223910
Email
hosseinpour.nastaran@yums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Syede Nastaran Hosseinpour
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Family Health
Street address
No.20,Iman Ave
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591773739
Phone
+98 74 3322 3910
Email
hosseinpour.nastaran@yums.ac.ir

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
There is a possibility to share some of the data , such as information about the message.
When the data will become available and for how long
Available 6 month after the results are printed .
To whom data/document is available
The research data will be available to researchers working in academic and academic institutions .
Under which criteria data/document could be used
Use of data and documentation to conduct more research and access to more complete results .
From where data/document is obtainable
You can use e-mail to receive data from the Homestay.
What processes are involved for a request to access data/document
Requests for data and documentation are sent by email . As soon as possible , access to the requested files is available .
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