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Investigating the effect of spiritual care based on Sound-Heart model on Pain, Fatigue and life expectancy of hemodialysis patients

Protocol summary

Study aim
Investigating the effect of spiritual care based on Sound-Heart model on pain, fatigue and life expectancy of hemodialysis patients referred to the hemodialysis center of Ostad Motahari Jahrom Hospital in 2024
Design
A clinical trial with a control group, parallel groups, and randomized block design was conducted on 68 patients. Randomization was carried out using the Random Allocation Software.There is no blindness in this study.
Settings and conduct
This study will be conducted at the Hemodialysis Center of Ostad Motahari Hospital in Jahrom. Each patient will receive six in-person sessions of spiritual care, with two sessions per week.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Having a weekly hemodialysis schedule, having been on hemodialysis for at least one year, no history of previous kidney transplantation, aged between 18 and 80 years, Muslim, full awareness of time, place, and person, not deaf to ensure effective communication, physical and mental readiness to answer questions, and no history of mental illness or use of psychiatric medications. exclusion criteria :occurrence of a crisis event affecting the patient after the start of the research, the patient's unwillingness to continue participating in the study, hospitalization due to disease relapse or transplantation, and death of the patient during the course of the study.
Intervention groups
In the intervention group, spiritual care will be provided based on the Salim Heart Model. Patients will receive spiritual care in addition to their regular care and during dialysis. The spiritual care will be based on religious spirituality and will focus on improving four relationships of human beings: relationship with God, relationship with oneself, relationship with others, and relationship with the environment.Control group: will receive routine care
Main outcome variables
Pain, Fatigue and Life Expectancy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240511061750N1
Registration date: 2024-09-11, 1403/06/21
Registration timing: prospective

Last update: 2024-09-11, 1403/06/21
Update count: 0
Registration date
2024-09-11, 1403/06/21
Registrant information
Name
zahra sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5422 5721
Email address
z.sadeghi@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of spiritual care based on Sound-Heart model on Pain, Fatigue and life expectancy of hemodialysis patients
Public title
Effect of Spiritual care based on Sound-Heart model on pain, fatigue and life expectancy of hemodialysis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a hemodialysis schedule every week At least one year has passed since the patient started hemodialysis Without a previous history of kidney transplant Muslim Full awareness of time, place, and person Not being deaf in order to establish effective communication Physical and Mental Readiness of the Patient for Answering Questions No history of mental illness or use of psychiatric medications Possessing at least basic literacy skills and the ability to speak Persian
Exclusion criteria:
Occurrence of a crisis event affecting the patient after the research has begun The patient's unwillingness to continue participating in the study Hospitalization of the patient due to disease relapse Patient undergoing transplantation or death during the course of the study
Age
From 18 years old to 80 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
Patients undergoing hemodialysis will be included in the study using a convenience sampling method. Once the number of participants is determined, they will be allocated into intervention and control groups using block randomization. Specifically, 17 blocks of 4 will be used for this purpose, with random allocation managed through the Random Allocation Software version 2.
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 Jahrom University of Medical Sciences
Street address
Medical School,Pardis Campus, Motahari Boulevard
City
Jahrom
Province
Fars
Postal code
7414846199
Approval date
2024-07-13, 1403/04/23
Ethics committee reference number
IR.JUMS.REC.1403.013

Health conditions studied

1

Description of health condition studied
Hemodialysis patients
ICD-10 code
Z49
ICD-10 code description
Encounter for care involving renal dialysis

Primary outcomes

1

Description
Fatigue
Timepoint
Before the intervention , immediately after the intervention, and one month after the intervention.
Method of measurement
Multidimensional Fatigue Inventory (Mfi)

2

Description
Pain
Timepoint
Before the intervention , immediately after the intervention, and one month after the intervention
Method of measurement
Numeric Pain Rating Scale (Nprs)

Secondary outcomes

1

Description
Life Expectancy
Timepoint
Before the intervention , immediately after the intervention, and one month after the intervention
Method of measurement
Snyder Life Expectancy Questionnaire

Intervention groups

1

Description
Intervention Group: Spiritual care will be provided based on the Salim Heart Model. In addition to their usual care and during dialysis, patients will receive this spiritual care. The spiritual care will be based on religious spirituality and will focus on improving the four key relationships of the individual: relationship with God, relationship with oneself, relationship with others, and relationship with the environment. Each patient will receive six sessions of spiritual care (totaling 68 sessions), conducted twice a week on hemodialysis days, between 8 AM to 12 PM or 2 PM to 6 PM.
Category
Lifestyle

2

Description
Control group: will receive routine care
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ostad Motahari Hospital Hemodialysis Center, Jahrom
Full name of responsible person
Zahra Sadeghi
Street address
Ostad Motahari Hospital, Ostad Motahari Boulevard
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5432 6085
Email
Sadeghi.zahra.6422@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr. Amir Abdoli
Street address
Jahrom University of Medical Sciences, Motahari Boulevard, Jahrom
City
Jahrom
Province
Fars
Postal code
7414946199
Phone
+98 71 5444 0821
Email
a.abdoli25@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Zohre badiyepeyma jahromy
Position
Asistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Jahrom University of Medical Sciences, At the end of Shahid Motahari St., Jahrom, Fars, Iran.
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0405
Email
z.badiyepeyma@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Zohre Badiyepeyma Jahromy
Position
Asistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Jahrom University of Medical Sciences, At the end of Shahid Motahari St., Jahrom, Fars, Iran.
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0405
Email
z.badiyepeyma@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Zahra Sadeghi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ebrat ُStreet,Jahrom
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5422 5721
Fax
Email
Z.sadeghi@jums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the privacy of the subjects these items are not shared.
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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data that are going to be available will be discussed in chapters four and five of the thesis and finally a brief explanation of them will be given in the article extracted from thesis.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
access for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
To publish articles and scientific references
From where data/document is obtainable
Jahrom University of Medical Sciences, Dr. Zohra Badiyepeyma Jahrom.
What processes are involved for a request to access data/document
In order to obtain the required data, dear researchers can send an email to Dr. Zohra Badiye Peyma at z.badiyepeyma@gmail.com, which will be answered within 14 days.
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