Determining the effect of spiritual care program on sleep quality and treatment adherence of hemodialysis patients referred to Urmia hemodialysis centers in 2024
Design
A clinical trial with a parallel, randomized, and control group will be performed on 80 hemodialysis patients. The sample size will be 40 patients for each group in this study. Participants will be randomly divided into intervention and control groups, and a random number generator software will be used for randomization.
Settings and conduct
The study setting will be the Dialysis department of Imam Khomeini and Taleghani hospitals in Urmia. The study population will be all patients undergoing dialysis, and there will be no blindness in our study.
Participants/Inclusion and exclusion criteria
Diagnosis of chronic kidney failure by a nephrologist; having hemodialysis three times a week for 3 to 4 hours; Age between 32 and 68 years; Willingness to participate in the study; having the ability to listen and speak; having literacy to read and write; being a muslim.
Intervention groups
The control group will receive routine hospital care. The intervention group will receive four one-hour sessions twice a week in addition to routine hospital care.
Main outcome variables
Sleep quality, treatment adherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131112015390N9
Registration date:2024-03-01, 1402/12/11
Registration timing:prospective
Last update:2024-03-01, 1402/12/11
Update count:0
Registration date
2024-03-01, 1402/12/11
Registrant information
Name
Naser Parizad
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1348 7649
Email address
parizad.n@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-05, 1402/12/15
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of spiritual care program on sleep quality and treatment compliance of patients undergoing hemodialysis
Public title
Investigating the effect of spiritual care program on dialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The patient's chronic kidney failure has neen confirmed by the nephrologist.
The patient should be dialyzed three times a week for 3-4 hours.
The patient is aged between 32 and 68 years.
Patients who are willing to participate in the study.
Patients who have no hearing and speech problems.
Patients who can read and write.
Patients who are Muslim
Exclusion criteria:
Patients with heart failure.
Patients who belong to other religions.
Age
From 32 years old to 68 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization was done in two stages. First, Imam Khomeini Hospital (RH) and Shahid Taleghani Hospital were divided into intervention and control groups by throwing a coin. Then, the patients of the hemodialysis department of Imam Hospital (RH) and Taleghani Hospital entered the study using a simple random sampling. Random numbers were created by the random number generator software.
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 Urmia University of Medical Sciences
Street address
Emergency alley, Resalat Boulevard, Urmia University of Medical Sciences, Urmia.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2023-08-30, 1402/06/08
Ethics committee reference number
IR.UMSU.REC.1402.175
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18.9
ICD-10 code description
Chronic kidney disease, unspecified
Primary outcomes
1
Description
The mean sleep quality score using the Pittsburgh Sleep Quality Questionnaire
Timepoint
Measuring sleep quality at the beginning of the study (before the study started) and after the study was completed
Method of measurement
The Pittsburgh Sleep Quality Questionnaire
2
Description
The mean adherence to treatment score using questionnaire of adherence to treatment in patients with chronic kidney failure
Timepoint
Measuring adherence to treatment at the beginning of the study (before the study started) and after the study was completed
Method of measurement
questionnaire of adherence to treatment in patients with chronic kidney failure
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to receiving ward routine care, patients in the intervention group will receive spiritual care individually for four one-hour sessions twice weekly.
Category
Rehabilitation
2
Description
Control group: The control group will only receive routine ward care. This care includes taking care of the dialysis catheter insertion site and educating the patient about proper nutrition, adequate rest, adherence to the medication regimen, and limiting fluid intake.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Teaching Hospital
Full name of responsible person
Maryam Rahimpour
Street address
Ayat Allah Madras Blvd., Ershad Blvd., Imam Khomeini Teaching Hospital, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
81351-57157
Phone
+98 914 176 1926
Email
nursemaryam1370@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr.Saber Gholizadeh
Street address
Headquarters of Urmia University of Medical Sciences, Resalat Blvd., Jahad Ave.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
sabergholizadeh@yahoo.com
Web page address
Grant name
Urmia University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Naser Parizad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery; Nazloo Campus; 11 km of Seru Road; Urmia; West Azarbaijan; Iran.
City
Urmia
Province
West Azarbaijan
Postal code
57561-15335
Phone
+98 44 3275 4961
Email
parizad.n@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Naser Parizad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery; Nazloo Campus; 11 km of Seru Road; Urmia; West Azarbaijan.
City
Urmia
Province
West Azarbaijan
Postal code
57561-15335
Phone
+98 44 3275 4961
Email
parizad.n@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Naser Parizad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery; Nazloo Campus; 11 km of Seru Road; Urmia; West Azarbaijan.
City
Urmia
Province
West Azarbaijan
Postal code
57561-15335
Phone
+98 44 3275 4961
Email
parizad.n@umsu.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available