Determining the effectiveness of spiritual intervention program on hemodialysis patients' sleep quality
Design
The current study is a two-group randomized clinical trial that will be conducted with the participation of 100 patients. The research units will be selected by convenience sampling method and will be allocated into control and intervention groups by using randomization of the permutation block method.
Settings and conduct
The present study is a two-group randomized clinical trial that will be conducted with 100 hemodialysis patients in Hamadan. In the intervention group, spiritual intervention sessions will be held during six sessions, two sessions each week for 45 to 60 minutes by the researcher. The topics of the sessions will include the assessment of spiritual hemodialysis patients' needs, religious care, spiritual-supportive care, spiritual care, psychological care, and spiritual care evaluation. After the spiritual intervention, the patients' sleep quality will be evaluated one month and two months after the last care session. The control group will receive only usual medical care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of chronic kidney failure by a doctor, not having mental disorders, and not having vision and hearing diseases. Exclusion criteria: Patient death during the study, absence more than once in meetings, and Unwillingness to continue participating in the study.
Intervention groups
The sessions of spiritual intervention program will be held in six sessions, two sessions per week for 45 to 60 minutes by the researcher for the intervention group. After the spiritual intervention, the patients' sleep quality will be evaluated one month and two months after the last care session. Control group: Patients in the control group will receive only routine care.
Main outcome variables
Patients' sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N41
Registration date:2022-11-11, 1401/08/20
Registration timing:prospective
Last update:2022-11-11, 1401/08/20
Update count:0
Registration date
2022-11-11, 1401/08/20
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of spiritual intervention program on hemodialysis patients' sleep quality
Public title
Effectiveness of spiritual intervention program on sleep quality
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of chronic kidney failure by a doctor
Not having mental disorders
Not having vision and hearing diseases
Exclusion criteria:
Patient death during the study
Absence more than once in meetings
Unwillingness to continue participating in the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method will be done using the permutation block method. In such a way that first, four blocks of ABBA, AABB, and ABAB, BBAA, BAAB, BABA will be produced in a number that covers the study sample and will be placed in envelopes. Then, when the patients enter the study, one of the envelopes will be randomly selected and the first four patients will be assigned to two groups according to the desired block. This process will continue until the total number of samples is completed.
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 Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2022-10-22, 1401/07/30
Ethics committee reference number
IR.UMSHA.REC.1401.626
Health conditions studied
1
Description of health condition studied
Hemodialysis patients
ICD-10 code
Z99.2
ICD-10 code description
Dependence on renal dialysis
Primary outcomes
1
Description
patients' sleep quality
Timepoint
One month and two months after the intervention
Method of measurement
Petersburg sleep quality questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, the spiritual intervention program's sessions will be held in six sessions, two weekly sessions for 45 to 60 minutes. The content of these sessions is based on identifying the spiritual needs of Iranian patients and matching them with international clinical guidelines and related texts. The Spiritual intervention program has been localized by a group of experts in Iran's health system. The sleep quality questionnaire will be completed one month and two months after the last session of spiritual intervention.
Category
N/A
2
Description
Control group: Control group: The control group will receive only routine medical care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Mohammad Torabi
Street address
Hamedan - the beginning of Eram Boulevard - Shahid Beheshti Hospital
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 918 316 0499
Email
mtorabi316@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokouhi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
shokoohi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Torabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
mtorabi316@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Torabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
mtorabi316@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Torabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
mtorabi316@gmail.com
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
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
Undecided - It is not yet known if there will be a plan to make this available