Determining the Impact of Compliance Sustainability Care Model on Sleep Quality in Hemodialysis Patients
Design
The present study is a controlled clinical trial with 40 patients undergoing hemodialysis. After sampling in the available method, they are divided into two groups of intervention and control by random allocation method.
Settings and conduct
Participants in two groups of 20 people in each group will receive counseling and training based on a sustainability model during their 8 45-minute sessions. The training environment is located at the Imam Khomeini Hospital in Sonqor. The sessions are organized on a regular basis twice a week, with prior notice to the patients.
Participants/Inclusion and exclusion criteria
Participants include the family of hemodialysis patients. Inclusion criteria for this study:1- Willingness to cooperate. 2- A history of 6 months of renal disease.
Exclusion criteria:
1- Mental illness
2- Drug Addiction
Intervention groups
The type of intervention is in fact counseling and education. In the intervention group, the adaptive sustainability model helps helping the family of hemodialysis patients to cope with their patient's problem and their attitude towards the rationalization of the disease and vaginal pain is somewhat different. It is subsequently assumed that this adaptation leads to an increase in the quality of sleep in hemodialysis patients. In the control group, only routine training is given
Main outcome variables
Sleep quality of hemodialysis patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170606034353N2
Registration date:2019-05-19, 1398/02/29
Registration timing:retrospective
Last update:2019-05-19, 1398/02/29
Update count:0
Registration date
2019-05-19, 1398/02/29
Registrant information
Name
Soroush Maazinezhad
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 4612 6767
Email address
soroush.maazi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-10, 1397/10/20
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adaptive sustainability care model on sleep quality in hemodialysis patients
Public title
The effect of adaptive sustainability care model on sleep quality
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study
No drug addiction and psychotropic substance
History of at least 6 months of kidney disease
Exclusion criteria:
Having mental illness
Drug addiction
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
After completion of the sampling, 40 sealed envelopes containing the codes 1 (intervention group) and 2
(Control group) control is available to all patients and each person is placed in the selected group according to the selected code.
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 Kermanshah University of Medical Sciences
Street address
Building No. 1, Kermanshah University of Medical Sciences(KUMS), Shahid Beheshti Boulevard, Kermanshah,Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Approval date
2018-12-05, 1397/09/14
Ethics committee reference number
ir.kums.rec.1397.665
Health conditions studied
1
Description of health condition studied
sleep quality
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sleep quality of hemodailysis patient
Timepoint
1 - Before the intervention 2 - Immediately after the end of the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Implementation of Compliance Compliance Model Before the intervention, the quality of sleep in hemodialysis diaphragm is recorded with Pittsburgh sleep quality questionnaire. After completing the intervention, patients' sleep quality is recorded again. Intervention in dialysis treatment center classes is held. The purpose of this intervention is to change the attitude of patients towards the concept of renal disease, hemodialysis, pain and sleep hygiene.
Category
Lifestyle
2
Description
Control group: simple and routine training is done in the field of hygiene
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital in Kermanshah
Full name of responsible person
Hiva Mohammadi
Street address
Building No.Imam Reza Hospital , Parastar Boulevard, Kermanshah,Iran
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3826 5255
Email
Soroush.Maazi@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farid Najafi
Street address
Shahid Beheshti Blv
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3826 5255
Email
Soroush.maazi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Soroush Maazinezhad
Position
Academic Staff
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Farhikhtegan Blv
City
Kermanshah
Province
Kermanshah
Postal code
6718997799
Phone
+98 83 3720 4071
Email
smedical90@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Soroush Maazinezhad
Position
Academic Staff
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Farhikhtegan Blv
City
Kermanshah
Province
Kermanshah
Postal code
6718997799
Phone
+98 83 3720 4071
Email
smedical90@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Soroush Maazinezhad
Position
Academic Staff
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Farhikhtegan Blv
City
Kermanshah
Province
Kermanshah
Postal code
6718997799
Phone
+98 83 4720 4071
Email
smedical90@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