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The effect of using Orem self-care model on self-efficacy and fatigue severity in patients with renal failure Under hemodialysis treatment

Protocol summary

Study aim
the effect of using Orem's self-care model on self-efficacy and fatigue severity of hemodialysis patients
Design
The clinical trial has a control group and an intervention in a factorial form, which is block randomized, and the randomization table is used, and blinding is not done.
Settings and conduct
the patients who underwent hemodialysis are selected as the study sample by random sampling from the list of patients available on the website. The samples are assigned to two groups using the random block method and the total sample size is 70 people. Data collection will be done in two stages before the intervention, immediately after the selection of samples. In the intervention group, after responding to the research tool in the first stage, the intervention based on the Orem self-care model (universal self-care need, growth and development, and deviation from health) is performed in addition to the usual care in the dialysis department. The self-care training program will be implemented twice a week in 8 sessions in groups of 6-10 people during hemodialysis. The duration of each session will be a maximum of 45 minutes, and the intervention will be carried out for 2-3 weeks in hemodialysis centers, and if necessary, educational aids including educational videos, posters, and pamphlets will be used.
Participants/Inclusion and exclusion criteria
At least 18 years old Dialysis for at least three months Ability to communicate verbally reading and writing
Intervention groups
The OREM model is checked on patients' fatigue and self-efficacy, in this way, training and support sessions are held for the intervention group, and the checklist for training is monitored daily by the researcher, while the control group only completes the pre- and post-test questionnaires.
Main outcome variables
orem self care, self-efficacy, fatigue severity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221015056175N1
Registration date: 2022-12-24, 1401/10/03
Registration timing: retrospective

Last update: 2022-12-24, 1401/10/03
Update count: 0
Registration date
2022-12-24, 1401/10/03
Registrant information
Name
Sedigheh Hooshmandnasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 7230
Email address
s.hooshmandnasab1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-19, 1401/08/28
Expected recruitment end date
2022-12-06, 1401/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using Orem self-care model on self-efficacy and fatigue severity in patients with renal failure Under hemodialysis treatment
Public title
The effect of Orem model on self-efficacy and fatigue severity in patients Under hemodialysis treatment
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hemodialysis patient with a history of at least 3 months of dialysis in at least 2 sessions per week for 2 to 4 hours Sign the written consent Age over 18 years The ability to communicate verbally Understanding the Persian language and reading and writing Cut point of fatigue and self-efficacy score (score 23)
Exclusion criteria:
Having a history of neurological and mental diseases and visual, auditory or speech defects based on the family report The study will be conducted on patients with two systems of partial compensatory nursing and supportive education, and patients with complete compensatory nursing systems will not participate in the intervention
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
They are selected as study samples by random sampling from the list of patients available on the website . The samples are allocated to two groups (35 people in the control group and 35 people in the intervention group) using the random block method and the total sample size is 70 people Randomization through the table available on the website where the pre-test questionnaire is entered into the table as a control or intervention and is randomly selected.
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 Yasouj University of Medical Sciences
Street address
1st floor Motahari Blvd, University of Medical Sciences, Education, Research and Technology Deputy Building
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2022-11-01, 1401/08/10
Ethics committee reference number
IR.YUMS.REC.1401.103

Health conditions studied

1

Description of health condition studied
Hemodialysis patients
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
Self-efficacy
Timepoint
Before the intervention and one month after the intervention
Method of measurement
SUPPH Self-Efficacy Questionnaire and

2

Description
fatigue intensity
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Crop Fatigue Specific Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, after responding to the research tool in the first stage, the intervention based on the Orem self-care model (universal self-care need, growth and development, and deviation from health) is performed in addition to the usual care in the dialysis department. The researcher will design and compile a self-care program according to the needs of self-care based on the Orem model in the form of a supportive educational nursing system. The self-care training program will be implemented twice a week in 8 sessions in groups of 6-10 people during hemodialysis. The duration of each session will be a maximum of 45 minutes, and the intervention will be carried out for 2-3 weeks in hemodialysis centers, and if necessary, educational aids including educational videos, posters, and pamphlets will be used.
Category
Rehabilitation

2

Description
Control group: In the control group, no intervention will be done during the research, only after the end of the work, if the intervention is successful, a training session will be held for the control group in relation to the training given to the intervention group.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
SHahid beheshti hospital
Full name of responsible person
Dr rozina abbasi
Street address
Shahid Mohammad Montazeri St
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
1111111111
Phone
+98 74 3322 4721
Email
s.hooshmandnasab1@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Seyedamin Hosseini Mutlaq
Street address
Vice President of Research and Technology, Headquarters of Yasouj University of Medical Sciences, Shahid Motahari Boulevard
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
1111111111
Phone
+98 74 3334 6078
Email
en@yums.ac.ir
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
صدیقه هوشمندنسب
Position
محقق
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
University of Medical Sciences, Motahari Blvd, Yasouj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
33346070-074
Email
s.hooshmandnasab1@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sedigheh Hooshmandnasab
Position
Master
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
The headquarters of University of Medical Sciences, Motahari Blvd, Yasouj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
1111111111
Phone
+98 74 3333 7230
Fax
Email
s.hooshmandnasab1@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sedigheh Hooshmandnasab
Position
Master
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Central Headquarters of the University of Medical, Motahari Blvd, Yasouj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
1111111111
Phone
+98 74 3333 7230
Fax
Email
s.hooshmandnasab1@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
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