Determining the effect of interdisciplinary training on self-efficacy and life satisfaction in hemodialysis patients
Design
The current study is a simple randomized clinical trial without blinding that will be conducted on 60 patients undergoing hemodialysis.60 cards are placed in a sealed envelope.
Settings and conduct
The current study is a randomized clinical trial study without blinding, which will be conducted on 60 hemodialysis patients referred to Vali Asr Fasa Hospital in the south of Fars province.
Participants/Inclusion and exclusion criteria
Participants will be hemodialysis patients.The criteria for inclusion in the study include: willingness to participate in the study, being literate in reading and writing, and having at least 6 months of hemodialysis experience. Exclusion criteria include absence of more than two sessions in training sessions, exacerbation and worsening of the disease condition, and unwillingness to continue participating in the study for any reason.
Intervention groups
The intervention group (30 people) will receive interdisciplinary training.The control group will not receive the training intervention and will only receive the training package.
Main outcome variables
Self-efficacy and life satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190917044802N11
Registration date:2024-01-21, 1402/11/01
Registration timing:registered_while_recruiting
Last update:2024-01-21, 1402/11/01
Update count:0
Registration date
2024-01-21, 1402/11/01
Registrant information
Name
Mostafa Bijani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5331 5012
Email address
bizhani_mostafa@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-04-18, 1403/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of interdisciplinary training on self-efficacy and life satisfaction in hemodialysis patients
Public title
Investigating the effect of interdisciplinary training on self-efficacy and life satisfaction in hemodialysis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Being literate in reading and writing
Having at least 6 months of hemodialysis experience
Exclusion criteria:
Absence of more than two sessions in training sessions
Aggravation and worsening of the disease
Unwillingness to continue participating in the study for any reason
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
60 cards are placed in a sealed envelope. 30 cards are put on stickers (A intervention group) and labels are placed on other 30 cards (B control group). Then the patients participating in the study are asked to take one of the cards. People who take card A will be in the intervention group and people who take card B will be in the control group.
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 Fasa University of Medical Sciences
Street address
Ibn Sina Square
City
Fasa
Province
Fars
Postal code
7461686688
Approval date
2023-12-26, 1402/10/05
Ethics committee reference number
IR.FUMS.REC.1402.142
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease
Primary outcomes
1
Description
Self- Efficacy
Timepoint
Before, immediately and three months after the educational intervention
Method of measurement
Sherer's General Self-Efficacy Questionnaire
2
Description
Life satisfaction
Timepoint
Before,immediately and three months after the educational intervention
Method of measurement
Diener life satisfaction questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: The interdisciplinary training program will be designed and implemented in the form of 5 sessions for the intervention group. The duration of each session will be 2 hours. In the first session, chronic kidney failure disease, its cause, aggravating factors of this disease will be taught, in the second session, the complications of chronic kidney failure disease, its effects on life, aggravating factors and factors that improve and reduce complications will be taught. . In the third session, recommendations related to nutrition, fluids, drugs and sexual education will be given to patients. In the fourth session, trainings related to assistance (guidance and introduction of clients to receive medical facilities to affiliated medical centers and help to solve the economic problem of sick clients in paying medical expenses, as well as, if necessary, communication with charities, relief committees or welfare organizations) and Also, spiritual issues (the purpose of one's life, belief in the other world and trust and faith in God) will be taught to the patients, and in the fifth session, psychological issues (mental-psychological problems that these patients face and psychological support- Patients' social skills) will be taught to patients.
Category
Lifestyle
2
Description
Control group: The control group will only receive the training package and will not receive the training intervention.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr Fasa Hospital
Full name of responsible person
Mostafa Bijani
Street address
Ibn Sina Square
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 917 330 8451
Email
bizhani_mostafa@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Ali Akbar Farjadfar
Street address
Ibn Sina Square
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 912 176 9752
Email
farjadfar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina Square
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Email
bizhani_mostafa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina Square
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Email
bizhani_mostafa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina square
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Email
bizhani_mostafa@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All the questionnaires used in this study as well as the content of the training program will be provided to the applicants.
When the data will become available and for how long
The time period for accessing the data is after the publication of the article extracted from the study and there is no time limit.
To whom data/document is available
Researchers, nursing managers and hospital management can send their request to use the results of this research to the responsible author Mostafa Bijani in writing.
Tell: 09173308451 Email:bizhani_mostafa@yahoo.com
Under which criteria data/document could be used
Nursing managers in the psychiatric department can use the results of this research to develop training programs for patients and patients' families.
From where data/document is obtainable
Researchers can send their request to use the results of this research to the responsible author Mostafa Bijani in writing.
Tell: 09173308451 Email:bizhani_mostafa@yahoo.com
What processes are involved for a request to access data/document
Sending the request for the use of research documents and results to the responsible author and sending the results by the responsible author to the requesting person
Tell: 09173308451 Email:bizhani_mostafa@yahoo.com