The effect of multimedia education based on stress management program on quality of life and self-care behaviors of hemodialysis patients: a parallel randomized clinical trial
Evaluation of the efficacy multimedia education based on stress management program on quality of life and self-care behaviors of hemodialysis patients
Design
Superiority clinical trial, randomized controlled trial, using a random blocking allocation that cannot be blinded and a sample size will 64 people.
Settings and conduct
The places of implementation of the study are Imam Hossein Hospital in Shahrood and Imam Reza Hospital in Mashhad. Multimedia training based on the stress management program, including 6 training sessions in the form of sending multimedia content within a month. World Health Organization's quality of life questionnaire and Miller's self-care behavior questionnaire are completed by both groups at the beginning and one month after the end of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years, definitive diagnosis of end-stage renal disease by a specialist, ability to use a smartphone, history of at least 1 year of hemodialysis, undergoing hemodialysis 2-3 times a week. Exclusion criteria: Suffering from mental disorders, taking neuroleptic drugs, the occurrence of traumatic events for the patient less than six months before the intervention.
Intervention groups
The intervention group will undergo six training sessions, delivered through the circulation of multimedia content within online groups comprising 3 to 5 individuals. The educational support component encompasses three sessions dedicated to matters related to hemodialysis, while the psychological domain incorporates three sessions focusing on stress management, guided by Lazarus and Folkman's theory. Meanwhile, individuals in the control group will receive standard training related to the treatment center.
Main outcome variables
Self-care behaviors, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180728040617N10
Registration date:2024-02-12, 1402/11/23
Registration timing:prospective
Last update:2024-02-12, 1402/11/23
Update count:0
Registration date
2024-02-12, 1402/11/23
Registrant information
Name
Seyedmohammad Mirhosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 3811
Email address
mirhoseinim@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-08, 1403/01/20
Expected recruitment end date
2024-08-21, 1403/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of multimedia education based on stress management program on quality of life and self-care behaviors of hemodialysis patients: a parallel randomized clinical trial
Public title
The effect of multimedia education based on stress management program on quality of life and self-care behaviors of hemodialysis patients: a parallel randomized clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years
Definitive diagnosis of end stage renal disease by a specialist
Ability to use a smartphone
Experience of at least 1 year of hemodialysis
Undergoing hemodialysis 2 to 3 times a week
Exclusion criteria:
Having psychiatric disorders
Neuroleptics medications
Occurrence of traumatic events for the patient less than six months before the intervention
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention and control groups by random block allocation using quadruple blocks created by SPSS software. According to the sample size of 64 in the present study, 16 quadruple blocks will be considered. Each patient will be randomly assigned to Group A (intervention) or B (control group) in the order determined by the software, and the allocation and sampling process will be performed sequentially until sampling is completed. Individuals are assigned to the target group in order of their entry into the study and randomly through randomized blocks.
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 Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Tehran St., Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3614773955
Approval date
2024-01-10, 1402/10/20
Ethics committee reference number
IR.SHMU.REC.1402.168
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
Y84.1
ICD-10 code description
Kidney dialysis as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
Quality of Life
Timepoint
At the beginning of the study (before the intervention) and a month after intervention.
Method of measurement
World Health Organization Quality of Life Questionnaire
2
Description
Self-care behaviors
Timepoint
At the beginning of the study (before the intervention) and a month after intervention.
Method of measurement
Miller self-care behavior questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will participate in six online sessions featuring multimedia educational content. This content includes educational support covering hemodialysis, diet, medications, and physical activity, along with a stress management program based on Lazarus and Folkman's theoretical model. The stress management program will encompass education on stress and its influencing factors, assistance for patients in identifying counterproductive stress-inducing thoughts, provision of problem-oriented and emotion-oriented solutions for managing stress, and support for the application of stress management techniques in daily life.Data Collection Tools: Data collection tools will include a demographic information form, the Miller Self-Care Behavior Questionnaire, and the World Health Organization Quality of Life Questionnaire. These questionnaires will be completed by all patients (both the intervention and control groups) before the intervention, prior to the first session. Subsequently, one month after the conclusion of the intervention, the same questionnaires will be completed to assess the effectiveness of the intervention.
Category
Other
2
Description
Control group: The control group will receive routine support from the treatment center. Supportive content will be provided to the control group after the intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Seyedmohammad Mirhosseini
Street address
Imam Hossein Hospital, Emam St., Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
smohammadmh@gmail.com
2
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Hamid Reza Zendehtalab
Street address
Imam Reza Hospital, Imam Reza Sq ,Ebnesina St. Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 3772
Email
zendehtalabhr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Behzad Garmabi
Street address
Shahroud University of Medical Sciences, Tehran St., Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
Garmabi@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Sara Khajoei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences, Tehran St., Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
sara13721400@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Ali Abbasi
Position
Assistant professor of nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences, Tehran St., Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
abbasi_msn@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Seyedmohammad Mirhosseini
Position
Instructor of nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahroud University of Medical Sciences, Tehran St., Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
smohammadmh@gmail.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
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Certain demographic information of patients can be shared after de-identifying the individuals. Additionally, all data related to assessing the quality of life and self-care behaviors of patients can also be shared after unidentified individuals.
When the data will become available and for how long
After publishing the article
To whom data/document is available
Project partners
Under which criteria data/document could be used
People who do similar research.
From where data/document is obtainable
Requests to receive documents are sent to the project's principal investigator (Ali Abbasi) via email (abbasi_msn@yahoo.com). Address: Tehran St., Shahroud University of Medical Sciences, Shahroud, Iran. Contact number: 00982332395054, postal code: 3614773955
What processes are involved for a request to access data/document
After receiving the request, the data will be provided to the applicants by the project manager immediately via email.