Investigating the effect of implementing the family-centered empowerment model on psychological well-being and health-promoting lifestyle in multiple sclerosis patients
Determining the effect of implementing a family-centered empowerment model on psychological well-being and health-promoting lifestyle in multiple sclerosis patients
Design
This study is a randomized clinical trial without blinding.
Settings and conduct
This study is a randomized clinical trial without blinding that will be conducted at the Multiple Sclerosis Clinic at Vali Asr Hospital, Fasa University of Medical Sciences.
Participants/Inclusion and exclusion criteria
In this study, 60 multiple sclerosis patients will participate. Inclusion criteria include willingness to participate in the study, being literate, and having at least 6 months of multiple sclerosis history. Exclusion criteria include missing more than two sessions of educational sessions, exacerbation and worsening of the disease, and unwillingness to continue participating in the study for any reason.
Intervention groups
30 multiple sclerosis patients will be included in the intervention group.
Investigating the effect of implementing the family-centered empowerment model on psychological well-being and health-promoting lifestyle in multiple sclerosis patients
Public title
The effect of implementing the family-centered empowerment model on psychological well-being and health-promoting lifestyle in multiple sclerosis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Being literate in reading and writing
Having at least a 6-month history of multiple sclerosis
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
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
30
30 patients in the intervention group and 30 patients in the control group
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
2024-12-17, 1403/09/27
Ethics committee reference number
R.FUMS.REC.1403.115
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Psychological well-being
Timepoint
Before the intervention, immediately and three months after the intervention
Method of measurement
Ryff’s Psychological Well-Being Questionnaire
2
Description
Health Promoting Lifestyle
Timepoint
Before the intervention, immediately and three months after the intervention
Method of measurement
Walker et al. Health Promoting Lifestyle Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, a training program based on the family-centered empowerment model will be implemented. The stages of the family-centered empowerment model will include four stages: 1- Understanding the threat, 2- Improving self-efficacy, 3- Self-belief and increasing self-confidence, 4. Evaluation. Step one, Understanding the threat: The first stage in the family-centered empowerment model is to increase perceived severity and sensitivity. The purpose of perceived severity (awareness and knowledge of the individual about the disease) is for the individual to understand the seriousness of the disease by recognizing the risks or complications of the disease and to feel threatened by it. Step two, Self-efficacy: Problem solving or problem solving will be implemented in a group method. For this purpose, problem solving sessions (two 40- to 60-minute sessions) will be held for a group of patients and their families. Step three, Self-belief and increasing self-confidence: In this stage, the patient will be asked to teach the family the material discussed in the previous sessions during a session and to do this with the researcher's help and guidance if needed. The goal of this stage is to increase patients' self-confidence by observing their ability to provide information to family members and support them. Step Four, Evaluation: The evaluation of the process during the empowerment sessions will be carried out in such a way that the educational materials of the previous sessions are evaluated in the form of questions and answers in the next session.
Category
Lifestyle
2
Description
Control group: The control group will only receive the educational package and will not receive the educational intervention.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Multiple Sclerosis Clinic
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
Mojtaba Farjam
Street address
Ibn Sina Square
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 917 710 4789
Email
farjam@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
+98 917 330 8451
Email
bizhani_mostafa@yahoo.con
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
+98 917 330 8451
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
+98 917 330 8451
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
No - There is not 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