1. Home
  2. Approved trials
  3. » فارسی

The effect of self-care education based on psychological well-being on self-compassion and Psychological Hardiness in patients with multiple sclerosis

Protocol summary

Study aim
The Effect of Self-Care Education Based on Psychological Well-Being on Self-Compassion and Psychological Hardiness in Patients with Multiple Sclerosis
Design
This is a single-blind randomized controlled trial involving 40 patients with multiple sclerosis. Participants will be allocated in a 1:1 ratio to intervention and control groups using block randomization with a block size of 4. Allocation concealment will be performed using numbered, opaque, sealed envelopes
Settings and conduct
A single-blind randomized controlled trial of 40 patients with multiple sclerosis. Participants will be allocated to intervention or control groups using block randomization. The intervention includes seven 60-minute self-care education sessions based on psychological well-being, with blinded outcome assessment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Confirmed multiple sclerosis, ≥6 months since diagnosis, no psychiatric disorders, adequate cognitive ability to understand the educational content and complete questionnaires, Persian literacy, and informed consent. Exclusion criteria: Cognitive impairment or disabling conditions affecting participation or questionnaire completion, severe psychiatric disorders affecting participation or responses, and concurrent similar educational or psychological interventions affecting self-compassion or psychological hardiness
Intervention groups
The intervention group consists of patients with multiple sclerosis who will receive a structured self-care education program based on Carol Ryff’s model of psychological well-being in seven educational sessions, with each session lasting 60 minutes. The comparison (control) group consists of patients with multiple sclerosis who will receive their usual care throughout the study period.
Main outcome variables
Change in self-compassion score; Change in psychological hardiness score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260718070239N1
Registration date: 2026-09-13, 1405/06/22
Registration timing: registered_while_recruiting

Last update: 2026-09-13, 1405/06/22
Update count: 0
Registration date
2026-09-13, 1405/06/22
Registrant information
Name
Abolfazl Ramezani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 657 9361
Email address
ab.ramezani1379@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-08-23, 1405/06/01
Expected recruitment end date
2026-12-22, 1405/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care education based on psychological well-being on self-compassion and Psychological Hardiness in patients with multiple sclerosis
Public title
The Effect of Self-Care Education on Self-Compassion and Psychological Hardiness in Patients with Multiple Sclerosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of a psychiatric disorder by a physician, medical records, or self-report Lack of a confirmed diagnosis of multiple sclerosis Less than six months since the diagnosis of multiple sclerosis Lack of sufficient cognitive ability to understand the educational content and complete the questionnaires Inability to read and write in Persian language Willingness and informed consent to participate in the study
Exclusion criteria:
Presence of cognitive impairment that prevents the participant from understanding the educational content or completing the research instruments. Presence of a disabling illness or a self-reported condition that prevents effective participation in the educational sessions. Presence of severe psychiatric disorders that may affect the participant's participation in the intervention or ability to respond to the research instruments. Concurrent participation in similar educational programs or psychological interventions that may affect the participant's self-compassion or psychological hardiness.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The unit of randomization in this study will be the individual participant. A total of 40 eligible participants, after meeting the inclusion criteria and providing written informed consent, will be allocated to either the intervention or control group. Block randomization with a fixed block size of four will be used, with two participants allocated to the intervention group and two participants allocated to the control group within each block. Given two study groups and a block size of four, six possible allocation sequences exist: ABAB, AABB, BABA, BBAA, ABBA, and BAAB, where A represents the intervention group and B represents the control group. Based on the sample size of 40 participants, a total of 10 blocks of four participants will be required. The sequence of blocks will be generated randomly using Randomization.com. Stratified randomization will not be used in this study. After generating the random allocation sequence, allocation concealment will be ensured by placing the group assignment for each participant in sequentially numbered, opaque, sealed envelopes. The envelopes will be opened sequentially according to the order in which eligible participants enter the study, only after completion of the enrollment process and provision of informed consent. The assigned group for each participant will then be determined. Therefore, the allocation sequence will remain concealed until the participant has been definitively enrolled in the study, preventing prior knowledge of the assigned group
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, blinding will be implemented at the outcome assessor level. The outcome assessor will be unaware of the participants' group allocation, and information regarding group assignment will not be disclosed to the outcome assessor. The assessment and evaluation of study outcomes at different stages of the study will therefore be conducted without the outcome assessor being aware of whether participants belong to the intervention or control group.
Placebo
Not used
Assignment
Other
Other design features
....................

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of the School of Nursing and Midwifery and the School of Rehabilitation, T
Street address
No. 3, Nofallah Student Dormitory, Corner of Vaziri Alley, Nofallah Street, Enghelab Square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1313813178
Approval date
2026-07-10, 1405/04/19
Ethics committee reference number
IR.TUMS.FNM.REC.1405.060

Health conditions studied

1

Description of health condition studied
Multiple Sclerosis(MS)
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis (G35)

Primary outcomes

1

Description
Self-compassion score measured by the Neff Self-Compassion Scale
Timepoint
Self-compassion will be measured before the start of the study, after completion of the seven educational sessions, and eight weeks after the completion of the study
Method of measurement
Self-compassion will be assessed using the 26-item Self-Compassion Scale developed by Kristin Neff and colleagues in 2003. This scale consists of six components, including self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification. The self-kindness component includes items 5, 12, 19, 23, and 26. The self-judgment component includes items 1, 8, 11, 16, and 21. The common humanity component includes items 3, 7, 10, and 15. The isolation component includes items 4, 13, 18, and 25. The mindfulness component includes items 9, 14, 17, and 22. The over-identification component includes items 2, 6, 20, and 24. To calculate the self-compassion score, the score of each component will be calculated separately, and the sum of these scores will be considered as the total self-compassion score. Responses will be rated on a 5-point Likert scale ranging from completely disagree = 1 to completely agree = 5. Higher scores indicate higher levels of self-compassion

2

Description
Psychological hardiness score measured by the Kobasa Psychological Hardiness Scale
Timepoint
Psychological hardiness will be measured before the start of the study, after completion of the seven educational sessions, and eight weeks after the completion of the study
Method of measurement
Psychological Hardiness Scale:Psychological hardiness will be assessed using the 20-item Psychological Hardiness Scale developed by Kobasa and colleagues in 1982. This scale consists of three components, including commitment, challenge, and control. The commitment component includes items 1 to 9, the control component includes items 10 to 16, and the challenge component includes items 17 to 20. To calculate the psychological hardiness score, the score of each component will be calculated separately, and the sum of these scores will be considered as the total psychological hardiness score. Responses will be rated on a 4-point Likert scale (never, rarely, sometimes, and often). Higher scores indicate higher levels of psychological hardiness

Secondary outcomes

empty

Intervention groups

1

Description
The intervention in this study consists of a structured self-care education program based on Carol Ryff’s model of psychological well-being, which will be delivered face-to-face by the researcher to participants in the intervention group.The program will be provided to 20 participants in seven educational sessions, with each session lasting 60 minutes, during the study period.The content of the sessions is as follows:Session 1: Introduction of group members, establishment of a therapeutic relationship, introduction to multiple sclerosis, the concept of self-care, the importance of self-care in disease management, and introduction to the concept of psychological well-being.Session 2: Education on self-awareness and identification of emotions, exploration of the relationship between thoughts, emotions, and behaviors, mindfulness training, and practice in identifying and recording emotions.Session 3: Education on values and meaning in life, exploration of the role of meaning and purpose in psychological well-being, introduction to the concept of self-compassion, and training in mindful breathing.Session 4: Education on positive relationships with others, the importance of social support in adaptation to the disease, identification of sources of social support, and self-compassion-related exercises.Session 5: Education on accepting personal responsibility for self-care and disease management, goal setting, strengthening the sense of control over one's life, and exploring barriers to self-care.Session 6: Training in problem-solving skills, identification and modification of dysfunctional thoughts, management of difficult emotions, and planning to achieve personal goals and maintain self-care.Session 7: Strengthening hope and motivation, promoting purposefulness and planning for continued self-care, practicing the expression of positive emotions, reviewing the content of previous sessions, summarizing the program, and answering participants' questions.The educational sessions will be delivered using various educational methods, including presentation of educational materials, lectures, group discussions, question-and-answer sessions, practical exercises, mindfulness and self-compassion exercises, feedback, and homework assignments. At the end of each session, an exercise or homework assignment related to the session content will be assigned to the participants and reviewed during the subsequent session. The educational content will be delivered by the researcher according to a predetermined educational program.
Category
Behavior

2

Description
Control group: Participants in the control group will receive their usual care throughout the study period and will not participate in the psychological well-being-based self-care education program. Usual care includes the services and care routinely provided to patients with multiple sclerosis by healthcare centers based on their disease condition and treatment plan. Participants in the control group will complete the study assessments and relevant questionnaires at the predetermined time points according to the study protocol.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Branch of the Iranian Multiple Sclerosis Society
Full name of responsible person
Abdolhossein Houshmand
Street address
Shahid Shams Alley, Vesal Shirazi Street, Near Taleghani Intersection, Enghelab Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
141686473
Phone
+98 917 657 9361
Fax
+98 21 6649 9514
Email
ab.ramezani1379@gmail.com
Web page address
https://www.iranms.org/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Research Office, School of Nursing and Midwifery, Tehran University of Medical Sciences
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Maryam Mirzakhani Street, Nosrat Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4567
Fax
Email
fnm-researchdeputy@tums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Abolfazl Ramezani
Position
Master’s Student in Psychiatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 3, Nofallah Student Dormitory, Corner of Vaziri Alley, Nofallah Street, Enghelab Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1313813178
Phone
+98 917 657 9361
Fax
Email
ab.ramezani1379@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abolfazl Ramezani
Position
Master's student in Psychiatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 3, Nofallah Student Dormitory, Corner of Vaziri Alley, Nofallah Street, Enghelab Square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1313813178
Phone
+98 917 657 9361
Email
ab.ramezani1379@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abolfazl Ramezani
Position
Master's student in Psychiatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 3, Nofallah Student Dormitory, Corner of Vaziri Alley, Nofallah Street, Enghelab Square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1313813178
Phone
+98 917 657 9361
Email
ab.ramezani1379@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to ethical considerations and protection of participants’ privacy, individual-level data will not be shared. The collected data will only be used for research purposes and will be reported in an aggregated and anonymous manner.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
...
When the data will become available and for how long
..
To whom data/document is available
..
Under which criteria data/document could be used
..
From where data/document is obtainable
..
What processes are involved for a request to access data/document
..
Comments
Loading...