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IRCT20260718070239N1 IRCT 2026-09-13 Tehran University of Medical Sciences The Effect of Self-Care Education on Self-Compassion and Psychological Hardiness in Patients with Multiple Sclerosis The effect of self-care education based on psychological well-being on self-compassion and Psychological Hardiness in patients with multiple sclerosis 2026-08-23 anticipated 40 Recruiting https://irct.ir/trial/91840 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Other design features: , 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 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. N/A Multiple Sclerosis(MS). Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is 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.
public Abolfazl Ramezani
No. 3, Nofallah Student Dormitory, Corner of Vaziri Alley, Nofallah Street, Enghelab Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1313813178 +98 917 657 9361 ab.ramezani1379@gmail.com Tehran University of Medical Sciences scientific Abolfazl Ramezani
No. 3, Nofallah Student Dormitory, Corner of Vaziri Alley, Nofallah Street, Enghelab Square, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1313813178 +98 917 657 9361 ab.ramezani1379@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 60 years Both 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. G35 Multiple sclerosis (G35) Behavior Behavior 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. 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. 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. 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. Tehran University of Medical Sciences Approved 2026-07-10 Research Ethics Committee of the School of Nursing and Midwifery and the School of Rehabilitation, T No. 3, Nofallah Student Dormitory, Corner of Vaziri Alley, Nofallah Street, Enghelab Square, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)