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IRCT20231114060052N1 IRCT 2023-12-10 Shiraz University of Medical Sciences the effect of implementing self-compassion training program on self-compassion, adherence to treatment and anxiety of patients with multiple sclerosis the effect of implementing self-compassion training program on self-compassion, adherence to treatment and anxiety of patients with multiple sclerosis 2023-10-23 anticipated 80 Complete https://irct.ir/trial/73751 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After obtaining written consent from the patient's legal guardian, they were assigned to two intervention and control groups by random allocation method and using permutation blocks. Considering that two groups are considered in the study, patients were allocated in six cases of blocks of four. (A care program group and B control group, for example AABB, ABAB, BBAA,...). There were two people from each group in each block. The order of the blocks was randomly determined using a table of random numbers, and then the patients were assigned to the intervention or control group based on the blocks. In this way, the researcher interviewed the patient, for each of the participants, the subject of the research, the objectives, the stages of the research, the voluntary nature of the participation in this research and the confidentiality of the information were explained, and finally, a written consent form was obtained from the patient or family and explained to the samples. It was given that they have the freedom to leave and continue the study, their non-participation or withdrawal will not affect their treatment, Blinding description: The patients of the MS center did not know which group they were in (intervention or control) and the training sessions were held in another place where they had no contact with the control group. N/A multiple sclerosis. Intervention 1: Intervention group: eight 45-minute sessions that were conducted in the form of an eight-day workshop twice a week for four weeks to the patients (in the MS Association of Zahedan) by a researcher and a consultant under the supervision of research team members and a neurologist. Session 1: Acquaintance and awareness: talk about the purpose of the meeting and its overall construction, (goal: checking the expectations of the treatment plan, getting to know the general principles of compassion-focused treatment. Explaining the disease, its causes, symptoms, methods treatment, diagnostic methods and complications of multiple sclerosis). Session 2: Introduction of self-compassion and self-criticism. (Aim: review of the previous session and review of how members deal with themselves (critical and self-compassionate style). Definition of self-criticism and its causes and consequences. Session 3: Introduction of the characteristics and skills of compassion. self and how it affects the mental states of the person, (purpose: review the assignment and review of the previous session; what is self-compassion? examining its characteristics and skills and how it affects the mental states of the person, introducing the three emotional regulation systems and how to interact with them Session 4: Introduction to mental imagery, (goal: Reviewing the assignment and review of the previous session introducing mental imagery and its logic. Teaching imagery practice and its implementation in the group (Imagination of color, place and characteristics of a compassionate person). Session 5: Education self-compassion and introduction of concepts: wisdom, ability, warmth and responsibility (goal: checking the assignment and review of the previous session; cultivating self-compassion and introduction of concepts: wisdom, ability, warmth and responsibility-responsibility in creating compassion, teaching how to portray about self-compassion).Session 6: Teaching self-compassion letter writing (goal: checking the assignment and reviewing the previous session of teaching self-compassion letter writing).Session 7: Explaining the fear of self-compassion and identifying thoughts that prevent the development of self-compassion (goal: Examining the assignment and review of the previous session fear of compassion to self-identify thoughts preventing the development of compassion for oneself and the user on them). their results from the group). Intervention 2: Control group: they will not receive education except usual care and at the same time interval as the intervention group, the post-test will also be done from the control group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The research team is very busy
public Farshid Saidinezhad
Golestan town, Farsh street, address 15
shiraz Iran (Islamic Republic of) 07189740003 +98 71 3342 2567 farshidsaeedinezhad@gmail.com Shiraz University of Medical Sciences scientific Farshid Saeedinezhad
Golestan town, Farsh street, Address 15
Shiraz Iran (Islamic Republic of) 7189740003 +98 71 3342 2567 FARSHIDSAEEDINEZHAD@GMAIL.COM Shiraz University of Medical Sciences Iran (Islamic Republic of) The research sample in this study included all patients with multiple sclerosis, members of the Multiple Sclerosis Association of Zahedan city, whose disease was confirmed by a neurologist and at least 6 months had passed since the diagnosis of their disease. no limit no limit Both Occurrence of serious complications of the disease (severe movement disorder, vision), hospitalization or death of the patient during the study. Absence of more than one session in the workshop. G37.9 Demyelinating disease of central nervous system, unspecified Lifestyle Lifestyle Intervention group: eight 45-minute sessions that were conducted in the form of an eight-day workshop twice a week for four weeks to the patients (in the MS Association of Zahedan) by a researcher and a consultant under the supervision of research team members and a neurologist. Session 1: Acquaintance and awareness: talk about the purpose of the meeting and its overall construction, (goal: checking the expectations of the treatment plan, getting to know the general principles of compassion-focused treatment. Explaining the disease, its causes, symptoms, methods treatment, diagnostic methods and complications of multiple sclerosis). Session 2: Introduction of self-compassion and self-criticism. (Aim: review of the previous session and review of how members deal with themselves (critical and self-compassionate style). Definition of self-criticism and its causes and consequences. Session 3: Introduction of the characteristics and skills of compassion. self and how it affects the mental states of the person, (purpose: review the assignment and review of the previous session; what is self-compassion? examining its characteristics and skills and how it affects the mental states of the person, introducing the three emotional regulation systems and how to interact with them Session 4: Introduction to mental imagery, (goal: Reviewing the assignment and review of the previous session introducing mental imagery and its logic. Teaching imagery practice and its implementation in the group (Imagination of color, place and characteristics of a compassionate person). Session 5: Education self-compassion and introduction of concepts: wisdom, ability, warmth and responsibility (goal: checking the assignment and review of the previous session; cultivating self-compassion and introduction of concepts: wisdom, ability, warmth and responsibility-responsibility in creating compassion, teaching how to portray about self-compassion).Session 6: Teaching self-compassion letter writing (goal: checking the assignment and reviewing the previous session of teaching self-compassion letter writing).Session 7: Explaining the fear of self-compassion and identifying thoughts that prevent the development of self-compassion (goal: Examining the assignment and review of the previous session fear of compassion to self-identify thoughts preventing the development of compassion for oneself and the user on them). their results from the group) Control group: they will not receive education except usual care and at the same time interval as the intervention group, the post-test will also be done from the control group Adherence to treatment and anxiety. Timepoint: Start studying, 1 and 3 months later. Method of measurement: questionnaire. Shiraz University of Medical Sciences Approved 2023-09-09 National system of ethics Golestan town, Farsh street, address 15 SHIRAZ Fars Iran (Islamic Republic of)