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the effect of implementing self-compassion training program on self-compassion, adherence to treatment and anxiety of patients with multiple sclerosis

Protocol summary

Study aim
Investigating the effect of implementing an educational program on self-compassion and adherence to treatment in patients with multiple sclerosis
Design
The order of the blocks was determined randomly using a table of random numbers, and then the patients will enter the intervention or control group based on the blocks.
Settings and conduct
The program is in the form of 8 sessions during which the self-compassion program will be given theoretically and practically to the patients of the intervention group. The classes schedule will be informed to the samples and they were reminded that participation in all sessions is not mandatory After one and three months of the implementation of the educational intervention, the post-test will be conducted and the questionnaires will be completed again. The control group will not receive education except usual care
Participants/Inclusion and exclusion criteria
1- The definitive diagnosis of multiple sclerosis 2- Minimum literacy is a diploma. 3- No history of joint problems, no previous contraction and deformation in joints and neuro-muscular disorders.
Intervention groups
Considering the answers given to the forms and questionnaires by the patients, the designed self-compassion program was implemented. This program was in the format of 8 sessions and the average duration of the sessions was 45 minutes, during which the self-compassion program was theoretically and practically given to the patients of the intervention group, and during three months for the implementation of those patients through the presence of the researcher at the association and with Telephone follow-ups are supported
Main outcome variables
Adherence to treatment and anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231114060052N1
Registration date: 2023-12-10, 1402/09/19
Registration timing: registered_while_recruiting

Last update: 2023-12-10, 1402/09/19
Update count: 0
Registration date
2023-12-10, 1402/09/19
Registrant information
Name
farshid saeedinezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3342 2567
Email address
farshidsaeedinezhad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of implementing self-compassion training program on self-compassion, adherence to treatment and anxiety of patients with multiple sclerosis
Public title
the effect of implementing self-compassion training program on self-compassion, adherence to treatment and anxiety of patients with multiple sclerosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National system of ethics
Street address
Golestan town, Farsh street, address 15
City
SHIRAZ
Province
Fars
Postal code
07189470003
Approval date
2023-09-09, 1402/06/18
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1402.072

Health conditions studied

1

Description of health condition studied
multiple sclerosis
ICD-10 code
G37.9
ICD-10 code description
Demyelinating disease of central nervous system, unspecified

Primary outcomes

1

Description
Adherence to treatment and anxiety
Timepoint
Start studying, 1 and 3 months later
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
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)
Category
Lifestyle

2

Description
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
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Zahedan city MS center
Full name of responsible person
Ali Raza Durrani
Street address
Amirul Mominin Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817697739
Phone
+98 54 3343 5548
Fax
+98 54 3343 5548
Email
F_S200669@YAHOO.COM

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Zand St
City
SHIRAZ
Province
Fars
Postal code
۷۱۴۶۸۶۴۶۸۵
Phone
+98 71 3235 7282
Fax
+98 71 3235 7282
Email
hashempurm@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Farshid Saidinezhad
Position
student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Golestan town, Farsh street, address 15
City
shiraz
Province
Fars
Postal code
07189740003
Phone
+98 71 3342 2567
Email
farshidsaeedinezhad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farshid Saeedinezhad
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Golestan town, Farsh street, Address 15
City
Shiraz
Province
Fars
Postal code
7189740003
Phone
+98 71 3342 2567
Email
FARSHIDSAEEDINEZHAD@GMAIL.COM

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahnaz Rakhshan
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
prayer square
City
SHIRAZ
Province
Fars
Postal code
۷۱۹۳۶۱۳۱۱۹
Phone
+98 71 3647 4254
Email
rakhshanm@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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 personal information is kept confidential
When the data will become available and for how long
2024
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Free access to the statistical data of this study will be given
From where data/document is obtainable
Vice President of Research and Technology of Shiraz University of Medical Sciences
What processes are involved for a request to access data/document
A written request from the Deputy of Research and Technology of Shiraz University of Medical Sciences
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