]>
IRCT20210824052281N1 IRCT 2021-09-13 Tehran University of Medical Sciences The effect of empowerment program on self-management of patients with Multiple sclerosis The effect of patient-centered empowerment program through tele-nursing on self-management of patients with Multiple sclerosis 2021-09-24 anticipated 90 Complete https://irct.ir/trial/58331 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The allocation of samples to the two groups will be by block random allocation method and will be divided into two groups of intervention and control. Due to the sample size, 23 blocks of 4 are required for random block allocation. The intervention group will be displayed by A and the control group with B. Blocks of size 4 can have six modes 1AABB 2-ABAB 3-ABBA 4-BBAA 5BABA 6-BAAB. Then, we roll the dice, for example, 4 comes, it becomes BBAA. We roll the dice again, and for instance, 5 comes BABA, and ... we repeat and roll the dice until all the samples are allocated. In order to re-hide the random specification from the researcher, we will have a dark envelope with the sample size and number the envelopes as the sample size, in such a way that envelope number one is 1 and so on. Each random sequence created will be recorded on a card, placed inside the envelope, and finally pasted into the envelopes. At the time of enrollment in the study, according to the order of arrival of the samples, one of the envelopes will be opened in order and the group of the sample will be determined, Blinding description: On the one hand, there is blindness to the research community that these people will not find out that they are in the experimental group or in the control group. The allocation for these individuals will be random and they will not be told that they are in the test or control group. The other side that will be blind is the person who will perform the statistical analysis and will not find out whether the data obtained belong to the experimental group or the control group. N/A Multiple sclerosis. Intervention 1: Intervention group: In the intervention group, individuals in 5 main training sessions over 5 weeks will recieve empowerment program designed in physical dimensions that include: nutrition and diet, sleep, physical activity and exercise, fatigue management, movement problems, pain, body temperature control, vaccination, unhealthy habits (alcohol consumption, smoking) and women's health (menstrual cycle, menopause) in the first and second sessions, topics related to psychological dimensions that include: stress and anxiety management, mood control and management, problem solving skills, promoting resilience and life satisfaction in the third and fourth sessions and finally the topics related to social dimensions that include: employment, participation in society and social performance, lifestyle at home, free time, friendship and relationship, identification of family needs (role structure, responsibilities, goals, etc.) in the fifth session. After these main training sessions, counseling sessions will be held for two weeks according to the needs of each patient. The number of these sessions will vary according to the conditions and needs of each patient. After 8 weeks from the end of the intervention, post-test will be performed and finally the data before and after the intervention will be analyzed and evaluated using the Multiple Sclerosis Self-Management Scale–Revised. Intervention 2: Control group: Control group: The control group will receive the routine care of the Iran MS Society and at the end of the intervention, educational content will be provided to them. Yes - There is a plan to make this available What will be shared: Considering that the present study is an academic dissertation and a copy of it is provided to Tehran University of Medical Sciences; Therefore, all data can be shared after being unidentified. When: Access to the documentation of this study begins three months after the results are published. To whom: Data and documentation of this study will be available for researchers working in academic and scientific institutions. Conditions: All researchers working in scientific and academic centers, including researchers in multiple sclerosis centers, professors, students of nursing, all medical and paramedical degrees, nurses working in hospitals and community health centers, doctors, educational and research officials of multiple sclerosis centers and individuals workers in other paramedical disciplines are allowed to request unidentified data from this study. The use of the documents of this study can be used for all the mentioned groups only by mentioning the source and without any interference in its texts. Where to obtain: Considering that a copy of the dissertation will be provided to the library of the School of Nursing and Midwifery of Tehran University of Medical Sciences; Therefore, clients can visit the library of this center in person at: Tohid Square, Dr. Mirkhani St. (Eastern Nusrat), School of Nursing and Midwifery, Tehran University of Medical Sciences; Phone number: +982166927171; Or visit the library site of Tehran University of Medical Sciences in absentia at http://lib.tums.ac.ir/ to benefit from the documents of this study. How to obtain: If you visit the library of the School of Nursing and Midwifery of Tehran University of Medical Sciences in person, the client can read the research documents in the library by introducing himself to the librarian and presenting a valid ID card. It should be noted that the client will not be allowed to take the document out of the library and take a photo of it. If you visit the library site of Tehran University of Medical Sciences in absentia, the client will enter a part of the study title in the search box and a summary of the present study will be displayed for him. Comments:
public Fateme Bayat
Tohid Square, Dr. Mirkhani St. (Nosrat Sharghi), School of Nursing and Midwifery, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 f-bayat@razi.tums.ac.ir Tehran University of Medical Sciences scientific Fateme Bayat
Tohid Square, Dr. Mirkhani St. (Nosrat Sharghi), School of Nursing and Midwifery, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 f-bayat@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of MS for at least 6 months Age range 18 to 60 years Use of phone and smartphone 18 years 60 years Both Reluctance to participate in research Other physical or mental illness Cognitive or psychological disorders (self-expression and patient record) G35 Multiple sclerosis Rehabilitation Other Intervention group: In the intervention group, individuals in 5 main training sessions over 5 weeks will recieve empowerment program designed in physical dimensions that include: nutrition and diet, sleep, physical activity and exercise, fatigue management, movement problems, pain, body temperature control, vaccination, unhealthy habits (alcohol consumption, smoking) and women's health (menstrual cycle, menopause) in the first and second sessions, topics related to psychological dimensions that include: stress and anxiety management, mood control and management, problem solving skills, promoting resilience and life satisfaction in the third and fourth sessions and finally the topics related to social dimensions that include: employment, participation in society and social performance, lifestyle at home, free time, friendship and relationship, identification of family needs (role structure, responsibilities, goals, etc.) in the fifth session. After these main training sessions, counseling sessions will be held for two weeks according to the needs of each patient. The number of these sessions will vary according to the conditions and needs of each patient. After 8 weeks from the end of the intervention, post-test will be performed and finally the data before and after the intervention will be analyzed and evaluated using the Multiple Sclerosis Self-Management Scale–Revised. Control group: Control group: The control group will receive the routine care of the Iran MS Society and at the end of the intervention, educational content will be provided to them. Self-management score on The Multiple Sclerosis Self-Management Scale–Revised. Timepoint: At the beginning of the study (before the start of the intervention) and after 8 weeks from the end of the intervention. Method of measurement: The Multiple Sclerosis Self-Management Scale–Revised. Tehran University of Medical Sciences Approved 2021-07-26 Ethics Committee of the School of Nursing and Midwifery and the School of Rehabilitation, Tehran Uni North Kargar St., 16th St., Alley Complex, Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)