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IRCT20221211056774N1 IRCT 2022-12-15 Arak University of Medical Sciences The effect of family-centered training from distance on quality of life and sleep quality The effect of family-centered training from distance on quality of life and sleep quality in multiple sclerosis patients 2023-01-11 anticipated 70 Complete https://irct.ir/trial/67379 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: At first, samples will be selected as available.Then, patients will be divided into two control and intervention groups using permutation block randomization. According to the sample size, blocks with a capacity of 4 units will be considered. By assigning the letter A to the intervention group and the letter B to the control group, there are six states AABB, BBAA, BABA, ABBA, BAAB and ABAB. Then it is randomly selected from among these situations and a list equal to the sample size is prepared for patients before the start of the study .For better randomization, the web software will be used to prepare the randomization list, which creates random permutations for both types of treatment in each block, and according to the change of permutations in each block, concealment is also observed. During the implementation of the study, the predictability of the treatment for each patient is reduced by the researcher. Site used for random permutation block method: https://www.sealedenvelope.com/simple-randomiser/v1/lists. N/A Multiple sclerosis. Intervention 1: Intervention group: The members of the intervention group who are active members of the family will be members of WhatsApp and Telegram groups managed by the researcher, and educational content will be provided to them in the form of text.The researcher will answer the family member's questions in this way or by phone call. During the delivery of educational content, the researcher will ensure that the messages are read and viewed, by calling members and asking a few questions throughout the week. In the intervention group, educational content will be provided to the members twice a week for 6 weeks (generally 12 sessions) and they will be contacted by phone once a week. Intervention 2: Control group: The control group will receive only routine community support. In order to comply with ethical considerations, at the end of the research, the members of the control group will also become its members to use the educational content of social networks. 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 There is no further information
public Fatemeh Hashemi
Second floor, Nursing College, Arak University of Medical Sciences, Basij Squere, Sardasht
Arak Iran (Islamic Republic of) 3819693345 +98 86 3313 6055 F.hashemii1991@gmail.com Arak University of Medical Sciences scientific Moloud Farmahini Farahani
Second floor, Faculty of Nursing, Arak University of Medical Sciences, Basij Square
Arak Iran (Islamic Republic of) 3819693345 +98 86 3313 6055 farmahini70@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Completing the consent form of patients to participate in the study A definite diagnosis of multiple sclerosis for at least 6 months by a neurologist Age between 18-65 years Living with family Not having a private nurse Not receiving the same intervention at the same time Not having hearing, vision and speech problems No use of Psychiatric and sleeping drugs Not having a psychological problem Not suffering from other debilitating diseases Entry criteria for an active family member include completing the consent form to participate in the study Age over 18 years Having minimum literacy to read and write Living with the patient and being a member of the patient's family (father, mother, sister, brother, child and spouse) Access to smart phones, internet and social networks and the ability to work with them 18 years 65 years Both Death of the patient or active family member during the study Long-term hospitalization Failure to complete study questionnaires or filling them incompletely Unwillingness to continue cooperation Death of a family member in the last 6 months G35 Lifestyle Lifestyle Intervention group: The members of the intervention group who are active members of the family will be members of WhatsApp and Telegram groups managed by the researcher, and educational content will be provided to them in the form of text.The researcher will answer the family member's questions in this way or by phone call. During the delivery of educational content, the researcher will ensure that the messages are read and viewed, by calling members and asking a few questions throughout the week. In the intervention group, educational content will be provided to the members twice a week for 6 weeks (generally 12 sessions) and they will be contacted by phone once a week. Control group: The control group will receive only routine community support. In order to comply with ethical considerations, at the end of the research, the members of the control group will also become its members to use the educational content of social networks. Quality of life. Timepoint: Before the start of the intervention and 30 days after the end of the intervention. Method of measurement: Multiple sclerosis Quality of life questionnaire for MS patients(MSIS-29). Sleep quality. Timepoint: Before the start of the intervention and 30 days after the end of the intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Arak University of Medical Sciences Approved 2022-12-10 Ethics committee of Arak University of Medical Sciences Management of Research and Medical Information, Deputy of Research and Technology, University Complex of the Prophet (pbuh), Basij Square Arak Markazi Iran (Islamic Republic of)