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IRCT20151107024919N11 IRCT 2020-10-22 Kerman University of Medical Sciences Effect of Guided Imagery on fatigue, stigma, and mood in patients with Multiple Sclerosis The study of effectiveness of Guided Imagery on fatigue, stigma, and mood in patients with Multiple Sclerosis 2020-07-22 anticipated 60 Complete https://irct.ir/trial/46899 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to allocate the subjects to the intervention and control groups,a randomized block method is used, Block randomization method is a method in which participants are randomly selected in terms of severity of fatigue, type of disease, duration of illness, numbers of recurrences per year, family history of the Multiple sclerosis disease, etc are placed in the blocks. Subsequently, through the use of a simple method and using R Test from each group, half of the subjects are placed in the intervention group and the other half are in the control group, Blinding description: Given that the intervention takes place at home; this study is double-blind. the data analyst do not know which data is related to the intervention group and which data is related to the control group, and participants do not know in which intervention or control group they were placed. N/A Multiple sclerosis. Intervention 1: Intervention group: In the intervention group, 48 sessions of guided imagery will be performed in 4 weeks and six sessions per week in two turns at the morning (between 08:00 and 09:00) and in the evening (between 20:00 and 21:00). Morning and evening sessions will be held at the patient's home. Patients will listen to the Audio- Recorded Guided Imagery Script for 25 minutes via headphone and will follow the instructions. Also, disturbing noises will be controlled through meetings formation in quiet rooms. Also at home, it is attempted to allocate a room for the patient to listen to the Audio-Recorded Guided Imagery Script with the coordination of the patient and the family. Intervention 2: Control group: Patients in the control group received routine cares. 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 reasercher deosnt have any interest to share because of ethical issue. (there is no further information)
public Batool Tirgari
Kerman University of Medical Sciences,Medical University of Campus, Haft- Bagh - alavi Highway, Kerman
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5207 b_tirgari@kmu.ac.ir Kerman University of Medical Sciences scientific Batool Tirgari
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5207 b_tirgari@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Full consciousness Acceptable ability to hear, see and speak Have ability to read and write in Persian language Diagnosis of Relapsing-Remitting Multiple Sclerosis by neurologist Getting a degree of fatigue less than average 6 based on Fatigue Severity Scale (FSS) questionnaire 18 years 70 years Both Use of sedatives, antidepressants and narcotics Existence of a history of mental illness and hospitalization continuously Getting other neurological disorders Previous experience use of relaxation techniques (including Guided Imagery) G35 Multiple sclerosis N/A N/A Intervention group: In the intervention group, 48 sessions of guided imagery will be performed in 4 weeks and six sessions per week in two turns at the morning (between 08:00 and 09:00) and in the evening (between 20:00 and 21:00). Morning and evening sessions will be held at the patient's home. Patients will listen to the Audio- Recorded Guided Imagery Script for 25 minutes via headphone and will follow the instructions. Also, disturbing noises will be controlled through meetings formation in quiet rooms. Also at home, it is attempted to allocate a room for the patient to listen to the Audio-Recorded Guided Imagery Script with the coordination of the patient and the family. Control group: Patients in the control group received routine cares. Fatigue. Timepoint: The severity of fatigue will be measured before and four weeks after the end of the intervention. Method of measurement: Fatigue severity scale. Stigma. Timepoint: The severity of stigma will be measured before and four weeks after the end of the intervention. Method of measurement: Reece Stigma Scale_Multiple Sclerosis. Mood. Timepoint: The severity of mood will be measured before and four weeks after the end of the intervention. Method of measurement: Profile Of Mood State. Kerman University of Medical Sciences Approved 2020-07-06 Ethics Committee of Kerman University of Medical Sciences Medical Center of the Special Diseases., No. 78 Alley., Shahid Rajaee Street., Kerman Kerman Iran (Islamic Republic of)