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IRCT20151107024919N15 IRCT 2023-09-01 Kerman University of Medical Sciences The Effect of Foot Reflexology on Restless leg syndrome and Sleep Quality The Effect of Foot Reflexology on Restless leg syndrome and Sleep Quality in Patients with Multiple Sclerosis 2023-07-31 anticipated 64 Complete https://irct.ir/trial/71552 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be divided into intervention and control groups by block randomization method. For this purpose, the block size of 4 is used; So that two participants will be placed in each of the intervention and control groups within each block, and R software is used for this. Block randomization method. Block randomization works by randomizing participants within blocks such that an equal number are assigned to each treatment.The block size is determined by the researcher and should be a multiple of the number of groups (i.e., with two treatment groups, block size of either 4, 6, or 8) The method used in this study is as follows: BABA"ABBA "AAB"BABA"BBAA" "BAAB "AAB "ABAB"BABA "AABB"BBAA"AABB "ABBA "BAAB"AABB", Blinding description: In this study, the participants and the statistician who will be responsible for data analysis will be blinded to the participants in the intervention and control groups. The data analyst does not know which data are related to the intervention group and which data are related to the control group. The information related to the intervention and control groups will be entered into SPSS software under the title of group 1 and group 2. The analyst will not know which of the groups 1 and 2 is the intervention and control groups.To avoid contamination between the intervention and control groups, foot reflexology will be performed on even days for the intervention group and for the control group, simple foot massage will be performed on odd days. N/A Condition 1: Multiple sclerosis. Condition 2: Restless legs syndrome. Intervention 1: Intervention group: Foot reflexology in the intervention group will be performed for 4 weeks and 3 times per week for 20 minutes (10 minutes for each foot) by a trained researcher in the morning shift and in the afternoon three other days of the week, except for the three days when the researcher performs the intervention in the morning shift, It is done at home by the patient herself. Intervention 2: Control group: The control group will receive a non-specific foot massage without pressing the standard reflexology points with the same conditions and duration as the intervention 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 researcher doesn't have any interest to share because of ethical issues. ( there​ is No further information)
public 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 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) Ability to communicate in Farsi Diagnosis of relapsing-remitting multiple sclerosis (RRMS), according to the patient's medical record Having all four international criteria to diagnose restless legs syndrome Restless leg syndrome severity score based on the questionnaire of the international study group of restless legs syndrome should be 11 or above 11. Having a sleep disorder (a total score of 6 or more based on the Pittsburgh Sleep Quality Index) Healthy and undamaged skin in the lower limbs 18 years 65 years Female Paralysis, amputation, peripheral neuropathy, sensory disorders, vascular disorders, Coagulopathy, deformities or orthopedic problems in the lower limbs. Having neurological diseases other than MS, pregnancy and diseases that cause RLS such as anemia, chronic kidney disease and debilitating and chronic diseases such as cancer, chronic respiratory failure, heart failure, rheumatoid arthritis and lupus erythematosus, according to the patient's medical record Mental illness such as depression according to the patient's self-report Taking medications that worsen restless legs syndrome, such as antidepressants, selective serotonin reuptake inhibitors, antiemetics, anticonvulsants, and dopamine antagonists History of foot reflexology for the treatment of RLS or sleep disorder and use of other complementary and alternative therapies Alcohol and drug addiction G35 G25.8 Multiple sclerosis Other specified extrapyramidal and movement disorders Other Other Intervention group: Foot reflexology in the intervention group will be performed for 4 weeks and 3 times per week for 20 minutes (10 minutes for each foot) by a trained researcher in the morning shift and in the afternoon three other days of the week, except for the three days when the researcher performs the intervention in the morning shift, It is done at home by the patient herself. Control group: The control group will receive a non-specific foot massage without pressing the standard reflexology points with the same conditions and duration as the intervention group. Restless leg syndrome severity. Timepoint: The severity of Restless leg syndrome will be measured before the intervention, immediately after the intervention (at the end of the fourth week) and one month after the intervention. Method of measurement: International Restless Legs Syndrome Study Group Rating Scale. Sleep Quality. Timepoint: Sleep Quality will be measured before the intervention, immediately after the intervention (at the end of the fourth week) and one month after the intervention. Method of measurement: Pittsburgh Sleep Quality Index. Kerman University of Medical Sciences Approved 2023-08-06 Ethics Committee of Kerman University of Medical Sciences Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)