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IRCT20100211003329N8 IRCT 2022-02-24 Kashan University of Medical Sciences The effect of black seed oil massage on the severity of restless legs syndrome in patients with type 2 diabetes The effect of black seed oil massage on the severity of restless legs syndrome in patients with type 2 diabetes 2022-03-06 anticipated 76 Complete https://irct.ir/trial/61850 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: How to select the samples will be randomly assigned to each of the two intervention and comparison groups in block, 4, 6 and 8 blocks. Using Sealed Envelope Ltd. software. 2017 Through the site www.sealedenvelope.com 3 blocks of 4, 6 blocks of 6 and 4 blocks of 8, a total of 13 blocks (In the form of a number) were defined, which will be assigned to groups according to the order specified by the tool, Blinding description: Outcome assessors and analyzer are unaware of the effect of black seed oil massage on Restless Legs Syndrome in type 2 diabetic patients. 2-3 Condition 1: Restless legs Syndrom. Condition 2: Diabetes Type 2. Intervention 1: Intervention group: The subject and objectives of the study are explained for each of participants, and if she/he wish to participate in the study, a questionnaire for diagnosing Restless Legs Syndrome and a checklist of demographic information for patients will be completed. It should be noted that skin sensitivity of individuals to study is also examined. For this purpose, 5 cc of black seed oil is massaged on the person's skin with the desired purity, and in case of any symptoms of erythema, inflammation, blisters and other symptoms of skin allergies, while eliminating the person's symptoms, it will be removed from the study. Eligible individuals (earning a score of 11 or higher according to the IRLSS checklist) after being selected and obtaining consent to participate in the study, are introduced, reviewed, and randomly entered to study.In the intervention group for 40 nights, one night in between, before going to bed, black seed oil prepared from Barij Essential Oil Company with a purity of 5%, in the amount of 2 cc is used for each foot (a total of 80 cc for each participant should be considered). Will give, and for heterosexual participants, the male colleague will be helped to train the male participants and do it once.The method of massage is such that each person Applying black palm oil (2 cc) on the palms of the hands, continuously massaging the fingers from the toes, then the soles of the feet and gradually continuing to the top of the knees. At the end of the intervention, restlessness questionnaires were completed for patients in both groups. Intervention 2: Control group: In the control group, only routine treatments (Take drugs such as pramipexole and cabergoline, gabapentin, benzodiazepines, ibuprofen and codeine) will be performed. No - There is not a plan to make this available Justification or reason for not sharing IPD is Not done yet
public Mansour Dianati
Kashan University of Medical Sciences, Pezeshk Blvd, Ghotb Ravandi Blvd, Kashan
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5558 9021 mandianati@gmail.com Kashan University of Medical Sciences scientific Mansour Dianati
Kashan University of Medical Sciences, Pezeshk Blvd, Ghotb Ravandi Blvd, Kashan
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5558 9021 mandianati@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in research and conscious satisfaction Having type 2 diabetes Lack of sensitivity to black seed oil Do not take sleeping pills and psychiatric drugs no limit no limit Both diabetic foot ulcers heart, lung or brain disease G25.81 E11 Restless legs syndrome Type 2 diabetes mellitus Treatment - Drugs Treatment - Drugs Intervention group: The subject and objectives of the study are explained for each of participants, and if she/he wish to participate in the study, a questionnaire for diagnosing Restless Legs Syndrome and a checklist of demographic information for patients will be completed. It should be noted that skin sensitivity of individuals to study is also examined. For this purpose, 5 cc of black seed oil is massaged on the person's skin with the desired purity, and in case of any symptoms of erythema, inflammation, blisters and other symptoms of skin allergies, while eliminating the person's symptoms, it will be removed from the study. Eligible individuals (earning a score of 11 or higher according to the IRLSS checklist) after being selected and obtaining consent to participate in the study, are introduced, reviewed, and randomly entered to study.In the intervention group for 40 nights, one night in between, before going to bed, black seed oil prepared from Barij Essential Oil Company with a purity of 5%, in the amount of 2 cc is used for each foot (a total of 80 cc for each participant should be considered). Will give, and for heterosexual participants, the male colleague will be helped to train the male participants and do it once.The method of massage is such that each person Applying black palm oil (2 cc) on the palms of the hands, continuously massaging the fingers from the toes, then the soles of the feet and gradually continuing to the top of the knees. At the end of the intervention, restlessness questionnaires were completed for patients in both groups. Control group: In the control group, only routine treatments (Take drugs such as pramipexole and cabergoline, gabapentin, benzodiazepines, ibuprofen and codeine) will be performed Severity of restlessness leg syndrome. Timepoint: Before the intervention, after the intervention. Method of measurement: Using the standard Restless Legs Syndrome checklist. Kashan University of Medical Sciences Approved 2022-02-07 Ethics Committee of Kashan University of Medical Sciences Kashan. Qutb Ravandi Blvd., Pezeshk Blvd., Kashan University of Medical Sciences Kashan Isfehan Iran (Islamic Republic of)