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IRCT20210523051370N1 IRCT 2021-07-06 Mazandaran University of Medical Sciences The effect of foot massage with olive oil on restless legs syndrome The effect of foot massage with olive oil on the severity of restless legs syndrome in hemodialysis patients 2021-07-22 anticipated 68 Complete https://irct.ir/trial/56828 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: The experimental group will receive foot massage with virgin olive oil (Loyeh, Iran) and oral paraffin oil (Fadak, Iran) will be used for the foot message of the control group. A ten-minute massage (five minutes per foot) from below the knee to the soles of both feet will be performed six times in two weeks (three times a week). The patients will receive massage one hour after the onset of dialysis. The massage starts from the plantar surface of the sole of the foot towards the heel and the dorsal surface of the foot towards the ankle, and then the posterior and anterior parts of the leg up to the knee are massaged. The same technique will be used immediately for the other leg. In the control group, each foot will be massaged using 10 cc of paraffin oil, as in the experimental group, in terms of method and duration. The effleurage technique will be used in the massage therapy protocol, Randomization description: Patients will be recruited using convenience sampling method and then will be assigned to the experimental and control groups using permuted block randomisation (17 blocks - block size of 4). The blocks will be numbered and sealed in 17 sequentially numbered opaque envelopes in random order. The envelopes will be opened individually and the patients will be assigned to the relevant groups. The Random Allocation Software 2.0 will be used to generate randomisation sequences, Blinding description: The patients, assessor and masseur will be blinded to the random allocation. A few drops of olive oil on the assessor's and masseur face mask can suppress the sharpness of the smell of olive oil. Patients will also be wearing a face mask during the intervention. N/A Restless legs syndrome. Intervention 1: The experimental group will receive foot massage with virgin olive oil (Loyeh, Iran). A ten-minute massage (five minutes per foot) from below the knee to the soles of both feet will be performed six times in two weeks (three times a week). The patients will receive massage one hour after the onset of dialysis. The massage starts from the plantar surface of the sole of the foot towards the heel and the dorsal surface of the foot towards the ankle, and then the posterior and anterior parts of the leg up to the knee are massaged. The same technique will be used immediately for the other leg. The effleurage technique will be used in the massage therapy protocol. Intervention 2: The control group will receive foot massage with oral paraffin oil. A ten-minute massage (five minutes per foot) from below the knee to the soles of both feet will be performed six times in two weeks (three times a week). The patients will receive massage one hour after the onset of dialysis. The massage starts from the plantar surface of the sole of the foot towards the heel and the dorsal surface of the foot towards the ankle, and then the posterior and anterior parts of the leg up to the knee are massaged. The same technique will be used immediately for the other leg. In the control group, each foot will be massaged using 10cc of paraffin oil, as in the experimental group, in terms of method and duration. The effleurage technique will be used in the massage therapy protocol. 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 All data will be kept confidential.
public Dr Seyed Afshin Shorofi
Mazandaran University of Medical Sciences, Sari
Sari Iran (Islamic Republic of) 4815733971 +98 11 3336 7342 ashorofi@yahoo.com Mazandaran University of Medical Sciences scientific Dr Seyed Afshin Shorofi
Mazandaran University of Medical Sciences, Sari
Sari Iran (Islamic Republic of) 4815733971 +98 11 3336 7342 ashorofi@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Aged 18-65 years; Willingness to participate in the study; Being conscious (oriented to place, person and time); Continuous treatment with hemodialysis, three times a week for the last 6 months; Ability to walk on affected legs independently; Symptoms of restless legs syndrome (RLS) at least twice a week 18 years 65 years Both Allergic to herbal plants (including essential oils and herbal extracts); Any nervous system, vascular, skeletal and muscular disorders/abnormalities in the lower limbs; Simultaneous participation in other research studies investigating the relief of restless legs syndrome; History of drug and alcohol abuse; Any mental illness, dementia, and intellectual impairment; History of deep vein thrombosis; Pregnancy and breastfeeding; Use of psychiatric and neurological medications; Use of other herbal products to relieve restless legs syndrome. G25.81 Restless legs syndrome Other Other The experimental group will receive foot massage with virgin olive oil (Loyeh, Iran). A ten-minute massage (five minutes per foot) from below the knee to the soles of both feet will be performed six times in two weeks (three times a week). The patients will receive massage one hour after the onset of dialysis. The massage starts from the plantar surface of the sole of the foot towards the heel and the dorsal surface of the foot towards the ankle, and then the posterior and anterior parts of the leg up to the knee are massaged. The same technique will be used immediately for the other leg. The effleurage technique will be used in the massage therapy protocol. The control group will receive foot massage with oral paraffin oil. A ten-minute massage (five minutes per foot) from below the knee to the soles of both feet will be performed six times in two weeks (three times a week). The patients will receive massage one hour after the onset of dialysis. The massage starts from the plantar surface of the sole of the foot towards the heel and the dorsal surface of the foot towards the ankle, and then the posterior and anterior parts of the leg up to the knee are massaged. The same technique will be used immediately for the other leg. In the control group, each foot will be massaged using 10cc of paraffin oil, as in the experimental group, in terms of method and duration. The effleurage technique will be used in the massage therapy protocol. Severity of Restless Legs Syndrome. Timepoint: Baseline (before intervention: T0); Follow-ups (after 6th session: T1; a week after the 6th session: T2). Method of measurement: International Restless Legs Severity Scale. Mazandaran University of Medical Sciences Approved 2021-06-08 Bioethics Committee of Mazandaran University of Medical Sciences Deputy of Research and Technology, Moalem Square Sari Mazandaran Iran (Islamic Republic of)