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IRCT20210523051370N7 IRCT 2022-07-05 Mazandaran University of Medical Sciences Effect of foot massage with lavender essential oil in comparison to paraffin oil on restless legs syndrome (RLS) and anxiety levels Effect of foot massage with lavender essential oil 1.5% in comparison to paraffin oil on the severity of restless legs syndrome and anxiety levels in hemodialysis patients 2022-07-02 anticipated 68 Complete https://irct.ir/trial/63886 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: The experimental group will receive foot massage with lavender essential oil and oral paraffin oil 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 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, Randomization description: Patients will be recruited using convenience sampling method and then will be assigned to the experimental group (EG) and control group (CG) 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 lavender essential oil on the assessor's and masseur face mask can suppress the sharpness of the smell of aroma oil. Patients will also be wearing a face mask during the intervention. N/A Restless legs syndrome; anxiety levels. Intervention 1: The experimental group will receive foot massage with lavender 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. 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is To keep patient data confidential
public Dr Seyed Afshin Shorofi
Mazandaran University of Medical Sciences
Sari Iran (Islamic Republic of) 4816715793 +98 911 676 6280 ashorofi@yahoo.com Mazandaran University of Medical Sciences scientific Dr Seyed Afshin Shrofi
Mazandaran University of Medical Sciences
Sari Iran (Islamic Republic of) ۴۸۱۶۷۱۵۷۹۳ 098 11 33367342 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 (HD), three times a week for the last 6 months Ability to walk on affected legs independently Having symptoms of restless legs syndrome 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 Withdrawal criteria: Patient's death; Transfer to other hemodialysis centers; Emergency hemodialysis; Any side effects related to the intervention; Missing two hemodialysis sessions; Any interaction between the intervention and patients' medical and nursing care; Unwillingness to continue participation; Eligibility criteria violation. G25.81 Restless legs syndrome Prevention Prevention The experimental group will receive foot massage with lavender 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. 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. Anxiety levels. Timepoint: Baseline (before intervention: T0); Follow-ups (after 6th session: T1; a week after the 6th session: T2). Method of measurement: HADS-anxiety. Mazandaran University of Medical Sciences Approved 2022-06-01 Bioethics Committee of Mazandaran University of Medical Sciences Deputy of Research and Technology, Moalem Square, Sari, Mazandaran Province Sari Mazandaran Iran (Islamic Republic of)