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IRCT20200613047746N1 IRCT 2020-06-18 Kerman University of Medical Sciences Comparison the effect of reflexology and Swedish massage on sleep quality and restless leg syndrome among patients undergoing hemodialysis Comparison the effect of reflexology and Swedish massage on sleep quality and restless leg syndrome among patients undergoing hemodialysis referred to Abu Ali Sina educational and medical center affiliated to Shiraz University of Medical Sciences in 2020 2020-07-22 anticipated 90 Complete https://irct.ir/trial/48899 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The block randomization method will be used to assign samples to three groups (Swedish massage, foot reflexology and control). Blocking will be done using online software (https://www.sealedenvelope.com/simple-randomiser/v1/lists). The size of the blocks will be 6. Using a lottery, each group will be assigned an A, B, and C label, and then samples will be assigned to each group based on a random block list, Blinding description: By assigning a specific number to each of the individuals studied, the person evaluating the consequences of the interventions is blinded by not knowing which person has been subjected to which type of intervention. N/A Hemodialysis patients. Intervention 1: Group 1: Hemodialysis patients under reflexology intervention. Massage at a slow pace with a regular or deep rhythm that would be tolerated by the patient. This protocol will be performed for 20 minutes on both feet (10 minutes for each foot) and in 3 sessions. Group II: Hemodialysis patients under Swedish massage intervention. Massage in this study will be performed once by dialysis for 20 minutes (10 minutes per foot) for 4 weeks (3 times per week) by the researcher. Intervention 2: Control group: In the sham or treatment group (control), by creating the same conditions as the test group, a simple touch of the knee to the sole of the foot without squeezing the standard reflexology points will be performed with the same duration of the test 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 Data not collected.
public Alireza Ghanbari
Molavi Boulevard, 8th Alley
Shiraz Iran (Islamic Republic of) 7145855487 +98 71 3731 3346 Alinurse1371@gmail.com Kerman University of Medical Sciences scientific Parvin Mangolian Shahrbabaki
Faculty of Nursing and Midwifery, Kerman University of Medical Sciences
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5220 mangolian167@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) The age range is 18 to 76 years. At least 3 months have passed since the start of their dialysis. Have hemodialysis at least 3 times a week. Medically, there is no barrier to intervention. 18 years 76 years Both Any medical prohibition to perform the intervention such as diabetic foot wound Lack of cooperation in more than 2 sessions of interventions N18.5 Chronic kidney disease, stage 5 Rehabilitation Rehabilitation Group 1: Hemodialysis patients under reflexology intervention. Massage at a slow pace with a regular or deep rhythm that would be tolerated by the patient. This protocol will be performed for 20 minutes on both feet (10 minutes for each foot) and in 3 sessions. Group II: Hemodialysis patients under Swedish massage intervention. Massage in this study will be performed once by dialysis for 20 minutes (10 minutes per foot) for 4 weeks (3 times per week) by the researcher. Control group: In the sham or treatment group (control), by creating the same conditions as the test group, a simple touch of the knee to the sole of the foot without squeezing the standard reflexology points will be performed with the same duration of the test group. Sleep Quality. Timepoint: 3 times a week for a month. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Restless Legs Syndrome. Timepoint: 3 times a week for a month. Method of measurement: International Restless Legs Syndrome Questionnaire. Kerman University of Medical Sciences Approved 2020-06-02 Ethics Committee of Kerman University of Medical Sciences Beginning of the axis of Haft Bagh Alavi, Campus of Medical Sciences Kerman Kerman Iran (Islamic Republic of)