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IRCT20230611058450N1 IRCT 2023-09-18 Bandare-abbas University of Medical Sciences Investigating the effect of exfoliation massage and diluted vinegar solution on sleep quality Comparing the effects of efflorescence massage and diluted vinegar solution on sleep quality in hemodialysis patients 2023-07-23 anticipated 80 Complete https://irct.ir/trial/70827 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The statistical population of this research consists of all patients referred to the hemodialysis department (170 people). The names of all patients are registered in the hemodialysis appointment schedule (hours/days/weeks/months) and can be accessed. All patients are coded (01 to 170), then using the random numbers table and moving in the first column from right to left and from top to bottom according to the determined sample size (up to 80 people), the research sample will be selected. If the selected patient does not want to participate in the study, the sample selection process will continue from the end point of the sample selection in the table until the completion of the research sample. Necessary information is provided to selected patients. After obtaining consent and agreement to participate in the study, random allocation of samples will be done using the envelope lottery method in the intervention group (40 people) and the control group (40 people), Blinding description: For the purpose of blinding, each patient and each group is assigned a code, and the evaluator uses the code assigned to the patients (without knowing whether the patient is in the intervention or control group) when the patients come for the fourth appointment (the number of times of routine hemodialysis It is recorded in the patients' files in the hemodialysis department) considering the general condition of the patients before hemodialysis or during the first hour of hemodialysis, the evaluator completes the research tools, scales and data collection, then leaves the department and There will be no further contact with patients. The fourth hemodialysis of the patients is also done within 3 to 4 hours (routine of the department). At the end, the patients are separated from the machine and receive the standard and common care of the department. Control group patients leave the ward. Patients in the intervention group are directed to a special room to receive exfoliation massage and vinegar solution (about 15 minutes) and then leave the ward. This process will be repeated after every three hemodialysis sessions until the end of the 12th hemodialysis session. It is necessary to explain that patients have 2 or 3 appointments per week at specific hours, depending on their physical conditions and so-called tolerance. The statistical analyst will also perform analyzes using the registered codes of the groups (without knowing whether the patient is in the intervention or control group). N/A Dependence on renal dialysis. Intervention 1: Intervention group: In addition to the routine and standard care of the intervention group, at the end of each hemodialysis session, the samples of the intervention group will receive exfoliation massage plus 0.3% diluted vinegar solution. The massage will be done on the back and legs (common areas of itching), which includes three back massages (full back massage, horizontal full back massage, sliding thumbs on the spine muscles) each step 15 times and a total of about 6 minutes and massage The front of the leg (legs and thighs) for 4 minutes, that is, two minutes for each leg, and the back of the leg (the back of the leg and thighs) for 4 minutes, that is, two minutes for each leg (20 repetitions for each) on the patient and in total It takes 14 minutes. During the massage, lubricant gel will be used as a media for a better massage effect and slippery position. The amount of gel used will be 30-60 cc according to the needs and according to the size of the people. In this study, 5% industrial white vinegar solution is used in the amount of 30 cc, which will reach 500 cc by adding the purified water of the dialysis section. This solution will be carefully prepared by the researcher using special measuring containers. 5% industrial white vinegar, a product of Asiashore Company, which after dilution reaches a concentration of 0.3%, then using a sponge (10 x 20 cm) soaked in diluted vinegar solution is massaged on the skin and on the areas. In the direction of the massage movement, it will be stretched twice in each area, once to maintain the pH of the skin and to ensure the removal of skin waste products. Two containers are used, one for washing the sponge and the other for soaking the sponge in vinegar solution. Intervention 2: Control group: Examples of the routine and standard care control group of the department, which include: training provided by personnel in the form of pamphlets or face-to-face and feedback-based, training provided by the resident doctor of the hemodialysis center, compliance with diets (low protein, low phosphorus diet), Skin care of the itchy areas for less irritation and using the right detergent, not scratching the skin, keeping it clean and maintaining skin hygiene. In this group, the drugs prescribed by the doctor are not stopped during the intervention. These drugs include antihistamines, gabapentin, and Renagel. The samples in both groups are subjected to a skin test with a diluted vinegar solution before starting the intervention to ensure the absence of sensitivity. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions will be available Conditions: Meta analysis Where to obtain: Hadi Yousefi by email How to obtain: Submit a request by email and receive a response within a week Comments: at your service
public Hadi Yousefi
Imam Hossein Blvd., University of Medical Sciences Campus Educational Complex, Faculty of Medicine, Department of Social Medicine
Bandar Abbas Iran (Islamic Republic of) 7919693116 +98 76 3371 0370 hadiyousefi1@hums.ac.ir Bandare-abbas University of Medical Sciences scientific Hadi Yousefi
Imam Hossein Blvd., University of Medical Sciences Campus Educational Complex, Faculty of Medicine, Department of Social Medicine
Bandar Abbas Iran (Islamic Republic of) 7919693116 +98 76 3371 0370 hadiyousefi1@hums.ac.ir Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients should voluntarily participate in the research Patients who are treated with hemodialysis for more than three months Patients who undergo hemodialysis treatment three times a week Patients who have an itch score above 3 Patients should be over 18 years old 18 years no limit Both Have any wound, pain and skin discomfort or any other skin problem other than uremic itching Phosphorus serum level should be more than 6 mg/dl and parathormone serum level should be more than 600 pg/ml. have skin sensitivity to vinegar solution or are candidates for kidney transplant Suffering from mental and cognitive disorders or banning massage due to embolism, DVT, fracture, dislocation, physical damage to the limbs and spine. The occurrence of an unfortunate and stressful accident in the last 2 months or the use of drugs Patients who are hemodialyzed with a solution other than bicarbonate and non-Polysulfone filters Z99.2 Dependence on renal dialysis Rehabilitation Rehabilitation Intervention group: In addition to the routine and standard care of the intervention group, at the end of each hemodialysis session, the samples of the intervention group will receive exfoliation massage plus 0.3% diluted vinegar solution. The massage will be done on the back and legs (common areas of itching), which includes three back massages (full back massage, horizontal full back massage, sliding thumbs on the spine muscles) each step 15 times and a total of about 6 minutes and massage The front of the leg (legs and thighs) for 4 minutes, that is, two minutes for each leg, and the back of the leg (the back of the leg and thighs) for 4 minutes, that is, two minutes for each leg (20 repetitions for each) on the patient and in total It takes 14 minutes. During the massage, lubricant gel will be used as a media for a better massage effect and slippery position. The amount of gel used will be 30-60 cc according to the needs and according to the size of the people. In this study, 5% industrial white vinegar solution is used in the amount of 30 cc, which will reach 500 cc by adding the purified water of the dialysis section. This solution will be carefully prepared by the researcher using special measuring containers. 5% industrial white vinegar, a product of Asiashore Company, which after dilution reaches a concentration of 0.3%, then using a sponge (10 x 20 cm) soaked in diluted vinegar solution is massaged on the skin and on the areas. In the direction of the massage movement, it will be stretched twice in each area, once to maintain the pH of the skin and to ensure the removal of skin waste products. Two containers are used, one for washing the sponge and the other for soaking the sponge in vinegar solution. Control group: Examples of the routine and standard care control group of the department, which include: training provided by personnel in the form of pamphlets or face-to-face and feedback-based, training provided by the resident doctor of the hemodialysis center, compliance with diets (low protein, low phosphorus diet), Skin care of the itchy areas for less irritation and using the right detergent, not scratching the skin, keeping it clean and maintaining skin hygiene. In this group, the drugs prescribed by the doctor are not stopped during the intervention. These drugs include antihistamines, gabapentin, and Renagel. The samples in both groups are subjected to a skin test with a diluted vinegar solution before starting the intervention to ensure the absence of sensitivity. Sleep onset disorder. Timepoint: Before the intervention, the end of the third session of hemodialysis, the end of the sixth session of hemodialysis, the end of the ninth session of hemodialysis, the end of the twelfth session of hemodialysis. Method of measurement: Sleep disorder questionnaire by Mohammadi et al. (2008). Disruption of sleep continuity. Timepoint: Before the intervention, the end of the third session of hemodialysis, the end of the sixth session of hemodialysis, the end of the ninth session of hemodialysis, the end of the twelfth session of hemodialysis. Method of measurement: Sleep disorder questionnaire by Mohammadi et al. (2008). Trouble waking up. Timepoint: Before the intervention, the end of the third session of hemodialysis, the end of the sixth session of hemodialysis, the end of the ninth session of hemodialysis, the end of the twelfth session of hemodialysis. Method of measurement: Sleep disorder questionnaire by Mohammadi et al. (2008). Total score of sleep disturbance. Timepoint: Before the intervention, the end of the third session of hemodialysis, the end of the sixth session of hemodialysis, the end of the ninth session of hemodialysis, the end of the twelfth session of hemodialysis. Method of measurement: Sleep disorder questionnaire by Mohammadi et al. (2008). Bandare-abbas University of Medical Sciences Approved 2023-05-10 Ethics committee of Hormozgan University of Medical Sciences Chamran Blvd., Hormozgan University of Medical Sciences and Health Services. Bandar Abbas, Iran. Bandar Abbas Hormozgan Iran (Islamic Republic of)