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IRCT2013091114634N1 IRCT 2013-12-09 Vice chancellor for research, Qazvin University of Medical Sciences Effect of warm footbath on arteriovenous fistula puncture-related pain in hemodialysis patients Effect of warm footbath with and without vibration on arteriovenous fistula puncture-related pain in hemodialysis patients at educational - medical hospitals of Qazvin. 2013-07-23 anticipated 31 Complete https://irct.ir/trial/14213 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive. 2 Arteriovenous fistula puncture-related pain in hemodialysis patients. This research will be an experimental study of the clinical trial with pre-test - post-test method with one group. After learning how to use a pain ruler to Samples, pain assessment will be performed by it. At first pain intensity measurement of all cases will be performed during the six intermittent hemodialysis sessions without intervention then it will be two weeks time interval. In the next step during the six intermittent hemodialysis sessions warm footbath with vibration done and the pain will be assessed after the intervention then it will be two weeks time interval again. In the final step during the six intermittent hemodialysis sessions warm footbath without vibration done and the pain will be assessed after the intervention. In both methods of intervention samples in the supine position with bending the knees will submerge their legs into the warm water. Legs will be submerged above the ankle in the 40 ± 2 ° C water for ten minutes. Embedding fistula needles will be ten minutes after the start of the intervention and immediately after that, the patient will be asked to determine the number of pain intensity on pain ruler. After the intervention, the patient's feet will be dry with a disposable towel. In the first method warm footbath with vibration will be done by using footbath massager machine made in Germany. The device is adjustable and constant water temperature of 40 ± 2 ° C is the same as it is able to induce vibrations in the water. It should be noted that the device is not for personal use and it is washable and disinfection after each use, which will be done after each intervention. In the second method warm footbath without vibration will be done by using a plastic pan and pouring the 40 ± 2 ° C water inside it. Initially as a pilot the 40 ± 2 ° C water will be poured into plastic pan and its temperature will be measured continuously for ten minutes until the water temperature drops be determined then by removing amounts of water from the pan and adding the same amount of warm water, amount of water that must be added and removed during the study and the time required will be determined as the temperature of the water in the plastic pan is kept constant at 40 ± 2 ° C. For all samples, the same size and shape of the plastic pans will be used. Plastic pan also will be washed and disinfected after each intervention. Water temperature will be measured by a standard mercury thermometer..
public Zahra Abbas Ali Madadi
Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin
Qazvin Iran (Islamic Republic of) 3419759811 +98 28 1333 8127 Zabbasalimadadi@qums.ac.ir Qazvin University of Medical Sciences scientific Jalil Azzimian
Faculty of Nursing and Midwifery, Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin
Qazvin Iran (Islamic Republic of) 3419759811 +98 28 1333 8127 azzimianj@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Major inclusion criteria: having an arteriovenous fistula; absence of evidence of peripheral vascular disease; no wounds to both legs above the ankle area; there is no impairment of consciousness and knowledge of the time and place and person; the ability to communicate verbally and audio; having age between 17-65 years; the last three months of fistula placement; no history of diabetes; no history of sensory and neurological disorders; Lack of consistent use of the substance, drug or relieve method to be effective on pain of fistula Needles. Major exclusion criteria: No need to go on hemodialysis; patients travel long; kidney transplantation; lack of consent to continue to participate in the study; the patient dies; if the patient is reported any other pain at evaluation or intervention time and or used of the substance, drug or relieve method which be effective on pain of Fistula Needles, excluded from the dialysis session and the next session will be enrolled in the study again but if this process is repeated in several sessions the patient will be completely excluded. 17 years 65 years Both T82.4 Mechanical complication of vascular dialysis catheter Other This research will be an experimental study of the clinical trial with pre-test - post-test method with one group. After learning how to use a pain ruler to Samples, pain assessment will be performed by it. At first pain intensity measurement of all cases will be performed during the six intermittent hemodialysis sessions without intervention then it will be two weeks time interval. In the next step during the six intermittent hemodialysis sessions warm footbath with vibration done and the pain will be assessed after the intervention then it will be two weeks time interval again. In the final step during the six intermittent hemodialysis sessions warm footbath without vibration done and the pain will be assessed after the intervention. In both methods of intervention samples in the supine position with bending the knees will submerge their legs into the warm water. Legs will be submerged above the ankle in the 40 ± 2 ° C water for ten minutes. Embedding fistula needles will be ten minutes after the start of the intervention and immediately after that, the patient will be asked to determine the number of pain intensity on pain ruler. After the intervention, the patient's feet will be dry with a disposable towel. In the first method warm footbath with vibration will be done by using footbath massager machine made in Germany. The device is adjustable and constant water temperature of 40 ± 2 ° C is the same as it is able to induce vibrations in the water. It should be noted that the device is not for personal use and it is washable and disinfection after each use, which will be done after each intervention. In the second method warm footbath without vibration will be done by using a plastic pan and pouring the 40 ± 2 ° C water inside it. Initially as a pilot the 40 ± 2 ° C water will be poured into plastic pan and its temperature will be measured continuously for ten minutes until the water temperature drops be determined then by removing amounts of water from the pan and adding the same amount of warm water, amount of water that must be added and removed during the study and the time required will be determined as the temperature of the water in the plastic pan is kept constant at 40 ± 2 ° C. For all samples, the same size and shape of the plastic pans will be used. Plastic pan also will be washed and disinfected after each intervention. Water temperature will be measured by a standard mercury thermometer. Pain intensity. Timepoint: In every hemodialysis session. Method of measurement: By using a numerical pain intensity scale (pain ruler). Footbath with vibration method. Timepoint: Six intermittent hemodialysis sessions. Method of measurement: Method mentions in the information form. Footbath without vibration method. Timepoint: Six intermittent hemodialysis sessions. Method of measurement: Method mentions in the information form. Age. Timepoint: First meeting of evaluation. Method of measurement: Based on year in the information form. Sex. Timepoint: First meeting of evaluation. Method of measurement: Based on sex in the information form. Hemodialysis times a week. Timepoint: First meeting of evaluation. Method of measurement: Times number mentions in the information form. The duration of arteriovenous fistula. Timepoint: First meeting of evaluation. Method of measurement: Based on year and month in the information form. Arteriovenous fistula site. Timepoint: First meeting of evaluation. Method of measurement: Site mentions in the information form. History of previous AVF. Timepoint: First meeting of evaluation. Method of measurement: Yes or no mentions in the information form. Vice chancellor for research, Qazvin University of Medical Sciences Approved 2013-07-10 Ethics Committee of Qazvin University of Medical Sciences Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin Qazvin Iran (Islamic Republic of)