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IRCT20220512054826N1 IRCT 2022-05-23 Gonabad University of Medical Sciences Comparison the effect of EMLA Cream and lidocaine spray with rhythmic breathing on pain intensity due to arterial-venous needles in hemodialysis patients Comparison the effect of EMLA Cream and lidocaine spray with rhythmic breathing on pain intensity due to arterial-venous needles in hemodialysis patients 2022-06-22 anticipated 88 Complete https://irct.ir/trial/63513 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling will be done first from all patients in the center who meet the inclusion criteria by the available sampling method. They will then be randomly assigned to one of two groups of EMLA cream and lidocaine spray with rhythmic breathing using quadruple permutation blocks. Random allocation of research units was performed using quadruple permutation blocks. For this purpose, the intervention group with EMLA cream, A and the intervention group with lidocaine spray with rhythmic breathing, B will be considered. The quadruple blocks include the six blocks AABB, ABAB, ABBA, BABA, BBAA and BAAB. Each block will be given a code from 1 to 6. Due to the fact that the total sample size of this study was 88 people, the selection of blocks will be done 22 times by throwing the dice and based on the obtained list, patients will be divided into two study groups, Blinding description: In this study, the outcome evaluator who measures the severity of pain when a dialysis needle enters a fistula is unaware of the type of intervention. 2 Severe pain of needle insertion into venous arterial fistula in hemodialysis patients. Intervention 1: Intervention group: In the EMLA Cream group, in the first session, patients are given the necessary explanations related to the research, and at the end of the first hemodialysis session, for the next session, the EMLA Cream is provided to patients with a transparent dressing. Patients are instructed to apply 2 grams of the drug at home at the fistula site at an approximate level of 5cm2 on the fistula surface at home 60 minutes before the visit, and to cover the area with a transparent dressing. In the second session, before canulation, the dressing is removed and after disinfecting the area with a cotton swab dipped in 70% alcohol, to prevent venous contraction caused by EMLA Cream, after 10 minutes, hemodialysis needles are inserted into the arteries of the fistula area. Intervention 2: Intervention group: In the lidocaine spray group with rhythmic breathing, for rhythmic breathing, rhythmic breathing is taught as follows. Two minutes before inserting the vascular needles, perform rhythmic breathing in such a way that the patient closes his eyes, lies on his back (supine) and performs tail inhalation through the nose by counting numbers from 1 to 3 Then, by re-counting the numbers 1 to 3, he holds his breath and by counting the numbers 1 to 3, he exhales through his mouth. All patients in the intervention group are instructed to focus only on the entry and exit of air during respiration. Patients, focusing their minds on this method of breathing, repeat it two minutes before the needle is inserted and during the time the needle is inserted. And in the same group lidocaine spray; After cleaning the skin of the area, two puffs of lidocaine spray (20 mg) are sprayed by the researcher from a distance of 5 cm on the skin surface where the needle enters. Due to the fact that local anesthesia develops 1-5 minutes after the use of lidocaine spray depending on the desired location, 5 minutes after the use of lidocaine spray while the skin of the arterial needle is after disinfecting the area with a cotton swab dipped in 70% alcohol. Needle By a hemodialysis nurse is inserted into the arteries of the fistula area. 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 There is no more information
public Mohammad Gholizadeh
Asian Roadside, Gonabad University of Medical Sciences, School of Nursing
Gonabad Iran (Islamic Republic of) 9691699967 +98 51 5722 3513 Mohammadgholizadeh762700@gmail.com Gonabad University of Medical Sciences scientific دکتر علی محمد پور
Asian Roadside, Gonabad University of Medical Sciences, School of Nursing
Gonabad Iran (Islamic Republic of) 9691699967 +98 51 5722 3513 amohammadpur@yahoo.com Gonabad University of Medical Sciences Iran (Islamic Republic of) A history of at least 3 months of hemodialysis through fistula Age over 18 years Alert lack of difficulty in accessing arteries lack of neuropathic disorders and peripheral vascular diseases Not receiving painkillers or sedatives at least 6 hours before hemodialysis lack of severe pain in other areas Minimum literacy lack of Recognized mental disability lack of addiction or dependence on painkillers Lack of treat with sulfonamides, nitrates and phenobarbital lack of history of Fauvism 18 years no limit Both The patient's unwillingness to continue collaborating in the research Unsuccessful cannulation in the first attempt and repeated insertion of the needle into the skin Creating a critical life-threatening situation T82.848A Pain from vascular prosthetic devices, implants and grafts, initial encounter Prevention Prevention Intervention group: In the EMLA Cream group, in the first session, patients are given the necessary explanations related to the research, and at the end of the first hemodialysis session, for the next session, the EMLA Cream is provided to patients with a transparent dressing. Patients are instructed to apply 2 grams of the drug at home at the fistula site at an approximate level of 5cm2 on the fistula surface at home 60 minutes before the visit, and to cover the area with a transparent dressing. In the second session, before canulation, the dressing is removed and after disinfecting the area with a cotton swab dipped in 70% alcohol, to prevent venous contraction caused by EMLA Cream, after 10 minutes, hemodialysis needles are inserted into the arteries of the fistula area. Intervention group: In the lidocaine spray group with rhythmic breathing, for rhythmic breathing, rhythmic breathing is taught as follows. Two minutes before inserting the vascular needles, perform rhythmic breathing in such a way that the patient closes his eyes, lies on his back (supine) and performs tail inhalation through the nose by counting numbers from 1 to 3 Then, by re-counting the numbers 1 to 3, he holds his breath and by counting the numbers 1 to 3, he exhales through his mouth. All patients in the intervention group are instructed to focus only on the entry and exit of air during respiration. Patients, focusing their minds on this method of breathing, repeat it two minutes before the needle is inserted and during the time the needle is inserted. And in the same group lidocaine spray; After cleaning the skin of the area, two puffs of lidocaine spray (20 mg) are sprayed by the researcher from a distance of 5 cm on the skin surface where the needle enters. Due to the fact that local anesthesia develops 1-5 minutes after the use of lidocaine spray depending on the desired location, 5 minutes after the use of lidocaine spray while the skin of the arterial needle is after disinfecting the area with a cotton swab dipped in 70% alcohol. Needle By a hemodialysis nurse is inserted into the arteries of the fistula area. Pain. Timepoint: Before and after the intervention. Method of measurement: Visual Analog Scale. Gonabad University of Medical Sciences Approved 2022-04-11 Ethics committee of Gonabad University of Medical Sciences Khorasan Razavi - Gonabad, Asian Roadside, Vice Chancellor for Research and Technology Gonabad University of Medical Sciences Gonabad Razavi Khorasan Iran (Islamic Republic of)