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IRCT20210626051716N1 IRCT 2021-07-29 Gonabad University of Medical Sciences Comparison of the Effect of Rhythmic Respiration and Lidocaine Spray on the Severity of Arteriovenous Fistula Venipuncture Pain in Patients undergoing hemodialysis Comparison of the Effect of Rhythmic Respiration and Lidocaine Spray on the Severity of Arteriovenous Fistula Venipuncture Pain in Patients undergoing hemodialysis 2021-07-30 anticipated 54 Complete https://irct.ir/trial/57164 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 rhythmic respiration and lidocaine spray using quadruple permutation blocks.Random allocation of research units was performed using quadruple permutation blocks.For this purpose, the intervention group with rhythmic breathing will be considered A and the intervention group with lidocaine spray will be considered B.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.Given that the total sample size of this study was 54 people, blocks will be selected 14 times using dice and According to the list, patients will be divided into two study groups, Blinding description: In this study, the outcome assessor who measures the severity of pain when a dialysis needle enters a fistula is unaware of the type of intervention. N/A Severity of Arteriovenous Fistula Venipuncture Pain in Patients undergoing Hemodialysis. Intervention 1: Intervention group:The patient is asked during the Hemodialysis session, perform rhythmic breathing two minutes before inserting the vascular needles as follows. Lie down in a comfortable position, close your eyes and do a deep, long breath through the nose with three numbers. Then hold your breath in the lungs and count to three, then exhale slowly through the mouth with three numbers one. By focusing their minds on this method of breathing, patients repeat it over time as Hemodialysis needles are inserted into the arteries of the fistula.This intervention will be repeated three times in a row Hemodialysis on patients in this group. Intervention 2: Intervention group: In the Lidocaine spray group, lie down in a comfortable position for two minutes before inserting the patient's vascular needles، after cleaning the skin of the needle entry area, two puffs of 10% Lidocaine spray (20 mg) will be sprayed from a distance of 5 cm on the skin surface where the needle enters. 5 minutes after using Lidocaine spray while disinfecting the skin at the site of arterial needle entry with 70% alcohol، the Hemodialysis needle is inserted into the arteries of the fistula area by the ward nurse.This intervention will be repeated three times in a row Hemodialysis on patients in this group. Yes - There is a plan to make this available What will be shared: Individual demographic information and mean pain score evaluated after each intervention and its comparative results will be shared. When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions or people who are also engaged in industry Conditions: Submission of documents will be allowed if the purpose of the request is to upgrade and complete or conduct studies in similar fields. Where to obtain: 1- Phone number: 09394059487 2- Email: SadeghpourMH3@mums.ac.ir 3- Address: Mashhad, 34 Fakuri Blvd., Nikan Farda Hemodialysis Center, Mr. Ali Dorost How to obtain: First, call 09394059487, which, after coordination, will be provided via email or in person. Comments:
public Tahere Baloochi
School of Nursing, Gonabad University of Medical Sciences, Asian Roadside, Khorasan Razavi - Gonabad
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 3028 tbaloochi@gmail.com Gonabad University of Medical Sciences scientific Tahere Baloochi
School of Nursing, Gonabad University of Medical Sciences, Asian Roadside, Khorasan Razavi – Gonabad
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 3028 tbaloochi@gmail.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Be between 18 and 60 years old Willing to cooperate and participate in research At least 3 months have passed since the fistula was implanted Lack of pacemaker Having an active record so that three sessions per week and each session for 4 hours to be treated with Hemodialysis Absence of skin problems, lack of anesthesia, neuropathic disorders and peripheral vascular diseases at the fistula site If you have diabetes, have controlled diabetes (FBS samples in the range of 70 to 150 and BS in the range of 120 to 250) Do not have verbal, visual or auditory impairment Lack of known allergy to Lidocaine Do not have drug addiction and dependence on painkillers Have not received painkillers or sedatives 6 hours before Hemodialysis Do not have pain in other parts of the body 18 years 60 years Both Do not want to continue collaborating in research Lack of patient awareness at any stage of the research Failure of the needle to enter the arteries of the fistula area in the first attempt and the need to repeat the Cannulation Incidence of Lidocaine sensitivity at any stage of the study Onset of other chronic pain that affects the assessment of pain due to needle insertion into the fistula Failure to refer to the research stages (refer to other medical centers to continue treatment, travel, kidney transplant, death) T82.848A Pain from vascular prosthetic devices, implants and grafts, initial encounter Prevention Prevention Intervention group:The patient is asked during the Hemodialysis session, perform rhythmic breathing two minutes before inserting the vascular needles as follows. Lie down in a comfortable position, close your eyes and do a deep, long breath through the nose with three numbers. Then hold your breath in the lungs and count to three, then exhale slowly through the mouth with three numbers one. By focusing their minds on this method of breathing, patients repeat it over time as Hemodialysis needles are inserted into the arteries of the fistula.This intervention will be repeated three times in a row Hemodialysis on patients in this group. Intervention group: In the Lidocaine spray group, lie down in a comfortable position for two minutes before inserting the patient's vascular needles، after cleaning the skin of the needle entry area, two puffs of 10% Lidocaine spray (20 mg) will be sprayed from a distance of 5 cm on the skin surface where the needle enters. 5 minutes after using Lidocaine spray while disinfecting the skin at the site of arterial needle entry with 70% alcohol، the Hemodialysis needle is inserted into the arteries of the fistula area by the ward nurse.This intervention will be repeated three times in a row Hemodialysis on patients in this group. "Pain score in Visual َAnalogue Scale Questionnaire". Timepoint: "Evaluation of pain score before the intervention and then three consecutive Hemodialysis sessions in both groups". Method of measurement: " Visual Analogue Scale Questionnaire ". Gonabad University of Medical Sciences Approved 2021-06-23 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)