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IRCT20171212037847N2 IRCT 2024-12-22 Isfahan University of Medical Sciences Comparison of the effect of EMLA cream, lidocaine spray with and without aromatherapy with lavender on pain during Arterio-Venous Fistula (AVF) cannulation among patients undergoing hemodialysis Comparison of the effect of EMLA cream, lidocaine spray with and without aromatherapy with lavender on pain during Arterio-Venous Fistula (AVF) cannulation among patients undergoing hemodialysis 2024-03-05 anticipated 30 Complete https://irct.ir/trial/75198 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: There is no specific case, Randomization description: In this research, the researcher uses the easy sampling method, so that among the available samples, patients who meet the criteria for entering this study are selected so that the samples reach the desired number, and then the samples are divided into two groups. The form of random allocation is done using mini-pie software. After minimization software divides the samples among the groups in such a way that there is a minimum difference between them, thus homogenization of the samples is also done and the confounding variables are under control. The desired variables to enter the software include (age, sex, duration of fistula placement and duration of hemodialysis), Blinding description: In this research, the VAS scale is used as a criterion for measuring the pain level of patients. After being at the patient's bedside, the researcher assistant asked the patients to choose the intensity of their pain and draw a line around the desired number. Also, in the data analysis stage, the type of intervention and the intervention and control groups are not known. 3 Chronic kidney disease, stage 5. Intervention 1: Intervention group: Intervention group: First, the patients are asked to express their experienced pain based on the visual analogue pain measurement scale in the first three sessions, immediately and 30 minutes after cannulation of the arteriovenous fistula using a routine method without intervention, and the data collected and recorded. Then, during cannulation, lidocaine spray, spelled cream or aromatherapy with lavender is used for all patients, or a combination of aromatherapy and lidocaine spray and a combination of aromatherapy and spelled cream. The duration of each intervention is 3 days. And there is a 48-hour cleaning period between interventions (patients are treated with hemodialysis three times a week, so there is a 48-hour cleaning period between sessions). It should be noted that the order and sequence of interventions is determined randomly for each patient. In this way, the names of 4 interventions are placed in 4 envelopes and the patients are asked to choose one of the envelopes randomly. choose, the first envelope is the first intervention that is done for the patient, then the patient is asked to choose one of the 3 envelopes, the second envelope that is chosen by the patient is the second intervention that is given to the patient Then the patient is asked to choose one of the remaining 2 envelopes, and thus the third intervention is determined, and the last remainingMethod of Spraying Lidocaine:In the lidocaine spray method, the skin is prepared initially and, then, the researcher sprays two puffs of 2% lidocaine (20 mg) onto the skin from a distance of 5 cm. After a five-minute interval, the skin surface around the fistula is disinfected using cotton pads soaked in 70% alcohol, and specialized hemodialysis needles are inserted into the veins of the fistula area by the nurse .Method of Using Emla Cream:For using Emla cream, two ml of Emla cream, based on the instructions for using the product, is applied 45 to 60 minutes before inserting the needle into the fistula and is fixed with a protective dressing. After 45 minutes, the Emla cream is removed from the skin and after disinfecting the area with cotton pads soaked in 70% alcohol, specialized hemodialysis needles are inserted in the veins of the fistula area by the nurse (9). Two minutes and 30 seconds after inserting the arterial needles, the pain intensity is measured by the nurse using a numerical pain intensity scale. To ensure that the previous intervention does not interfere, the interval between interventions is considered .Method of Using Lavender Aromatherapy:In this method, lavender oil is diluted with distilled water/sweet almond oil in a ratio of 1 to 10 (lavender oil 10% produced by Barij Essense Pharmaceutical Company) and, then, three drops of diluted lavender oil is placed on a piece of cotton and the patient is asked to breathe slowly from a distance of 7 to 10 cm and inhale it for 5 minutesLavender oil is typically stored in dark glass bottles with tightly closed lids and is kept in a cool environment, ensuring that no essential oil properties are lost. To assess the long-term effects of lavender oil inhalation, three hemodialysis sessions are implemented per week, and lavender oil inhalation is performed before each hemodialysis session . envelope is the last intervention that will be performed for the patient. Intervention 2: Control group: In the non-intervention method, the arterial-venous hemodialysis needles are inserted into the fistula area by the nurse and, after finishing the work and fixing the needles, the pain is measured and its level felt by the patient during the insertion of the arterial-venous needles is marked and recorded. The level of pain is measured only the first time the nurse inserts any of the arterial or venous needles. If the needles are not initially placed correctly and the nurse needs to make another attempt by piercing the skin again, the patient's pain level will not be measured. 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 In the consent form, the personal information of the patients remains confidential
public Maryam Sadat Hashemi
Hezarjarib avenue,Isfahan,Iran.
Isfahan Iran (Islamic Republic of) 009832253349 +98 913 411 8910 Maryam.hashemi@nm.mui.ac.ir Isfahan University of Medical Sciences scientific Maryam Sadat Hashemi
Hezarjarib avenue,Isfahan,Iran.
Isfahan Iran (Islamic Republic of) 00988199875784 +98 913 411 8910 Maryam.hashemi@nm.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Suffering from the final stage of chronic kidney disease 8 years old and older Being under dialysis for more than 3 months No participation in similar research programs at the same time Being conscious Being able to communicate verbally Passage of 3 months after fistula creation and having an efficient fistula 18 years no limit Both History of addiction and smoking Presence of skin and vascular lesions in the involved limb Allergy to lidocaine, prilocaine, or other local anesthetics Allergy to essential oils History of asthma, bronchitis, and chronic respiratory diseases Smell problems Severe pain in other organs N18.5 Chronic kidney disease, stage 5 Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: First, the patients are asked to express their experienced pain based on the visual analogue pain measurement scale in the first three sessions, immediately and 30 minutes after cannulation of the arteriovenous fistula using a routine method without intervention, and the data collected and recorded. Then, during cannulation, lidocaine spray, spelled cream or aromatherapy with lavender is used for all patients, or a combination of aromatherapy and lidocaine spray and a combination of aromatherapy and spelled cream. The duration of each intervention is 3 days. And there is a 48-hour cleaning period between interventions (patients are treated with hemodialysis three times a week, so there is a 48-hour cleaning period between sessions). It should be noted that the order and sequence of interventions is determined randomly for each patient. In this way, the names of 4 interventions are placed in 4 envelopes and the patients are asked to choose one of the envelopes randomly. choose, the first envelope is the first intervention that is done for the patient, then the patient is asked to choose one of the 3 envelopes, the second envelope that is chosen by the patient is the second intervention that is given to the patient Then the patient is asked to choose one of the remaining 2 envelopes, and thus the third intervention is determined, and the last remainingMethod of Spraying Lidocaine:In the lidocaine spray method, the skin is prepared initially and, then, the researcher sprays two puffs of 2% lidocaine (20 mg) onto the skin from a distance of 5 cm. After a five-minute interval, the skin surface around the fistula is disinfected using cotton pads soaked in 70% alcohol, and specialized hemodialysis needles are inserted into the veins of the fistula area by the nurse .Method of Using Emla Cream:For using Emla cream, two ml of Emla cream, based on the instructions for using the product, is applied 45 to 60 minutes before inserting the needle into the fistula and is fixed with a protective dressing. After 45 minutes, the Emla cream is removed from the skin and after disinfecting the area with cotton pads soaked in 70% alcohol, specialized hemodialysis needles are inserted in the veins of the fistula area by the nurse (9). Two minutes and 30 seconds after inserting the arterial needles, the pain intensity is measured by the nurse using a numerical pain intensity scale. To ensure that the previous intervention does not interfere, the interval between interventions is considered .Method of Using Lavender Aromatherapy:In this method, lavender oil is diluted with distilled water/sweet almond oil in a ratio of 1 to 10 (lavender oil 10% produced by Barij Essense Pharmaceutical Company) and, then, three drops of diluted lavender oil is placed on a piece of cotton and the patient is asked to breathe slowly from a distance of 7 to 10 cm and inhale it for 5 minutesLavender oil is typically stored in dark glass bottles with tightly closed lids and is kept in a cool environment, ensuring that no essential oil properties are lost. To assess the long-term effects of lavender oil inhalation, three hemodialysis sessions are implemented per week, and lavender oil inhalation is performed before each hemodialysis session . envelope is the last intervention that will be performed for the patient. Control group: In the non-intervention method, the arterial-venous hemodialysis needles are inserted into the fistula area by the nurse and, after finishing the work and fixing the needles, the pain is measured and its level felt by the patient during the insertion of the arterial-venous needles is marked and recorded. The level of pain is measured only the first time the nurse inserts any of the arterial or venous needles. If the needles are not initially placed correctly and the nurse needs to make another attempt by piercing the skin again, the patient's pain level will not be measured. Pain. Timepoint: In 2 occasions, immediately and half an hour after cannulation for 3 days. Method of measurement: Visual Analogue Scale. Comfort. Timepoint: immediately and half an hour after cannulation for 3 days. Method of measurement: Hemodialysis Comfort Scale. Isfahan University of Medical Sciences Approved 2024-05-19 Ethics committee of Isfahan University of Medical Sciences Hezarjarib avenue,Isfahan,Iran. Isfahan Isfehan Iran (Islamic Republic of)