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IRCT20191028045263N1 IRCT 2020-01-06 Ahvaz University of Medical Sciences The Effect of Rosemary Essential Oil on Severity of Inflammation and Pain Due to Needle Entry to Intravenous Arterial Fistula in Hemodialysis Patients The effect of topical application of Rosemary essential oil on the severity of inflammation and pain induced by needle insertion into arterial venous fistula in patients undergoing chronic hemodialysis 2019-11-21 anticipated 60 Complete https://irct.ir/trial/43350 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomized block design will be assigned to two intervention and control groups. Four blocks will be used in this study and the numbers will be assigned to them according to the following list (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)) Then select random numbers from one to 6 (eg 1 4 5 and ...) and randomization will continue until the last participant. 3 Severity of pain and inflammation induced by needle insertion into venous arterial fistula in patients undergoing chronic hemodialysis. Intervention 1: Intervention group: The researcher will use 3 puffs of rosemary essential oil 5 minutes before hemodialysis at the time of intervention. After 5 minutes, the injection site will be disinfected with alcohol and the needle will be inserted. To control for confounding factors, the entire process of needle placement in the fistula will be performed by four nurses with at least six months of dialysis and researcher supervision. The type of needle will be the same in size, shape and manufacturer. Also, the needle will be placed in the fistula for all specimens with a 20-30 degree angle. The intervention will last for six sessions. Intervention 2: Control group: In the control group water spray is used, three puffs are sprayed at the needle insertion place for six intermittent sessions. 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 No more information
public Roya Maramazi
No.51,fifteen Ave.,kianpars Blvd.,Ahwaz Town
Ahwaz Iran (Islamic Republic of) 6155873687 +98 61 3391 8993 roya0939590@yahoo.com Ahvaz University of Medical Sciences scientific Roya Maramazi
Kianpars,15 st.
Ahvaz Iran (Islamic Republic of) 6155873687 +98 61 3391 8993 roya0939590@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Having Intravenous artery fistula Six month after fistula fixation Having three dialysis sessions in a week 18 years no limit Both Suffering Peripheral vascular disease Suffering Leukemia and acquired immune deficiency Patient dissatisfaction Other Other Intervention group: The researcher will use 3 puffs of rosemary essential oil 5 minutes before hemodialysis at the time of intervention. After 5 minutes, the injection site will be disinfected with alcohol and the needle will be inserted. To control for confounding factors, the entire process of needle placement in the fistula will be performed by four nurses with at least six months of dialysis and researcher supervision. The type of needle will be the same in size, shape and manufacturer. Also, the needle will be placed in the fistula for all specimens with a 20-30 degree angle. The intervention will last for six sessions Control group: In the control group water spray is used, three puffs are sprayed at the needle insertion place for six intermittent sessions. Severity of pain induced by needle insertion into arterial venous fistula. Timepoint: Before intervention and during next six sessions of dialysis. Method of measurement: Iran phlebitis checklist and Visual Analogue Scale. Severity of inflammation induced by needle insertion into arterial venous fistula. Timepoint: Before intervention and during next six sessions of dialysis. Method of measurement: Iran phlebitis checklist and Visual Analogue Scale. Ahvaz University of Medical Sciences Approved 2019-10-25 Ethics committee of Ahwaz University of Medical Sciences No.51,fifteen Ave.,kianpars Blvd.,Ahwaz Town Ahwaz Khouzestan Iran (Islamic Republic of)