An interventional study of sesame oil application and nigella sativa oil application in Phlebitis and Peripheral Venous Catheterization, sponsored by Kutahya Health Sciences University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-06.
Sponsored by Kutahya Health Sciences University · Not applicable, Interventional, and Prevention
Phlebitis is an inflammatory reaction of the venous system and surrounding tissues that may be associated with mechanical, chemical or infectious microorganisms; It is the most common complication of intravenous injection. Symptoms of phlebitis; local pain, swelling, warmth, erythema, tenderness; prominent redness and palpable firmness and purulent discharge along the vascular access.
Phlebitis is the most important peripheral intravenous catheter-related complication and is seen in 0.1%- 63.3% of patients with peripheral intravenous catheters. Intravenous amiodarone is an important treatment for arrhythmias. However, peripheral infusion causes direct irritation of the vessel walls. Intravenous amiodarone is one of the most widely used antiarrhythmics for the treatment of atrial fibrillation with rapid ventricular response.
However, peripheral infusion of amiodarone usually causes pain during the infusion followed by phlebitis. Peripheral intravenous infusion of amiodarone associated with phlebitis is common in clinical practice, with an incidence of 5% to 65%.
Herbal treatment is a popular method in recent years In recent studies to prevent phlebitis, it has been determined that topical application of sesame oil and black cumin oil is effective in preventing phlebitis.
Sesame oil has antioxidant, anti-inflammatory and antibacterial properties and contains several lignans such as sesamin and sesaminol that inhibit inflammation, including interleukin 8 and endothelin 1. The therapeutic properties of black seed oil are due to the presence of phenolic compounds, especially thymoquinone. The anti-inflammatory mechanism of action of black seed oil occurs by inhibiting cyclo-oxygenase and 5-lipoxygenase pathways and preventing the production of thromboxane B2 and leukotriene B4.
There is no study in the literature comparing the effects of sesame oil and black cumin oil to prevent phlebitis.
hlebitis is an inflammatory reaction of the venous system and surrounding tissues that may be associated with mechanical, chemical or infectious microorganisms; It is the most common complication of intravenous injection. Symptoms of phlebitis; local pain, swelling, warmth, erythema, tenderness; prominent redness and palpable firmness and purulent discharge along the vascular access.
Phlebitis is the most important peripheral intravenous catheter-related complication and is seen in 0.1%- 63.3% of patients with peripheral intravenous catheters. Intravenous amiodarone is an important treatment for arrhythmias. However, peripheral infusion causes direct irritation of the vessel walls. Intravenous amiodarone is one of the most widely used antiarrhythmics for the treatment of atrial fibrillation with rapid ventricular response.
However, peripheral infusion of amiodarone usually causes pain during the infusion followed by phlebitis. Peripheral intravenous infusion of amiodarone associated with phlebitis is common in clinical practice, with an incidence of 5% to 65%.
Herbal treatment is a popular method in recent years In recent studies to prevent phlebitis, it has been determined that topical application of sesame oil and black cumin oil is effective in preventing phlebitis.
Sesame oil has antioxidant, anti-inflammatory and antibacterial properties and contains several lignans such as sesamin and sesaminol that inhibit inflammation, including interleukin 8 and endothelin 1. The therapeutic properties of black seed oil are due to the presence of phenolic compounds, especially thymoquinone. The anti-inflammatory mechanism of action of black seed oil occurs by inhibiting cyclo-oxygenase and 5-lipoxygenase pathways and preventing the production of thromboxane B2 and leukotriene B4.
There is no study in the literature comparing the effects of sesame oil and black cumin oil to prevent phlebitis.
45 studies on the registry are indexed under Phlebitis; 9 are open to participants now.
This study's enrollment of 108 is below the median of 134 across 38 interventional studies indexed under Phlebitis.
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Exclusion Criteria:
Peripheral venous catheter is applied under aseptic conditions. In order to easily see whether phlebitis occurs in the catheter area, the area where the catheter is inserted is covered with a Tegaderm transparent film cover and the catheter is fixed. Determine the distal peripheral venous catheter (3.2 cm length from the entry point for catheter 20) An area of 10 cm will be determined from the distal of the catheter. Nigella sativa oil is dripped 5 drops on a 10 cm area. The dripped oil is applied without massaging, Nigella Sativa oil will be applied to the patients in the application group before the start of amiodarone infusion and at 6-hour intervals. The patients in all groups will be evaluated with the GIFTS scale for phlebitis every hour for the first 25 hours from the time of opening the catheter, and every 6 hours for the next 48 hours.
Other: nigella sativa oil application
Peripheral venous catheter is applied under aseptic conditions. In order to easily see whether phlebitis occurs in the catheter area, the area where the catheter is inserted is covered with a Tegaderm transparent film cover and the catheter is fixed. Determine the distal peripheral venous catheter (3.2 cm length from the entry point for catheter 20) An area of 10 cm will be determined from the distal of the catheter. Sesame oil is dripped 5 drops on a 10 cm area. The dripped oil is applied without massaging, The dripped oil is applied without massaging, Sesame oil will be applied to the patients in the application group before the start of amiodarone infusion and at 6-hour intervals. The patients in all groups will be evaluated with the GIFTS scale for phlebitis every hour for the first 25 hours from the time of opening the catheter, and every 6 hours for the next 48 hours.
Other: sesame oil application
Peripheral venous catheter is applied under aseptic conditions. In order to easily see whether phlebitis occurs in the catheter area, the area where the catheter is inserted is covered with a Tegaderm transparent film cover and the catheter is fixed. No oil application will be made. The patients in all groups will be evaluated with the GIFTS scale for phlebitis every hour for the first 25 hours from the time of opening the catheter, and every 6 hours for the next 48 hours.
sesame oil application
nigella sativa oil application
visual infusion phlebitis scale
The scale has Turkish validity and durability.No change is expected in the Visual Infusion Phlebitis Scale score (2 points and above) in the sesame oil administration group (36 individual)
Time frame: Phlebitis formation is not expected during the follow-up period (72 hours) in the nigella sativa oil applied group.
visual infusion phlebitis scale
The scale has Turkish validity and durability.No change is expected in the Visual Infusion Phlebitis Scale score (2 points and above) in the nigella sativa oil administration group (36 individual)
Time frame: Phlebitis formation is not expected during the follow-up period (72 hours) in the nigella sativa oil applied group.
visual infusion phlebitis scale
The scale has Turkish validity and durability.Changes in the Visual Infusion Phlebitis Scale score (2 points and above) are expected in the control group (36 individuals).
Time frame: Phlebitis formation is expected during the follow-up period (72 hours) in the control group.
Plan to share: No
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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