Clinical trial NCT06030141: Investigation of the Effect of Nigella Sativa Oil and Sesame Oil in Preventing Phlebitis
Official title: Investigation of the Effect of Nigella Sativa Oil and Sesame Oil in Preventing Phlebitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phlebitis
Peripheral Venous Catheterization
Keywords: Phlebitis
nigella sativa oil
sesame oil
Peripheral Venous Catheterization
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, catheter application and follow-up will be carried out by the researcher Burcu Nal, and phlebitis evaluation will be made by a specialist nurse other than the researcher. Patients will be aware that they are included in the study, but they will be blinded as one of the oils applied in the care they will be given will be used by hiding the information of which group they are in. In order to prevent bias, patients will be included in the study groups according to the assignment made from the Randomizer.org program. Since the data will be transferred to the SPSS program and the analysis will be done by an independent statistician, the bias will also be controlled in the data evaluation process.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 18 years and over,
* IV amiodarone treatment was started,
* PIC applied to the cephalic or basilic vein,
* Number 20 catheter is preferred in PIC application,
* At least primary school graduate and can speak Turkish,
* Patients who voluntarily agree to participate in the study will be included in the study.

Exclusion Criteria:

* Diagnosed with active phlebitis,
* Having a diagnosis of mental illness or communication problems,
* Hearing and vision problems,
* Skin integrity is impaired,
* Having a body temperature above 38.5 Cº,
* Stating that he is allergic to sesame oil and black cumin oil,
* Receiving irritant medication or liquid other than Amiodarone through the catheter,
* Receiving long-term IV therapy from cephalic or basilic veins,
* Mastectomy surgery, fistula,
* who have been diagnosed with SVO,

Primary outcomes:
measure: visual infusion phlebitis scale
timeFrame: Phlebitis formation is not expected during the follow-up period (72 hours) in the nigella sativa oil applied group.
measure: visual infusion phlebitis scale
timeFrame: Phlebitis formation is not expected during the follow-up period (72 hours) in the nigella sativa oil applied group.
measure: visual infusion phlebitis scale
timeFrame: Phlebitis formation is expected during the follow-up period (72 hours) in the control group.
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Kütahya Health Sciences University Training and Research Hospital
state: Kütahya
Study officials:
References: