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临床试验/NCT06030141
NCT06030141已完成不适用

Investigation of the Effect of Nigella Sativa Oil and Sesame Oil in Preventing Phlebitis

Kutahya Health Sciences University2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2023年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
108
试验地点
2
主要终点
visual infusion phlebitis scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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,

结局指标

主要结局

visual infusion phlebitis scale

时间窗: Phlebitis formation is expected during the follow-up period (72 hours) in the control group.

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).

次要结局

未报告次要终点

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

BURCU NAL

LECTURER

Kutahya Health Sciences University

研究点 (2)

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