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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06030141
Other study ID # KSBUHSU
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 15, 2023
Est. completion date September 1, 2024

Study information

Verified date December 2023
Source Kutahya Health Sciences University
Contact BURCU NAL
Phone 05077769735
Email burcu.nal@ksbu.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 108
Est. completion date September 1, 2024
Est. primary completion date August 25, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 CÂș, - 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,

Study Design


Related Conditions & MeSH terms

  • Peripheral Venous Catheterization
  • Phlebitis

Intervention

Other:
sesame oil application
sesame oil application
nigella sativa oil application
nigella sativa oil application

Locations

Country Name City State
Turkey Kütahya Health Sciences University Training and Research Hospital Merkez Kütahya

Sponsors (1)

Lead Sponsor Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Phlebitis formation is not expected during the follow-up period (72 hours) in the nigella sativa oil applied group.
Primary 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) Phlebitis formation is not expected during the follow-up period (72 hours) in the nigella sativa oil applied group.
Primary 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). Phlebitis formation is expected during the follow-up period (72 hours) in the control group.
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