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

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.

Study Overview

• Status: Recruiting
• Conditions: Phlebitis; Peripheral Venous Catheterization
• Intervention / Treatment: Other: nigella sativa oil application; Other: sesame oil application

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.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: BURCU NAL; Phone Number: 05077769735; Email: burcu.nal@ksbu.edu.tr

Study Locations

• Turkey
  • Kütahya
    • Merkez, Kütahya, Turkey, 43200
      • Recruiting
      • Kütahya Health Sciences University Training and Research Hospital
      • Contact: BURCU NAL
      • Sub-Investigator: DİLEK SARI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nigella sativa oil application group; 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; nigella sativa oil application
Experimental: Sesame oil application group; 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; sesame oil application
No Intervention: control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): August 25, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Phlebitis; sesame oil; Peripheral Venous Catheterization; nigella sativa oil
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Vasculitis; Peripheral Vascular Diseases; Phlebitis
• Other Study ID Numbers: KSBUHSU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No