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

Primary Purpose

Phlebitis, Peripheral Venous Catheterization

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sesame oil application
nigella sativa oil application
Sponsored by
Kutahya Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Phlebitis focused on measuring Phlebitis, nigella sativa oil, sesame oil, Peripheral Venous Catheterization

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    nigella sativa oil application group

    Sesame oil application group

    control group

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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)
    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)
    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    August 15, 2023
    Last Updated
    September 6, 2023
    Sponsor
    Kutahya Health Sciences University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06030141
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 25, 2023 (Anticipated)
    Primary Completion Date
    August 25, 2024 (Anticipated)
    Study Completion Date
    September 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kutahya Health Sciences University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Phlebitis, Peripheral Venous Catheterization
    Keywords
    Phlebitis, nigella sativa oil, sesame oil, Peripheral Venous Catheterization

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    108 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    nigella sativa oil application group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Sesame oil application group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    sesame oil application
    Intervention Description
    sesame oil application
    Intervention Type
    Other
    Intervention Name(s)
    nigella sativa oil application
    Intervention Description
    nigella sativa oil application
    Primary Outcome Measure Information:
    Title
    visual infusion phlebitis scale
    Description
    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.
    Title
    visual infusion phlebitis scale
    Description
    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.
    Title
    visual infusion phlebitis scale
    Description
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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,
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    BURCU NAL
    Phone
    05077769735
    Email
    burcu.nal@ksbu.edu.tr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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