xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06030141</url>
    </required_header>
    <id_info>
      <org_study_id>KSBUHSU</org_study_id>
      <nct_id>NCT06030141</nct_id>
    </id_info>
    <brief_title>Investigation of the Effect of Nigella Sativa Oil and Sesame Oil in Preventing Phlebitis</brief_title>
    <official_title>Investigation of the Effect of Nigella Sativa Oil and Sesame Oil in Preventing Phlebitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kutahya Health Sciences University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kutahya Health Sciences University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Phlebitis is an inflammatory reaction of the venous system and surrounding tissues that may&#xD;
        be associated with mechanical, chemical or infectious microorganisms; It is the most common&#xD;
        complication of intravenous injection. Symptoms of phlebitis; local pain, swelling, warmth,&#xD;
        erythema, tenderness; prominent redness and palpable firmness and purulent discharge along&#xD;
        the vascular access.&#xD;
  &#xD;
        Phlebitis is the most important peripheral intravenous catheter-related complication and is&#xD;
        seen in 0.1%- 63.3% of patients with peripheral intravenous catheters. Intravenous amiodarone&#xD;
        is an important treatment for arrhythmias. However, peripheral infusion causes direct&#xD;
        irritation of the vessel walls. Intravenous amiodarone is one of the most widely used&#xD;
        antiarrhythmics for the treatment of atrial fibrillation with rapid ventricular response.&#xD;
  &#xD;
        However, peripheral infusion of amiodarone usually causes pain during the infusion followed&#xD;
        by phlebitis. Peripheral intravenous infusion of amiodarone associated with phlebitis is&#xD;
        common in clinical practice, with an incidence of 5% to 65%.&#xD;
  &#xD;
        Herbal treatment is a popular method in recent years In recent studies to prevent phlebitis,&#xD;
        it has been determined that topical application of sesame oil and black cumin oil is&#xD;
        effective in preventing phlebitis.&#xD;
  &#xD;
        Sesame oil has antioxidant, anti-inflammatory and antibacterial properties and contains&#xD;
        several lignans such as sesamin and sesaminol that inhibit inflammation, including&#xD;
        interleukin 8 and endothelin 1. The therapeutic properties of black seed oil are due to the&#xD;
        presence of phenolic compounds, especially thymoquinone. The anti-inflammatory mechanism of&#xD;
        action of black seed oil occurs by inhibiting cyclo-oxygenase and 5-lipoxygenase pathways and&#xD;
        preventing the production of thromboxane B2 and leukotriene B4.&#xD;
  &#xD;
        There is no study in the literature comparing the effects of sesame oil and black cumin oil&#xD;
        to prevent phlebitis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        hlebitis is an inflammatory reaction of the venous system and surrounding tissues that may be&#xD;
        associated with mechanical, chemical or infectious microorganisms; It is the most common&#xD;
        complication of intravenous injection. Symptoms of phlebitis; local pain, swelling, warmth,&#xD;
        erythema, tenderness; prominent redness and palpable firmness and purulent discharge along&#xD;
        the vascular access.&#xD;
  &#xD;
        Phlebitis is the most important peripheral intravenous catheter-related complication and is&#xD;
        seen in 0.1%- 63.3% of patients with peripheral intravenous catheters. Intravenous amiodarone&#xD;
        is an important treatment for arrhythmias. However, peripheral infusion causes direct&#xD;
        irritation of the vessel walls. Intravenous amiodarone is one of the most widely used&#xD;
        antiarrhythmics for the treatment of atrial fibrillation with rapid ventricular response.&#xD;
  &#xD;
        However, peripheral infusion of amiodarone usually causes pain during the infusion followed&#xD;
        by phlebitis. Peripheral intravenous infusion of amiodarone associated with phlebitis is&#xD;
        common in clinical practice, with an incidence of 5% to 65%.&#xD;
  &#xD;
        Herbal treatment is a popular method in recent years In recent studies to prevent phlebitis,&#xD;
        it has been determined that topical application of sesame oil and black cumin oil is&#xD;
        effective in preventing phlebitis.&#xD;
  &#xD;
        Sesame oil has antioxidant, anti-inflammatory and antibacterial properties and contains&#xD;
        several lignans such as sesamin and sesaminol that inhibit inflammation, including&#xD;
        interleukin 8 and endothelin 1. The therapeutic properties of black seed oil are due to the&#xD;
        presence of phenolic compounds, especially thymoquinone. The anti-inflammatory mechanism of&#xD;
        action of black seed oil occurs by inhibiting cyclo-oxygenase and 5-lipoxygenase pathways and&#xD;
        preventing the production of thromboxane B2 and leukotriene B4.&#xD;
  &#xD;
        There is no study in the literature comparing the effects of sesame oil and black cumin oil&#xD;
        to prevent phlebitis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 25, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 25, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <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.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>visual infusion phlebitis scale</measure>
      <time_frame>Phlebitis formation is not expected during the follow-up period (72 hours) in the nigella sativa oil applied group.</time_frame>
      <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)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>visual infusion phlebitis scale</measure>
      <time_frame>Phlebitis formation is not expected during the follow-up period (72 hours) in the nigella sativa oil applied group.</time_frame>
      <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)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>visual infusion phlebitis scale</measure>
      <time_frame>Phlebitis formation is expected during the follow-up period (72 hours) in the control group.</time_frame>
      <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).</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">108</enrollment>
    <condition>Phlebitis</condition>
    <condition>Peripheral Venous Catheterization</condition>
    <arm_group>
      <arm_group_label>nigella sativa oil application group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.&#xD;
  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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sesame oil application group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.&#xD;
  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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>sesame oil application</intervention_name>
      <description>sesame oil application</description>
      <arm_group_label>Sesame oil application group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>nigella sativa oil application</intervention_name>
      <description>nigella sativa oil application</description>
      <arm_group_label>nigella sativa oil application group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years and over,&#xD;
  &#xD;
            -  IV amiodarone treatment was started,&#xD;
  &#xD;
            -  PIC applied to the cephalic or basilic vein,&#xD;
  &#xD;
            -  Number 20 catheter is preferred in PIC application,&#xD;
  &#xD;
            -  At least primary school graduate and can speak Turkish,&#xD;
  &#xD;
            -  Patients who voluntarily agree to participate in the study will be included in the&#xD;
               study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed with active phlebitis,&#xD;
  &#xD;
            -  Having a diagnosis of mental illness or communication problems,&#xD;
  &#xD;
            -  Hearing and vision problems,&#xD;
  &#xD;
            -  Skin integrity is impaired,&#xD;
  &#xD;
            -  Having a body temperature above 38.5 Cº,&#xD;
  &#xD;
            -  Stating that he is allergic to sesame oil and black cumin oil,&#xD;
  &#xD;
            -  Receiving irritant medication or liquid other than Amiodarone through the catheter,&#xD;
  &#xD;
            -  Receiving long-term IV therapy from cephalic or basilic veins,&#xD;
  &#xD;
            -  Mastectomy surgery, fistula,&#xD;
  &#xD;
            -  who have been diagnosed with SVO,&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>BURCU NAL</last_name>
      <phone>05077769735</phone>
      <email>burcu.nal@ksbu.edu.tr</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kutahya Health Sciences University</investigator_affiliation>
      <investigator_full_name>Burcu NAL</investigator_full_name>
      <investigator_title>LECTURER</investigator_title>
    </responsible_party>
    <keyword>Phlebitis</keyword>
    <keyword>nigella sativa oil</keyword>
    <keyword>sesame oil</keyword>
    <keyword>Peripheral Venous Catheterization</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Phlebitis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06030141
  org study id: KSBUHSU
  nct id: NCT06030141
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  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
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: visual infusion phlebitis scale
  time frame: Phlebitis formation is not expected during the follow-up period (72 hours) in the nigella sativa oil applied group.
  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)
  measure: visual infusion phlebitis scale
  time frame: Phlebitis formation is not expected during the follow-up period (72 hours) in the nigella sativa oil applied group.
  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)
  measure: visual infusion phlebitis scale
  time frame: Phlebitis formation is expected during the follow-up period (72 hours) in the control group.
  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).
  arm group label: nigella sativa oil application group
  arm group type: Experimental
  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 group label: Sesame oil application group
  arm group type: Experimental
  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 group label: control group
  arm group type: No Intervention
  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: sesame oil application
  description: sesame oil application
  arm group label: Sesame oil application group
  intervention type: Other
  intervention name: nigella sativa oil application
  description: nigella sativa oil application
  arm group label: nigella sativa oil application group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: BURCU NAL
  phone: 05077769735
  email: burcu.nal@ksbu.edu.tr
  responsible party type: Principal Investigator
  investigator affiliation: Kutahya Health Sciences University
  investigator full name: Burcu NAL
  investigator title: LECTURER
  mesh term: Phlebitis
  sharing ipd: No