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Effect of Sesame Oil in Preventing Phlebitis

Primary Purpose

Phlebitis After Infusion

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Complementary treatment practice
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Phlebitis After Infusion focused on measuring aromatherapy, amiodarone infusion, phlebitis, cardiac surgery, Sesame oil

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who had undergone cardiac surgery,
  • were over 18 years old,
  • were conscious, could communicate,
  • were not allergic to sesame,
  • were administered prophylactic rhythm regulator
  • amiodarone as a treatment were included in the study.

Exclusion Criteria:

  • who was with cancer,
  • who was with diabetes mellitus,
  • who was with hypertension
  • who was with peripheral vascular disease
  • Patients who had myocardial infarction during the procedure,
  • Received immunosuppressive therapy,
  • underwent resuscitation and could not use an intravenous catheter for any reason

Sites / Locations

  • Muaz GÜLŞEN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control

Arm Description

Sesame oil was applied by the researcher to the patients assigned to the intervention group. Sesame oil was applied to the 10 cm circumference of the cannula, in the form of 10 drops and 10 minutes.

No treatment was applied to the patients assigned to the control group and only standard care was applied.

Outcomes

Primary Outcome Measures

Visual Infusion Phlebitis Scale
The scale monitors the potential risks of the catheter when administering peripheral venous therapy and rates the developmental stages of phlebitis. Scores range from 0-4. A score of zero indicates that there are no signs of phlebitis, and a score of four indicates that the phlebitis is in the last stage.

Secondary Outcome Measures

Full Information

First Posted
April 6, 2022
Last Updated
October 2, 2023
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05326568
Brief Title
Effect of Sesame Oil in Preventing Phlebitis
Official Title
The Effect of Sesame Oil on the Prevention of Phlebitis in Patients Undergoing Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
August 15, 2023 (Actual)
Study Completion Date
August 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova 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
Background: To determine the effect of sesame oil in preventing phlebitis that may occur during intravenous therapy in patients undergoing cardiac surgery. Material and Method: A randomized controlled interventional study will be conducted with patients treated in the coronary intensive care unit of a university hospital. The population of the study will be the patients hospitalized in the intensive care unit after cardiac surgery and administered parenteral amiodarone infusion. The power analysis was carried out by taking the study by. The sample size was determined as 44 patients. Personal Information Form and Visual Infusion Phlebitis Scale will be used to collect data. Sesame oil will be applied to the patients in the intervention group as 10 drops, 10 cm around the cannula, for 10 minutes. This administration will be repeated every eight hours during the 24-hour amiodarone infusion. No application will be made by the researcher to the patients in the control group. At the end of each 24 hours, patients in both groups will be evaluated by the investigator on the Visual Infusion Phlebitis Scale. Descriptive statistics, chi square, independent t test and Fisher's exact test will be used to evaluate the data.
Detailed Description
No application was made to the patients assigned to the control group. Sesame oil was applied by the researcher to the patients assigned to the intervention group. Sesame oil was applied to the 10 cm circumference of the cannula by applying 10 drops and 10 minutes. This application was repeated every eight hours during the 24-hour amiodarone infusion. The area where the intravenous line is located is covered with a standard transparent dressing (Tegaderm) so that it can be observed. Patients in the intervention and control groups were evaluated for phlebitis at the end of every 24 hours (1st day, 2nd day, 3rd day) according to the VIP scale. The highest of the phlebitis stages obtained as a result of the evaluation was accepted as the final evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phlebitis After Infusion
Keywords
aromatherapy, amiodarone infusion, phlebitis, cardiac surgery, Sesame oil

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, parallel, two-arm randomized controlled clinical trial
Masking
Outcomes Assessor
Masking Description
After the research report is written, a third person will assign an intervention and control group to the letters.
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Sesame oil was applied by the researcher to the patients assigned to the intervention group. Sesame oil was applied to the 10 cm circumference of the cannula, in the form of 10 drops and 10 minutes.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No treatment was applied to the patients assigned to the control group and only standard care was applied.
Intervention Type
Other
Intervention Name(s)
Complementary treatment practice
Intervention Description
Applying sesame oil to the patients assigned to the intervention group by applying 10 drops to the 10 cm circumference of the cannula for 10 minutes
Primary Outcome Measure Information:
Title
Visual Infusion Phlebitis Scale
Description
The scale monitors the potential risks of the catheter when administering peripheral venous therapy and rates the developmental stages of phlebitis. Scores range from 0-4. A score of zero indicates that there are no signs of phlebitis, and a score of four indicates that the phlebitis is in the last stage.
Time Frame
Change from 1st day to 2nd day, and 3rd day after the implementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who had undergone cardiac surgery, were over 18 years old, were conscious, could communicate, were not allergic to sesame, were administered prophylactic rhythm regulator amiodarone as a treatment were included in the study. Exclusion Criteria: who was with cancer, who was with diabetes mellitus, who was with hypertension who was with peripheral vascular disease Patients who had myocardial infarction during the procedure, Received immunosuppressive therapy, underwent resuscitation and could not use an intravenous catheter for any reason
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevban ARSLAN, PhD
Organizational Affiliation
Cukurova University
Official's Role
Study Director
Facility Information:
Facility Name
Muaz GÜLŞEN
City
Adana
ZIP/Postal Code
01250
Country
Turkey

12. IPD Sharing Statement

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Effect of Sesame Oil in Preventing Phlebitis

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