Effect of Sesame Oil in Preventing Phlebitis

October 2, 2023 updated by: Muaz Gulsen, Cukurova University

The Effect of Sesame Oil on the Prevention of Phlebitis in Patients Undergoing Cardiac Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey, 01250
        • Muaz GÜLŞEN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
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.
Other: Complementary treatment practice
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
No Intervention: Control
No treatment was applied to the patients assigned to the control group and only standard care was applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Infusion Phlebitis Scale
Time Frame: Change from 1st day to 2nd day, and 3rd day after the implementation
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.
Change from 1st day to 2nd day, and 3rd day after the implementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Investigators

  • Study Director: Sevban ARSLAN, PhD, Çukurova University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2023

Primary Completion (Actual)

August 15, 2023

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

April 6, 2022

First Posted (Actual)

April 13, 2022

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CukurovaUnıversıty-Mgulsen-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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