Effect of Sesame Oil in Preventing Phlebitis

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.

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Key information

Conditions

Phlebitis After Infusion Cardiovascular Diseases Peripheral Vascular Diseases Phlebitis Vascular Diseases Vasculitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Muaz GÜLŞEN

Adana, 01250, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Complementary treatment practice

Other

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Apr 13, 2022
Registry last updated: Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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