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Effect of Sesame Oil in Preventing Phlebitis

NCT ID: NCT05326568

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2023-10-15

Brief Summary

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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

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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.

Conditions

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Phlebitis After Infusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, parallel, two-arm randomized controlled clinical trial
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
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Study Groups

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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.

Group Type EXPERIMENTAL

Complementary treatment practice

Intervention Type 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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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Muaz Gulsen

Academic Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sevban ARSLAN, PhD

Role: STUDY_DIRECTOR

Cukurova University

Locations

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Muaz GÜLŞEN

Adana, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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CukurovaUnıversıty-Mgulsen-01

Identifier Type: -

Identifier Source: org_study_id