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CompletedNCT05326568Updated Nov 24, 2023

Effect of Sesame Oil in Preventing Phlebitis

An interventional study of Complementary treatment practice in Phlebitis After Infusion, sponsored by Cukurova University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-24.

Sponsored by Cukurova University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Phlebitis After Infusion

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Keywords

  • aromatherapy
  • amiodarone infusion
  • phlebitis
  • cardiac surgery
  • Sesame oil
03

In context

Phlebitis

45 studies on the registry are indexed under Phlebitis; 9 are open to participants now.

This study's enrollment of 44 is below the median of 134 across 38 interventional studies indexed under Phlebitis.

Browse Phlebitis studies →

Lead sponsor

Cukurova University is the lead sponsor of 259 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 therapy,
  • underwent resuscitation and could not use an intravenous catheter for any reason
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • 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

  • No intervention
    Control

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

Interventions

  • OtherComplementary 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from 1st day to 2nd day, and 3rd day after the implementation

07

Study locations

1 site
  • Muaz GÜLŞEN
    Adana, 01250, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05326568
Responsible party
Muaz Gulsen (Academic Lecturer, Cukurova University) — Principal investigator
First posted
Apr 13, 2022
Start date
Jun 15, 2023
Primary completion
Jun 18, 2023
Completion
Oct 15, 2023
Last update
Nov 24, 2023

Study contacts

Sevban ARSLAN, PhD
study director · Cukurova University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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