Effect of Sesame Oil in Preventing Phlebitis

Sponsor

Cukurova University (Other)

Overall Status

Completed

CT.gov ID

NCT05326568

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Days)

44.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Phlebitis After Infusion	Other: Complementary treatment practice	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, parallel, two-arm randomized controlled clinical trialProspective, parallel, two-arm randomized controlled clinical trial

Masking:

Single (Outcomes Assessor)

Masking Description:

After the research report is written, a third person will assign an intervention and control group to the letters.

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 15, 2022

Actual Primary Completion Date :

May 15, 2022

Actual Study Completion Date :

May 15, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Visual Infusion Phlebitis Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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