Phlebitis After InfusionNCT05326568
Effect of Sesame Oil in Preventing Phlebitis
A study testing Complementary treatment practice in people with Phlebitis After Infusion, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Phlebitis After Infusion
- What is being tested?
- Complementary treatment practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2023to 15 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Phlebitis After Infusion
- Being tested
- Complementary treatment practice
- Keywords
- aromatherapy, amiodarone infusion, phlebitis, cardiac surgery, Sesame oil
- Medical subject headings
- Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complementary treatment practiceOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Complementary treatment practice |
| Control | No intervention | No treatment was applied to the patients assigned to the control group and only standard care was applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from 1st day to 2nd day, and 3rd day after the implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start15 Jun 2023
- Primary completion18 Jun 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phlebitis After InfusionStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, parallel, two-arm randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muaz Gulsen, Cukurova University
- Investigators
- Sevban ARSLAN, PhD, Study director, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326568
- Sponsor's protocol ID
- CukurovaUnıversıty-Mgulsen-01
- Status last verified
- Nov 2023
- First submitted
- 6 Apr 2022
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sesame Oil on the Prevention of Phlebitis in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05326568
- Acronym / sponsor ID
- CukurovaUnıversıty-Mgulsen-01
- Conditions
- Phlebitis After Infusion
- Keywords
- aromatherapy, amiodarone infusion, phlebitis, cardiac surgery, Sesame oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 18 Jun 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, parallel, two-arm randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Complementary treatment practiceSesame 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. |
| Control | No intervention | –No treatment was applied to the patients assigned to the control group and only standard care was applied. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complementary treatment practiceApplying 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 | Other | Experimental |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevban ARSLAN, PhD study director
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complementary treatment practice in people with Phlebitis After Infusion, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Infusion Phlebitis Scale (time frame: Change from 1st day to 2nd day, and 3rd day after the implementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.