- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04796805
Effect of Topical Application of Black Pepper Essential Oil and Peripheral Catheter Insertion
Effect of Topical Application of Black Pepper Essential Oil on Peripheral Intravenous Catheter Insertion: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction: The literature describes many techniques to increase vein visibility and palpability that facilitate peripheral intravenous catheter insertion. However, there is only one study examining the effect of topical essential black pepper oil on veins. The investigators aimed to determine the effects of topical application of black pepper essential oil on peripheral intravenous catheter insertion success.
Methods: This randomized controlled trial was carried out on 60 patients randomly assigned to either the experimental group (n=30) or the control group (n=30) reporting to the endoscopy unit of the clinic between May 2019 and October 2019. The study results were evaluated using an information form, a catheter insertion form, and a visual analog scale (VAS). In the experimental group, black pepper essential oil was used to increase vein degree before the procedure, while in the control group, no extra interventions were applied. The time taken in determining an appropriate vein, time taken for successful catheter insertion, and the patient's and nurse's satisfaction after the process were recorded via a chronometer.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Yalova, Turkey, 77200
- Yalova University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Must be evaluable their veins as 1, 2 and 3 according to vein assessment scale Must be able to communicate
Exclusion Criteria:
Clinical diagnosis of peripheral vascular disease Clinical diagnosis of any other chronic illness (except cancer)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Essential oil application group
The experimental group received 20% black pepper essential oil in a base of aloe vera gel applied topically to the forearm using a rollerball 10 min before venipuncture.
Twelve swipes were applied using the rollerball applicator.
The maximum dose of the black pepper/aloe vera gel mixture was 3 mL.
Sphygmomanometer cuff was placed on the right arm, and the cuff was inflated until it reached the patient's diastolic blood pressure level.
When the pointer reached the desired value, the period was commenced by the researcher.
The nurse determined the right vein.
After selecting the right vein, the period was ended as the nurse successfully placed a catheter.
|
We applied black pepper essential oil to the participants in experimental group before the catheter insertion procedure
|
|
No Intervention: Control group
Diastolic blood pressure and body temperature of the patients in the control group were measured.
A sphygmomanometer cuff was placed on the arm that was not actively used by the patient.
Until the cuff's pointer reached the diastolic blood pressure level of the patient, it was inflated.
When the tip came to the desired value, the period was noted by the researcher.
Without any extra attempts being made, the catheter was placed by the nurse.
The period ended with the successful catheter placement by the nurse.
Period of appropriate vein selection, the period of placing the catheter successfully, patient and nurse satisfaction were recorded.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Period of the appropriate vein selection and successful catheter placement
Time Frame: 7 months
|
Time of the determining the appropriate vein and successful catheter placement
|
7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patients' and the nurses satisfaction level according to visual analog scale (0: I am not pleasured; 10: I am very pleasured)
Time Frame: 7 months
|
Patients' and the nurses satisfaction from peripheral intravenous catheter placement
|
7 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Handan Eren, PhD, Yalova University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Yalova University (Other Identifier: Yalova University Scientific Research Project)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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