Vein; SpasmNCT04796805
Effect of Topical Application of Black Pepper Essential Oil and Peripheral Catheter Insertion
A study testing Topical essential oil application in people with Vein; Spasm and Patient Satisfaction, run by University of Yalova at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to determine the effects of topical application of black pepper essential oil on peripheral intravenous catheter insertion success.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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vein; Spasm, Patient Satisfaction, Nurse Scope, Practice
- What is being tested?
- Topical essential oil application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2019to 1 Jan 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be evaluable their veins as 1, 2 and 3 according to vein assessment scale Must be able to communicate
Who cannot join
- Clinical diagnosis of peripheral vascular disease Clinical diagnosis of any other chronic illness (except cancer)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Topical Application of Black Pepper Essential Oil on Peripheral Intravenous Catheter Insertion: A Randomized Controlled Study
The investigators aimed to determine the effects of topical application of black pepper essential oil on peripheral intravenous catheter insertion success.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. 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.
Read the 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.
- Conditions
- Vein; Spasm, Patient Satisfaction, Nurse Scope, Practice
- Being tested
- Topical essential oil application
- Keywords
- essential oil application, catheter insertion
- Medical subject headings
- Spasm, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical essential oil applicationOther
We applied black pepper essential oil to the participants in experimental group before the catheter insertion procedure
| Study group | Role | What they receive |
|---|---|---|
| Essential oil application group | Experimental | 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. Receives: Other: Topical essential oil application |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Period of the appropriate vein selection and successful catheter placement
Time of the determining the appropriate vein and successful catheter placement
Measured: 7 months
Secondary outcomes (1)
Patients' and the nurses satisfaction level according to visual analog scale (0: I am not pleasured; 10: I am very pleasured)
Patients' and the nurses satisfaction from peripheral intravenous catheter placement
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start2 May 2019
- Primary completion9 Oct 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vein; SpasmStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Collaborators
- Karamanoğlu Mehmetbey University
- Responsible party
- Principal investigator, Handan Eren, University of Yalova
- Investigators
- Handan Eren, PhD, Principal investigator, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796805
- Sponsor's protocol ID
- Yalova University
- Status last verified
- Mar 2021
- First submitted
- 25 Feb 2021
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Application of Black Pepper Essential Oil on Peripheral Intravenous Catheter Insertion: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04796805
- Acronym / sponsor ID
- Yalova University
- Conditions
- Vein; Spasm, Patient Satisfaction, Nurse Scope, Practice
- Keywords
- essential oil application, catheter insertion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Collaborators
- Karamanoğlu Mehmetbey University
- Study start
- 2 May 2019 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 15 Mar 2021 (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.
The investigators aimed to determine the effects of topical application of black pepper essential oil on peripheral intravenous catheter insertion success.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. 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Essential oil application group | Experimental | Other: Topical essential oil applicationThe 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be evaluable their veins as 1, 2 and 3 according to vein assessment scale Must be able to communicate
Key exclusion criteria (1 listed)
- Clinical diagnosis of peripheral vascular disease Clinical diagnosis of any other chronic illness (except cancer)
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 |
|---|---|---|
| Topical essential oil applicationWe applied black pepper essential oil to the participants in experimental group before the catheter insertion procedure | Other | Essential oil application group |
Primary outcome
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
1 secondary outcome
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
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 16 Mar 2021.
- Individual participant dataSharing planned: Undecided
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.
Handan Eren, PhD principal investigator
University of Yalova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical essential oil application in people with Vein; Spasm and Patient Satisfaction, run by University of Yalova 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 1 inclusion and 1 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 16 Mar 2021. 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?
Period of the appropriate vein selection and successful catheter placement (time frame: 7 months). 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 16 Mar 2021.