NCT04796805

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

February 25, 2021

Last Update Submit

March 12, 2021

Conditions

Keywords

essential oil applicationcatheter insertion

Outcome Measures

Primary Outcomes (1)

  • Period of the appropriate vein selection and successful catheter placement

    Time of the determining the appropriate vein and successful catheter placement

    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)

    7 months

Study Arms (2)

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.

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.

Interventions

We applied black pepper essential oil to the participants in experimental group before the catheter insertion procedure

Essential oil application group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be evaluable their veins as 1, 2 and 3 according to vein assessment scale Must be able to communicate

You may not qualify if:

  • Clinical diagnosis of peripheral vascular disease Clinical diagnosis of any other chronic illness (except cancer)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yalova University

Yalova, 77200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

SpasmPatient Satisfaction

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Handan Eren, PhD

    University of Yalova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 15, 2021

Study Start

May 2, 2019

Primary Completion

October 9, 2019

Study Completion

January 1, 2020

Last Updated

March 16, 2021

Record last verified: 2021-03

Locations