NCT06843837

Brief Summary

This randomized controlled study examined the effect of sweet orange essential oil aromatherapy on reducing anxiety experienced by nursing students during the IV cannulation process. First-year nursing students from a university in eastern Turkey participated in the study. According to the sample size determined by G\*Power analysis, 100 students were randomized, and the study was completed with 47 students in the experimental group and 48 students in the control group. All students were taught IV cannulation skills theoretically and practically. Subsequently, students in the experimental group performed IV cannulation on real patients after receiving aromatherapy. Data were collected using a Personal Information Form, a Pulse Monitoring Form, and the State-Trait Anxiety Inventory (STAI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

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

September 2, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 19, 2025

Last Update Submit

February 27, 2025

Conditions

Keywords

Sweet orange aromatherapyNursing studentsIV cannulation skillAnxietyHeart rate

Outcome Measures

Primary Outcomes (1)

  • The State-Trait Anxiety Inventory (STAI)

    developed by Spielberger and colleagues in 1970, was adapted into Turkish by Öner and LeCompte. This four-point Likert scale consists of 20 short statements, 10 of which are reverse-coded. In the scale, the total score from the straightforward statements is subtracted from the total score of the reverse-coded statements, and a fixed number, 50, is added to the result. The scores obtained through this method range from 20 to 80, with scores between 20-39 indicating low, 40-59 indicating moderate, and 60-79 indicating high levels of anxiety. An increase in the score indicates a rise in the individual's anxiety level. The reliability coefficients of the scale range from 0.94 to 0.96 (Spielberger et al., 1970; Öner and LeCompte, 1998).

    3 month

Study Arms (2)

Intervention

EXPERIMENTAL

In this study, sweet orange essential oil was applied to reduce anxiety levels and physiological responses of nursing students during IV cannulation skill practice. The study data were collected in the intravenous (IV) access rooms of Fırat University Medical Center Hospital's outpatient clinic. There are two IV access rooms on the outpatient clinic floor, one of which was randomly assigned to the control group and the other to the experimental group. After administering pre-tests (Participant Information Form, Pulse Monitoring Form, and State-Trait Anxiety Inventory \[STAI\]), students were instructed to perform IV cannulation on the assigned patient. A cotton ball infused with three drops of sweet orange essential oil was held 4 to 5 cm away from the student's nose, and they were instructed to breathe slowly for five minutes. After this, the students were asked to perform IV cannulation on the patient.

Other: Sweet orange essential oil aromatherapy

control

NO INTERVENTION

Interventions

The sweet orange essential oil used in the study was prepared by the Food Engineering Department of Fırat University. To obtain the essential oil used for aromatherapy in this study, the peels of Citrus sinensis sweet oranges were utilized. The orange peels were cut into small pieces of approximately 3-5 mm in size, placed into a boiling flask, and distilled water was added. Based on the analysis results, the percentage composition of the total essential oil fatty acids was determined. The chemical composition analysis revealed that D-limonene was the major component, comprising 90% of the total oil. The oil is 100% pure essential oil, containing up to 90% D-limonene, along with citral and linalool. A cotton ball infused with three drops of sweet orange essential oil was held 4 to 5 cm away from the student's nose, and they were instructed to breathe slowly for five minutes. After this, the students were asked to perform IV cannulation on the patient.

Also known as: Sweet orange aromatherapy
Intervention

Eligibility Criteria

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

You may qualify if:

  • Being actively enrolled in school, not having performed an IV cannulation before, taking the Basic Principles and Fundamentals in Nursing I course, and not having any health issues that would prevent inhaling sweet orange oil.

You may not qualify if:

  • Not volunteering to participate in the study, not being actively enrolled in school, and having any health issues that would prevent inhaling sweet orange oil.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu university

Malatya, 44280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized controlled experimental model
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 19, 2025

First Posted

February 25, 2025

Study Start

September 2, 2024

Primary Completion

November 1, 2024

Study Completion

February 1, 2025

Last Updated

March 3, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Participants' data were collected for research purposes only according to the ethical principle of confidentiality and protection. Therefore, it cannot be shared.

Locations