NCT06603896

Brief Summary

The aim of this study is to investigate the use of lavender and citrus inhalation aromatherapy on anxiety, test anxiety and sleep quality in Pace University sophomore, junior and senior nursing majors. Anxiety, particularly test anxiety, is a ubiquitous problem among nursing students. Test anxiety is a type of state anxiety experienced as concern or fear before, during, or following a test or performance assessment. While some anxiety may enhance the performance of a student, test anxiety often negatively effects performance. Although test anxiety can be incapacitating to any student, in nursing students it can not only have a negative impact on learning, it is a major cause for under-achievement and prevents some students from reaching their academic potential since they are enrolled in a high-stakes program. Treatment for test anxiety includes counseling, desensitization therapy, relaxation therapies, and aromatherapy. Aromatherapy with its focus on the therapeutic use of plant oils has the ability to decrease anxiety in humans through the use of natural oils particularly Lavandula angustifolia (lavender) without the potential for adverse reactions or side effects of conventional anxiolytic drugs. Research on the efficacy of aromatherapy on test anxiety in college and nursing students shows mixed results. A variety of designs and essential oil scents, either mixed or single, were used with subjects, e.g., lavender, rosemary, peppermint, lemon and the vehicles used to administer the oils, e.g., room diffused inhalation, non-absorbent cloth infused lavender for the aromatherapy vary. However, studies using lavender essential oil to reduce anxiety in college students, nursing students, and patients, demonstrated that lavender overall acted as an effective anxiolytic in reducing the stress of test taking, especially with lower levels of anxiety. Thus lavender essential oil could benefit nursing students in reducing test anxiety, and has great potential in benefiting all students in test and anxiety reduction, provided the person is not allergic to the oil. There is support for the notion that aromatherapy is a safe intervention, in a systematic review on the anxiolytic effects of aromatherapy in people with anxiety symptoms, no participants reported experiencing any adverse effects., The use of lavender also appears to help sleep without the adverse effects of commonly used drugs. The anxiolytic effects of the oil might reduce unhealthy behaviors that students engage in, e.g. alcohol and drug use/overuse, to reduce stress and relax, and positively affect sleep. In a 2015-2016 study of Pace nursing students, the results showed improvement in sleep and test anxiety, although the sample was small.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.2 years

First QC Date

September 7, 2024

Last Update Submit

September 16, 2024

Conditions

Keywords

aromatherapynursingstudenttestanxietynauseaGPAstress

Outcome Measures

Primary Outcomes (5)

  • Anxiety

    Number of participants with anxiety

    From date of enrollment to up to 52 weeks

  • Test anxiety

    Number of participants with test anxiety prior to examinations

    From date of enrollment to up to 52 weeks

  • Perceived stress

    Number of participants who perceive stress before taking an examination

    From date of enrollment to up to 52 weeks

  • nausea or queasiness

    Number of participants who have nausea and/or queasiness prior to examinations

    From date of enrollment to up to 52 weeks

  • Exam grade

    Number of participants who take a specific course examination

    From date of enrollment to up to 52 weeks

Secondary Outcomes (1)

  • Grade point average (GPA)

    From date of enrollment to up to 52 weeks

Study Arms (3)

Placebo group

SHAM COMPARATOR

a sham unscented aromatherapy patch will be applied to subjects clothing, 4-6 inches below the neck on the thorax

Other: Aromatherapy

Combined Aromatherapy Group

ACTIVE COMPARATOR

A combined scents Citrus Lavendar infused aromatherapy patch will be applied to subjects clothing, 4-6 inches below the neck on the thorax

Other: Aromatherapy

Single Aromatherapy Lavendar Group

ACTIVE COMPARATOR

A single scent Lavander aromatherapy patch will be applied 4-6 inches below nose on front of thorax on subjects clothing

Other: Aromatherapy

Interventions

Aromatherapy and placebo patches will be used

Combined Aromatherapy GroupPlacebo groupSingle Aromatherapy Lavendar Group

Eligibility Criteria

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

You may qualify if:

  • nursing students
  • years of age or older
  • Male or Female
  • all ethnicities will be included

You may not qualify if:

  • cognitive impairments interring with reading, comprehending, following directions
  • unstable psychiatric impairments
  • chronic depression
  • severe anxiety disorders
  • asthma,
  • fragrance allergy
  • rhinitis
  • upper respiratory tract infection
  • lower respiratory tract infection
  • smell/odor impairments
  • allergies to plant-based essential oils
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Hashemi N, Nazari F, Faghih A, Forughi M. Effects of blended aromatherapy using lavender and damask rose oils on the test anxiety of nursing students. J Educ Health Promot. 2021 Sep 30;10:349. doi: 10.4103/jehp.jehp_88_21. eCollection 2021.

    PMID: 34761035BACKGROUND
  • Ozer Z, Teke N, Turan GB, Bahcecik AN. Effectiveness of lemon essential oil in reducing test anxiety in nursing students. Explore (NY). 2022 Sep-Oct;18(5):526-532. doi: 10.1016/j.explore.2022.02.003. Epub 2022 Feb 10.

    PMID: 35190270BACKGROUND
  • Kaur Khaira M, Raja Gopal RL, Mohamed Saini S, Md Isa Z. Interventional Strategies to Reduce Test Anxiety among Nursing Students: A Systematic Review. Int J Environ Res Public Health. 2023 Jan 10;20(2):1233. doi: 10.3390/ijerph20021233.

    PMID: 36673999BACKGROUND
  • Johnson CE. Effect of Inhaled Lemon Essential Oil on Cognitive Test Anxiety Among Nursing Students. Holist Nurs Pract. 2019 Mar/Apr;33(2):95-100. doi: 10.1097/HNP.0000000000000315.

    PMID: 30747778BACKGROUND

MeSH Terms

Conditions

NauseaAnxiety Disorders

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Martha J Greenberg, PhD, RN

    Pace University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martha J. Greenberg, PhD, RN

CONTACT

Michele Lopez, PhD, RN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 7, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

I had not really considered it