Effects of Different Aroma-therapies on Nursing Students.

September 16, 2024 updated by: Martha J.Greenberg, Pace University

Effects of Single and Combined Aromatherapy on Nursing Student Anxiety, Test Anxiety, Nausea or Queasiness, Exam Grades, GPA, and Perceived Stress

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will identify subjects test anxiety and poor sleep quality and reduction in anxiety prior to/ during performance assessments as a result of the anxiolytic properties of the lavender essential oil inhaler we will provide them with and potentially improvement in quality of sleep. Studies using lavender essential oil to reduce anxiety in college 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. The use of lavender also appears to help sleep without the adverse effects of commonly used drugs Further, 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Michele Lopez, PhD, RN
  • Phone Number: (914) 773-3063
  • Email: mlopez3@pace.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Placebo group
a sham unscented aromatherapy patch will be applied to subjects clothing, 4-6 inches below the neck on the thorax
Other: Aromatherapy
Aromatherapy and placebo patches will be used
Active Comparator: Combined Aromatherapy Group
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
Aromatherapy and placebo patches will be used
Active Comparator: Single Aromatherapy Lavendar Group
A single scent Lavander aromatherapy patch will be applied 4-6 inches below nose on front of thorax on subjects clothing
Other: Aromatherapy
Aromatherapy and placebo patches will be used

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: From date of enrollment to up to 52 weeks
Number of participants with anxiety
From date of enrollment to up to 52 weeks
Test anxiety
Time Frame: From date of enrollment to up to 52 weeks
Number of participants with test anxiety prior to examinations
From date of enrollment to up to 52 weeks
Perceived stress
Time Frame: From date of enrollment to up to 52 weeks
Number of participants who perceive stress before taking an examination
From date of enrollment to up to 52 weeks
nausea or queasiness
Time Frame: From date of enrollment to up to 52 weeks
Number of participants who have nausea and/or queasiness prior to examinations
From date of enrollment to up to 52 weeks
Exam grade
Time Frame: From date of enrollment to up to 52 weeks
Number of participants who take a specific course examination
From date of enrollment to up to 52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Grade point average (GPA)
Time Frame: From date of enrollment to up to 52 weeks
Numerical indicator of cumulative grade success in the nursing program.
From date of enrollment to up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pace University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martha J Greenberg, PhD, RN, Pace University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PaceU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

I had not really considered it

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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