Evaluation of Aromatherapy on Academic Stress ((EAS))

September 27, 2021 updated by: Atta Abbas Naqvi, Universiti Sains Malaysia

Evaluation of Aromatherapy on Academic Stress: A Randomized Placebo Controlled Clinical Trial

Stress affects the health and is prevalent among medicine and pharmacy students. A number of factors such as busy schedules, course load and lack of recreational time during semesters as well as exams, have been reported to be associated with stress. Study reports that the use of aroma oils especially those with relaxant properties can alleviate the level of stress. This study aims to investigate the effects of aroma oils in stress during exams in pharmacy students.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

Stress is a disorder that affects human feelings through disturbance in behavior, thinking and mood. The mood disturbances further leads to mental, physical and emotional problems which affects the learning as well as thinking capabilities of individuals.Work load i.e. preparing for exams along with acquisition of knowledge, skills and attitudes have been reported as more stressful to cope up with, during university life of medical students. Exam load is reported as a major stressor and a number of studies have reported a suffering of 30% medical students due to exam stress. whereas some studies have reported a high stress level in 80% of college students during exams. No significant difference is observed for gender with regard to level of stress during exams. Besides course loads, exams, quizzes and busy schedule, academic competition among students for higher grades also promotes stress. This academic competition in students may sometimes be unavoidable. Alternative treatment namely aromatherapy, hydrotherapy and homeopathy are employed to reduce stress.

Aromatherapy is one of the alternative treatments in which oils extracted from natural sources such as flowers, petals and bark of plants are used to enhance the physical and psychological conditions of individuals. Various naturally extracted aromatic essences are applied in order to balance cognitive functions and memory retention. The aromatic essences/oils used in aromatherapy such as lavender oil, rosemary oil, jasmine oil, peppermint oil etc. are believed to stimulate cognitive function and are used for purposes of pain relieving, mood enhancement. Among these essences, lavender oil has been applied predominantly in oral administration, aromatherapy as well as massage therapy in many clinical studies exhibiting positive outcomes. Lavender oil reduces stress and produce relaxation via limbic system, particularly the amygdala and hippocampus.

A comparative study in 36 volunteers showed a reduced stress level in group using lavender oil as aromatherapy as compared to placebo group. Another study at Hong Kong University revealed the fact that aromatherapy may be utilized as an effective tool in order to alleviate pain, reduce depression and level of stress in older adults. A study in Iran among students, showed reduction in test-related anxiety with the use of Polianthes tuberosa essential oils. Similar study in students of Florida Atlantic University observed the vital effects of aroma oils and recommended the use of rosemary and lavender oil during exam for reducing stress level. In addition, lavender oil as stress reducer and leading towards relaxation during exam stress has been reported. Lavender oil as a cream along with a foot-bath, may be used in pregnant as well as non-pregnant females even, in order to reduce stress and anxiety. Based on aforementioned results, lavender oil may be effectively used to reduce the level of stress, produced due to any factor. However, none of the studies have reported the use of lavender oil in pharmacy students particularly during exams.

This study is aimed to target Pharmacy students at Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia in order to evaluate the effect of aromatherapy i.e. lavender oil in stress among students during exams.

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 (Actual)

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.
49

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 Locations

  • Saudi Arabia
    • Eastern Province
      • Dammam, Eastern Province, Saudi Arabia, 31441
        • College of Clinical Pharmacy

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

18 years to 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • The study includes only male student of Pharmacy college at IAU.
  • Students from 2nd to 5th year are eligible for the study.
  • All the students who are willing to participate voluntarily and are in healthy state will be included in the study.

Exclusion Criteria:

  • Students from other colleges as well as female students are not included in the study.
  • Any student who have no consent to participate will be excluded from this study.
  • Students with a history of stress, anxiety and depression, with any serious chronic medical conditions, any known allergy to aromatherapy or lavender oil.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel 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.
Placebo Comparator: Group-I (Control group)
This group will be administered a placebo that is an odorless oil without any therapeutic effect)
Other: Placebo
an odorless oil without any therapeutic effect
Other Names:
  • An odorless oil without any therapeutic effect
Experimental: Group-II (Treated group)
This group will be administered lavender oil.
Drug: Lavender Oil
The oil used in this study will be lavender oil with a final concentration of 3% using almond oil (90%) as diluent. The oil after dilution and final preparation will be converted to proper clean vial in a fix amount (10 ml) and given to the students.
No Intervention: Group-III (Untreated group)
No intervention will be provided in this group.

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
Change from baseline perceived academic stress at day 7 and at day 14
Time Frame: Day 1 to day 7 till day 14
For investigating the level of stress during examination, a subjective perceived stress scale would be given to students to report perceived academic stress. The range of this scale is from 0 to 5 where a value of 0 indicate no academic stress and value of 5 indicate severe academic stress.
Day 1 to day 7 till day 14
Change in baseline mean Blood pressure at day 7 and at day 14
Time Frame: Day 1 to day 7 till day 14
For observing any change in mean blood pressure, a blood pressure monitor will be used to determine any variation in blood pressure in millimeters of mercury (mm of Hg). A total of three readings will be taken at baseline day 0, day 7 and day 14. The mean value obtained from three readings will be considered final for each time point.
Day 1 to day 7 till day 14
Change in baseline heart rate at day 7 and at day 14
Time Frame: Day 1 to day 7 till day 14
For observing any change in heart rate, a blood pressure monitor will be used to determine change in heart rate in beats per minute (BPM). A total of three readings will be taken at baseline, day 7 and day 14. The mean value obtained from three readings will be considered final for each time point.
Day 1 to day 7 till day 14
Change in baseline Stool consistency at day 7 and day 14
Time Frame: Day 1 to day 7 till day 14
Bristol stool chart (BST) to indicate the consistency and frequency of stools passed during this period. Bristol stool chart consists of 7 types of stools. It is a subjective assessment.
Day 1 to day 7 till day 14
Change in baseline headache at day 7 and day 14
Time Frame: Day 1 to day 7 till day 14
visual analog scale (VAS) for recording the intensity of headache experienced by students during this period. Visual Analogue Scale consist of a range of 1 to 5. (1 = normal and 5 = extreme). It is a subjective self reporting instrument.
Day 1 to day 7 till day 14

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.
Universiti Sains Malaysia

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.
  • Study Chair: Dr Mastour S Al Ghamdi, PhD, Dean, College of Clinical Pharmacy

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 (Actual)

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.
February 2, 2018

Primary Completion (Actual)

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.
April 1, 2018

Study Completion (Actual)

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.
April 5, 2018

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).
February 19, 2018

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.
March 7, 2018

First Posted (Actual)

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.
March 9, 2018

Study Record Updates

Last Update Posted (Actual)

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.
October 5, 2021

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 27, 2021

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, 2021

More Information

Terms related to this study

Keywords

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.
  • IAU-ATCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All data pertaining to the clinical trial will be made available after study completion.

IPD Sharing Time Frame

The data will be available after March 5, 2018.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

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.

Clinical Trials on Stress

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings