Clinical trial NCT03460626: Evaluation of Aromatherapy on Academic Stress
Official title: Evaluation of Aromatherapy on Academic Stress: A Randomized Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Academic Underachievement Disorder
Keywords: stress
pharmacy students
Saudi Arabia
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 49
Sex: MALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The students will be divided into three groups randomly as Group-I (Control group: treated with a placebo that is an odorless oil without any therapeutic effect), Group-II (Treated group: administered with lavender oil) and Group-III (Untreated group)
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline perceived academic stress at day 7 and at day 14
timeFrame: Day 1 to day 7 till day 14
measure: Change in baseline mean Blood pressure at day 7 and at day 14
timeFrame: Day 1 to day 7 till day 14
measure: Change in baseline heart rate at day 7 and at day 14
timeFrame: Day 1 to day 7 till day 14
measure: Change in baseline Stool consistency at day 7 and day 14
timeFrame: Day 1 to day 7 till day 14
measure: Change in baseline headache at day 7 and day 14
timeFrame: Day 1 to day 7 till day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: College of Clinical Pharmacy
state: Eastern Province
Study officials:
affiliation: Dean, College of Clinical Pharmacy
name: Dr Mastour S Al Ghamdi, PhD
role: STUDY_CHAIR
References: