Stress(EAS)NCT03460626
Evaluation of Aromatherapy on Academic Stress
A study testing Lavender Oil in people with Stress and Academic Underachievement Disorder, run by Universiti Sains Malaysia at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Academic Underachievement Disorder
- What is being tested?
- Lavender Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 2 Feb 2018to 5 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
College of Clinical Pharmacy
Dammam, Eastern Province, 31441
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress, Academic Underachievement Disorder
- Being tested
- Lavender Oil, Placebo
- Keywords
- stress, pharmacy students, Saudi Arabia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender OilDrug
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.
PlaceboOther
Also called An odorless oil without any therapeutic effect
an odorless oil without any therapeutic effect
| Study group | Role | What they receive |
|---|---|---|
| Group-I (Control group) | Placebo comparator | This group will be administered a placebo that is an odorless oil without any therapeutic effect) Receives: Other: Placebo |
| Group-II (Treated group) | Experimental | This group will be administered lavender oil. Receives: Drug: Lavender Oil |
| Group-III (Untreated group) | No intervention | No intervention will be provided in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline perceived academic stress at day 7 and at 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.
Measured: Day 1 to day 7 till day 14
Change in baseline mean Blood pressure at day 7 and at 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.
Measured: Day 1 to day 7 till day 14
Change in baseline heart rate at day 7 and at 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.
Measured: Day 1 to day 7 till day 14
Change in baseline Stool consistency at day 7 and 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.
Measured: Day 1 to day 7 till day 14
Change in baseline headache at day 7 and 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.
Measured: Day 1 to day 7 till day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start2 Feb 2018
- Primary completion1 Apr 2018
- Study completion5 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atta Abbas Naqvi, Imam Abdulrahman Bin Faisal University
- Investigators
- Dr Mastour S Al Ghamdi, PhD, Study chair, Dean, College of Clinical Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460626
- Sponsor's protocol ID
- IAU-ATCT
- Acronym
- (EAS)
- Status last verified
- Sep 2021
- First submitted
- 19 Feb 2018
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data pertaining to the clinical trial will be made available after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Aromatherapy on Academic Stress: A Randomized Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03460626
- Acronym / sponsor ID
- (EAS) / IAU-ATCT
- Conditions
- Stress, Academic Underachievement Disorder
- Keywords
- stress, pharmacy students, Saudi Arabia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 5 Apr 2018 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| Group-I (Control group) | Placebo comparator | Other: PlaceboThis group will be administered a placebo that is an odorless oil without any therapeutic effect) |
| Group-II (Treated group) | Experimental | Drug: Lavender OilThis group will be administered lavender oil. |
| Group-III (Untreated group) | No intervention | –No intervention will be provided in this group. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lavender OilThe 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. | Drug | Group-II (Treated group) |
| PlaceboAlso: An odorless oil without any therapeutic effectan odorless oil without any therapeutic effect | Other | Group-I (Control group) |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Individual participant dataSharing planned: Yes. All data pertaining to the clinical trial will be made available after study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Mastour S Al Ghamdi, PhD study chair
Dean, College of Clinical Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender Oil in people with Stress and Academic Underachievement Disorder, run by Universiti Sains Malaysia at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline perceived academic stress at day 7 and at day 14 (time frame: Day 1 to day 7 till day 14). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.