Evaluation of Aromatherapy on Academic Stress

NCT03460626 | Completed DMC

• 1 other identifier: IAU-ATCT
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Academic Underachievement Disorder

Keywords

stress; pharmacy students; Saudi Arabia

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Day 1 to day 7 till day 14

Study Arms (3)

Group-I (Control group)

PLACEBO COMPARATOR

This group will be administered a placebo that is an odorless oil without any therapeutic effect)

Other: Placebo

Group-II (Treated group)

EXPERIMENTAL

This group will be administered lavender oil.

Drug: Lavender Oil

Group-III (Untreated group)

NO INTERVENTION

No intervention will be provided in this group.

Interventions

Lavender Oil DRUG

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.

Group-II (Treated group)

Placebo OTHER

an odorless oil without any therapeutic effect

Also known as: An odorless oil without any therapeutic effect

Group-I (Control group)

Eligibility Criteria

• Age: 18 Years - 24 Years
• Gender Eligibility Details: This study was conducted only in the male pharmacy students.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

College of Clinical Pharmacy

Dammam, Eastern Province, 31441, Saudi Arabia

Location

MeSH Terms

Interventions

lavender oil

Study Officials

• Dr Mastour S Al Ghamdi, PhD

  Dean, College of Clinical Pharmacy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Group-I and Group-II will be blinded to the intervention while Group-III would not be administered an intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Model Details: 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)

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: March 9, 2018
• Study Start: February 2, 2018
• Primary Completion: April 1, 2018
• Study Completion: April 5, 2018
• Last Updated: October 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be available after March 5, 2018.

Locations

SA (1)