Female College StudentsNCT05459025
Effectiveness of Aromatherapy Yoga
A study testing Aromatherapy yoga and Yoga in people with Female College Students, run by Yang Shang-Yu at 1 site in Taiwan.
Trial summary
College students, particularly female students, often suffer from severe stress and poor sleep. Aromatherapy yoga has become a popular exercise in recent years and may help reduce stress and improve sleep quality, although empirical evidence is limited. Read more about this study
- Who is it for?
- Ages 18 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female College Students
- What is being tested?
- Aromatherapy yoga and Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2021to 1 Aug 2021
- 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 21 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- We included female college students aged > 18 years, who were able to understand the questionnaire.
Who cannot join
- We excluded male students, those with a history of respiratory disease, asthma, or allergy to flowers, plants, or essential oils, those who worked at night, and those with a history of mental diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Aromatherapy Yoga in Stress Reduction and Sleep Quality Improvement Among Female College Students: A Quasi-Experimental Study
College students, particularly female students, often suffer from severe stress and poor sleep. Aromatherapy yoga has become a popular exercise in recent years and may help reduce stress and improve sleep quality, although empirical evidence is limited. We investigated the effective-ness of aromatherapy yoga intervention in reducing stress and improving sleep quality among female college students. Eighty-nine participants (44 in the experimental group [aromatherapy yoga] and 45 in the control group [yoga]), with an average age of 19.88 ± 1.13 years, were en-rolled in this quasi-experimental study. Interventions were performed in the respective groups once a week for 12 weeks, for 90 minutes each time. The Wilcoxon signed-rank test and Mann-Whitney U test (including effect size) were used to test the differences in stress reduction and sleep quality before and after the intervention.
- Conditions
- Female College Students
- Being tested
- Aromatherapy yoga, Yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy yogaBehavioural
The research assistant diluted the Lavandula angustifolia essential oil with distilled water (1:75) 10 min before the yoga session started. The solution was then atomized by three aroma diffusers, placed in the front, middle, and back of the classroom. The distance from each participant was less than 10 m to ensure that the aroma was absorbed com-pletely. The yoga course for the aromatherapy yoga group was the same as that of the yoga only group. The yoga group only took a yoga course, without aromatherapy.
YogaBehavioural
The design of the yoga lessons was based on a past study and a professional yoga instruction book. Yoga lessons were led by certified yoga tutors.
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy yoga | Experimental | Each intervention session lasted 90 min, between 6 p.m. and 7:30 p.m. The course was held in a yoga classroom once a week, in an area of 30 m × 35 m. Furthermore, the total intervention period lasted for 12 weeks. Receives: Behavioral: Aromatherapy yoga |
| Yoga | Active comparator | Each intervention session lasted 90 min, between 6 p.m. and 7:30 p.m. The course was held in a yoga classroom once a week, in an area of 30 m × 35 m. Furthermore, the total intervention period lasted for 12 weeks. Receives: Behavioral: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale 14 (PSS-14)
PSS-14 is the scale that is most widely used for measuring the degree to which situations in one's life are appraised as being stressful.
Measured: 10-15 minutes
Pittsburgh Sleep Quality Index (PSQI)
The PSQI developed by Buysse et al. [45], which evaluates sleep quality of the participants in the past month.
Measured: 10-15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Mar 2021
- Primary completion1 Jun 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female College StudentsStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yang Shang-Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yang Shang-Yu, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459025
- Sponsor's protocol ID
- HZAUHU-2021-0001
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2022
- Last updated
- 14 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Aromatherapy Yoga in Stress Reduction and Sleep Quality Improvement Among Female College Students: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT05459025
- Acronym / sponsor ID
- HZAUHU-2021-0001
- Conditions
- Female College Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Yang Shang-YuUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 14 Jul 2022 (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.
College students, particularly female students, often suffer from severe stress and poor sleep. Aromatherapy yoga has become a popular exercise in recent years and may help reduce stress and improve sleep quality, although empirical evidence is limited. We investigated the effective-ness of aromatherapy yoga intervention in reducing stress and improving sleep quality among female college students. Eighty-nine participants (44 in the experimental group [aromatherapy yoga] and 45 in the control group [yoga]), with an average age of 19.88 ± 1.13 years, were en-rolled in this quasi-experimental study. Interventions were performed in the respective groups once a week for 12 weeks, for 90 minutes each time. The Wilcoxon signed-rank test and Mann-Whitney U test (including effect size) were used to test the differences in stress reduction and sleep quality before and after the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy yoga | Experimental | Behavioral: Aromatherapy yogaEach intervention session lasted 90 min, between 6 p.m. and 7:30 p.m. The course was held in a yoga classroom once a week, in an area of 30 m × 35 m. Furthermore, the total intervention period lasted for 12 weeks. |
| Yoga | Active comparator | Behavioral: YogaEach intervention session lasted 90 min, between 6 p.m. and 7:30 p.m. The course was held in a yoga classroom once a week, in an area of 30 m × 35 m. Furthermore, the total intervention period lasted for 12 weeks. |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- We included female college students aged > 18 years, who were able to understand the questionnaire.
Key exclusion criteria (1 listed)
- We excluded male students, those with a history of respiratory disease, asthma, or allergy to flowers, plants, or essential oils, those who worked at night, and those with a history of mental diseases.
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 |
|---|---|---|
| Aromatherapy yogaThe research assistant diluted the Lavandula angustifolia essential oil with distilled water (1:75) 10 min before the yoga session started. The solution was then atomized by three aroma diffusers, placed in the front, middle, and back of the classroom. The distance from each participant was less than 10 m to ensure that the aroma was absorbed com-pletely. The yoga course for the aromatherapy yoga group was the same as that of the yoga only group. The yoga group only took a yoga course, without aromatherapy. | Behavioural | Aromatherapy yoga |
| YogaThe design of the yoga lessons was based on a past study and a professional yoga instruction book. Yoga lessons were led by certified yoga tutors. | Behavioural | Yoga |
Primary outcome
Perceived Stress Scale 14 (PSS-14)
Time frame: 10-15 minutes
PSS-14 is the scale that is most widely used for measuring the degree to which situations in one's life are appraised as being stressful.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 10-15 minutes
The PSQI developed by Buysse et al. [45], which evaluates sleep quality of the participants in the past month.
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 14 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy yoga and Yoga in people with Female College Students, run by Yang Shang-Yu at 1 site in Taiwan.
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 1 inclusion and 1 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 14 Jul 2022. 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 Taiwan. 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. 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?
Perceived Stress Scale 14 (PSS-14) (time frame: 10-15 minutes). The study lists 2 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 14 Jul 2022.