NCT05459025

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

July 12, 2022

Last Update Submit

July 12, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    10-15 minutes

Study Arms (2)

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.

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.

Behavioral: Yoga

Interventions

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.

Aromatherapy yoga
YogaBEHAVIORAL

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.

Yoga

Eligibility Criteria

Age18 Years - 21 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • We included female college students aged \> 18 years, who were able to understand the questionnaire.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asia Univeraity

Taichung, WuFeng, 41354, Taiwan

Location

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 12, 2022

First Posted

July 14, 2022

Study Start

March 1, 2021

Primary Completion

June 1, 2021

Study Completion

August 1, 2021

Last Updated

July 14, 2022

Record last verified: 2022-07

Locations