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Evaluating the relaxation effects of Shikuwasa (Citrus depressa Hayata) essential oil inhalation in young female adults: study protocol for a randomised controlled trial

Evaluating the relaxation effects of Shikuwasa (Citrus depressa Hayata) essential oil inhalation in young female adults: study protocol for a randomised controlled trial - Clinical trial to investigate the relaxation effects of Shikuwasa (Citrus depressa Hayata) essential oil inhalation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000053914
Enrollment
40
Registered
2024-04-01
Start date
2024-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Young female adults

Interventions

inhalation of Shikuwasa essential oil Inhalation of odour-free air (non-active control condition)

Sponsors

University of Miyazaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Female aged 18-39 years at the time of obtaining written informed consent. 2.Not being averse to the smell of citrus fruits, including Shikuwasa. 3.Expressing a willingness to participate in the study and providing voluntary consent by signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Having a history of or currently suffering from clinically problematic respiratory, gastrointestinal, hepatobiliary, haematological, renal, endocrine, cardiovascular, dermatological, or mental disorders. 2.Having a history of serious trauma or surgery within 12 weeks prior to the study. 3.Being sensitive to cold even in summer. 4.Unable to detect odours. 5.Having a history of or suspected allergy to foods (especially citrus fruits) or drugs requiring some kind of medical treatment. 6.Regularly taking psychotropic drugs (e.g. antidepressants, anxiolytics, or hypnotics) 7.Heavy smoker (21 or more cigarettes per day), heavy drinker (regularly drinking more than 60g pure alcohol per day), or having or suspected to have alcohol/substance misuse problems. 8.Regularly taking medicines, eating foods for specified health use, foods with function claims, or health food products that may affect the study results. 9.Being or possibly being pregnant or breastfeeding. 10.Have participated in other clinical trials within 4 weeks prior to the study. 11.Identifications of additional reasons, as deemed by study investigators, rendering the participant unsuitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
The tense arousal subscale scores of the Japanese version of the University of Wales Institute of Science and Technology Mood Adjective Checklist [JUMACL] after two minutes of inhalation of Shikuwasa essential oil fragrance or odour-free air.

Secondary

MeasureTime frame
1. The changes of miosis rate (autonomic nervous activity) before and after inhalation of Shikuwasa essential oil fragrance or odour-free air for 2 minutes. 2. The changes in peripheral skin temperature (autonomic nervous activity) before and after inhalation of Shikuwasa essential oil fragrance or odour-free air for 2 minutes. 3. The changes in cerebral blood flow (central nervous activity) before and after inhalation of Shikuwasa essential oil fragrance or odour-free air for 2 minutes. 4. Visual Analogue Scale (VAS) evaluation of preference and impression regarding Shikuwasa essential oil inhalation or odour-free air inhalation. 5. Adverse events

Countries

Japan

Contacts

Public ContactYasuji Arimura

University of Miyazaki Department of Health Care Research, University of Miyazaki (Kiyotake Branch)

yasuji_arimura@med.miyazaki-u.ac.jp0985-85-9577

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026