UMIN ID: UMIN000053914
Registered date:01/04/2024
Evaluating the relaxation effects of Shikuwasa (Citrus depressa Hayata) essential oil inhalation in young female adults: study protocol for a randomised controlled trial
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Young female adults |
| Date of first enrollment | 2024/04/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | inhalation of Shikuwasa essential oil Inhalation of odour-free air (non-active control condition) |
Outcome(s)
| Primary Outcome | 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 Outcome | 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 |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | 39years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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. |
Related Information
| Primary Sponsor | University of Miyazaki |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ogawa & Co., Ltd |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yasuji Arimura |
| Address | Kihara5200, Kiyotake, Miyazaki889-1692, Japan Japan 889-1692 |
| Telephone | 0985-85-9577 |
| yasuji_arimura@med.miyazaki-u.ac.jp | |
| Affiliation | University of Miyazaki Department of Health Care Research, University of Miyazaki (Kiyotake Branch) |
| scientific contact | |
| Name | Yasuji Arimura |
| Address | Kihara5200, Kiyotake, Miyazaki889-1692, Japan Japan |
| Telephone | 0985-85-9577 |
| yasuji_arimura@med.miyazaki-u.ac.jp | |
| Affiliation | University of Miyazaki Department of Health Care Research, Organization for Promotion of Research and Industry-Academic Regional Collaboration, University of Miyazaki (Kiyotake Branch) |