Exploratory Trial on the Psychological and Physiological Evaluation, as well as the Manifestation of Awareness through Associating Scents with Visual Images, Induced by Smell the scent of the Test Product

UMIN ID: UMIN000052297

Registered date:26/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Adult female
• Date of first enrollment: 2023/09/26
• Target sample size: 22
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Smell the aroma by placing your nose close to a container filled with the test product.
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Outcome(s)

• Primary Outcome: Autonomic nervous system evaluation (pupil diameter measurement, skin temperature measurement) Central nervous system evaluation (cerebral blood flow measurement)
• Secondary Outcome: Psychological questionnaire (SCL30, POMS2, VAS)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 50years-old
• Gender: Female
• Exclude criteria: 1. Subjects who are continuously taking prescription medication as advised by a physician (over-the-counter medication is excluded). 2. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. 3. Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. 4. Subjects undergoing hormone replacement therapy. 5. Subjects who are experiencing menopausal symptoms (e.g., hot flashes, flushing, sweating). 6. Subjects who are sensitive to cold (including those who are aware of their sensitivity) 7. Subjects with dry eye syndrome. 8. Subjects with eye conditions such as exotropia, esotropia, or ptosis. 9. Subjects currently experiencing nasal congestion due to allergic rhinitis or similar conditions. 10. Subjects who have difficulty perceiving or judging scents. 11. Smokers or Subjects who have quit smoking within the last six months. 12. Subjects with a history or current diagnosis of mental illness. 13. Subjects who regularly consume large amounts of alcohol. 14. Subjects with injuries on their forehead or fingertips (first and second joints). 15. Subjects diagnosed with atopic dermatitis or exhibiting symptoms of skin disorders. 16. Subjects who feel unwell or intoxicated when smelling perfumes or fragrances. 17. Subjects who have been determined ineligible by principal investigator.

Related Information

• Primary Sponsor: Mandom Corporation
• Source(s) of Monetary Support: Mandom Corporation