Tokyo, May 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061571) titled 'The Sedative Effects of Lavender on Social Anxiety and an Examination of Their Psychological and Neuroscientific Mechanisms' on May 15.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Placebo
Primary Sponsor:
Institute - Institute of Development, Aging and Cancer, Tohoku University
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To clarify the calming effects of lavender aroma intervention on social anticipatory anxiety that occurs during the preparation phase of social situations, using subjective state anxiety as the primary outcome measure.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Lavender flavor
Interventions/Control_2 - Odorless
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Female
Key inclusion criteria - -Native Japanese speakers
-Individuals who do not experience strong aversion to the scent of lavender
-Right-handed individuals
-Individuals who have never been diagnosed by a doctor with a smell disorder
-Individuals with no fragrance allergies
-Non-smokers
Key exclusion criteria - -Individuals who have been diagnosed by a physician with a disorder of the sense of smell
-Individuals with chronic rhinitis or other conditions that may affect the sense of smell
-Individuals who are pregnant or breastfeeding
-Individuals with a history of severe mental illness or currently undergoing treatment for such conditions
-Individuals with a history of severe neurological disorders (e.g., epilepsy, severe traumatic brain injury, central nervous system disorders) or currently suffering from progressive neurological diseases
-Individuals with severe respiratory diseases or a history of asthma attacks, for whom exposure to fragrances poses a health risk
-Currently undergoing psychotherapy;
-Unable to provide informed consent;
-History of severe allergic reactions to fragrances (e.g., anaphylaxis) or significant fragrance intolerance;
-Physical or cognitive limitations that would interfere with study participation;
-Any other individuals whom the principal investigator determines would compromise the safety or validity of the data in this study.
Target Size - 34
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 01 Day
Anticipated trial start date - 2026 Year 05 Month 31 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070426
Disclaimer: Curated by HT Syndication.