Tokyo, March 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061098) titled 'Effects of heated eye mask use and the presence or absence of aroma on stress indicators and psychological state' on March 30.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Placebo
Primary Sponsor:
Institute - Hoshi University
Condition:
Condition - healthy adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the effects of using a hot eye mask and the presence or absence of fragrance on stress indicators and psychological state.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intervention 1: Participants will use a heated eye mask without aroma at bedtime.
Interventions/Control_2 - Intervention 2: Participants will use a heated eye mask with aroma at bedtime.
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Those who have received sufficient explanation about the purpose and contents of this research, have the ability to consent, volunteered voluntarily after fully understanding, and agreed to participate in writing.
Key exclusion criteria - Exclusion criteria for study participation are as follows:
1)Individuals who decline to participate of their own will
2)Those who cannot distinguish scents
3)Those who have had an allergic reaction in the patch test at the time of study registration
Target Size - 36
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 15 Day
Date of IRB - 2026 Year 03 Month 19 Day
Anticipated trial start date - 2026 Year 05 Month 11 Day
Last follow-up date - 2026 Year 11 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069250
Disclaimer: Curated by HT Syndication.
