UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061098 |
|---|---|
| Receipt number | R000069250 |
| Scientific Title | Effects of using a chamomile essential oil hot eye mask on psychological state and sleep quality: A crossover controlled trial |
| Date of disclosure of the study information | 2026/03/30 |
| Last modified on | 2026/03/29 17:39:55 |
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Basic information
Public title
Effects of heated eye mask use and the presence or absence of aroma on stress indicators and psychological state
Acronym
Effects of heated eye mask use and the presence or absence of aroma on stress indicators and psychological state
Scientific Title
Effects of using a chamomile essential oil hot eye mask on psychological state and sleep quality: A crossover controlled trial
Scientific Title:Acronym
Effects of using a chamomile essential oil hot eye mask on psychological state and sleep quality: A crossover controlled trial
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Changes in stress levels will be assessed using the DASS-21 (Depression Anxiety Stress Scales-21).
Key secondary outcomes
1) The effects of hot eye mask use on depression and anxiety will be evaluated using the DASS-21.
2) Salivary amylase activity will be measured as a physiological indicator of psychological and physical stress, and short-term changes (after the first day of use) and long-term changes (after 6 consecutive days of use) will be evaluated.
3) The effects of hot eye mask use on subjective well-being will be evaluated using the SHS, assessing short-term changes (after the first day of use) and long-term changes (after 6 consecutive days of use).
4) Using the OSA-MA, short-term (the morning after the first use) and long-term (the morning after 6 consecutive days) changes will be assessed to evaluate effects on sleep upon awakening and subjective sleep quality.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
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.
Interventions/Control_3
Control condition: Participants will not use a heated eye mask at bedtime.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 28 | 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 sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Division of Applied Pharmaceutical Education and Research
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
n-wakui@hoshi.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Practical Education and Research Division
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
Homepage URL
n-wakui@hoshi.ac.jp
Sponsor or person
Institute
Hoshi University
Institute
Department
Personal name
Funding Source
Organization
Hoshi University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hoshi University
Address
142-8501, 2-4-41 Ebara, Shinagawa-ku, Tokyo
Tel
03-3786-1011
y-hashiguchi@hoshi.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 29 | Day |
Last modified on
| 2026 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069250
