UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035051 |
|---|---|
| Receipt number | R000039962 |
| Scientific Title | Does aromatherapy during sleep using aromatized patch reduce physiological and psychological stress? |
| Date of disclosure of the study information | 2018/11/28 |
| Last modified on | 2022/06/03 17:00:24 |
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Basic information
Public title
Does aromatherapy during sleep using aromatized patch reduce physiological and psychological stress?
Acronym
Does aromatherapy during sleep using aromatized patch reduce physiological and psychological stress?
Scientific Title
Does aromatherapy during sleep using aromatized patch reduce physiological and psychological stress?
Scientific Title:Acronym
Does aromatherapy during sleep using aromatized patch reduce physiological and psychological stress?
Region
| Japan |
Condition
Condition
Healty adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate whether aromatherapy during sleep using aromatized patch can reduce physiological and psychological stress
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary cortisol after 1-nignt and 7-night intervention
Key secondary outcomes
Salivary amylase, Profile of Mood States 2nd Edition (POMS 2), OSA sleep inventory MA version and pulse rate right after getting up after 1-nignt and 7-night intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intervention group: Put an lavender-aromatized patch on nightwear and sleep over 7 nights
Interventions/Control_2
Control group: Put a fragrance-free patch on nightwear and sleep over 7 nights
Interventions/Control_3
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adult
Key exclusion criteria
person who do aromatherapy routinely
smoker
women who are or may be pregnant
nursing mother
person who work the night shift
person who are receiving some medical treatment at present
person who take some sleeping drug
person who have allergies to lavender or orange
person who have allergic reaction or feeling of unwellness to aromatherapy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiko |
| Middle name | |
| Last name | Ogawa |
Organization
Teikyo University
Division name
Department of Sport and Medical Science, Faculty of Medical Technology
Zip code
192-0395
Address
359 Otsuka, Hachioji-shi, Tokyo, 192-0395 Japan
TEL
+81-42-690-2769
yogawa@main.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiko |
| Middle name | |
| Last name | Ogawa |
Organization
Teikyo University
Division name
Department of Sport and Medical Science, Faculty of Medical Technology
Zip code
192-0395
Address
359 Otsuka, Hachioji-shi, Tokyo, 192-0395 Japan
TEL
+81-42-690-2769
Homepage URL
yogawa@main.teikyo-u.ac.jp
Sponsor or person
Institute
Department of Sport and Medical Science, Faculty of Medical Technology, Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Teikyo 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
The Ethics Committee of the Teikyo University
Address
2-11-1 Kaga, Itabashi-ku, Tokyo
Tel
+81-3-3964-7256
turb-office@teikyo-u.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
| 2018 | Year | 11 | Month | 28 | 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
24
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
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 28 | Day |
Last modified on
| 2022 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039962
