UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041961 |
|---|---|
| Receipt number | R000047893 |
| Scientific Title | Effects of aromatherapy using essential oil of Himekuromoji on emotions, stress changes and cognitive function in the elderly requiring long-term care |
| Date of disclosure of the study information | 2020/10/10 |
| Last modified on | 2021/06/04 17:03:59 |
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Basic information
Public title
Effects of aromatherapy using essential oil of Himekuromoji on emotions, stress changes and cognitive function in the elderly requiring long-term care
Acronym
Effect of Himekuromoji aroma on cognitive function, etc.
Scientific Title
Effects of aromatherapy using essential oil of Himekuromoji on emotions, stress changes and cognitive function in the elderly requiring long-term care
Scientific Title:Acronym
Effect of Himekuromoji aroma on cognitive function, etc.
Region
| Japan |
Condition
Condition
no special instruction
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we evaluate the effects of chromodiaroma oil on stress reduction and cognitive function and emotions in elderly people requiring long-term care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Reduction rate of stress due to changes in salivary cortisol concentration
Key secondary outcomes
Emotional quantification, vitals (pulse, blood pressure), cognitive function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Intervention 4 times in 2 weeks. For the first two weeks, placebo oil will be used to measure salivary cortisol, emotional changes, blood pressure, and pulse before and after about 30 minutes of recreational activity. For the next 2 weeks, intervention with aroma oil will be performed as an intervention period.
Interventions/Control_2
Perform basic attribute studies and cognitive function tests before and after the intervention.
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
| 70 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Those who can participate in recreational activities in the facility without taking sleeping pills or tranquilizers
2.Those who have passed the patch test of Himekuromoji aroma oil
3.Those who have obtained written consent
Key exclusion criteria
1.Those who are taking sleeping pills or tranquilizers
2.Those who have allergic symptoms (those who failed the patch test of chromodiaroma oil)
3.Those who are not allowed to participate at the discretion of the facility
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | KIKUKAWA |
| Middle name | |
| Last name | HIROYUKI |
Organization
Board of Education of Tamba city
Division name
Cultural Properties Division
Zip code
669-3198
Address
1110 Tanigawa, Sannancho, Tamba City, Hyogo
TEL
0795-70-0810
ag19041@s.okadai.jp
Public contact
Name of contact person
| 1st name | KUGE |
| Middle name | |
| Last name | MATSUYO |
Organization
Day service Sumire
Division name
Long-term care
Zip code
669-3314
Address
192-2 Ageta, Kaibara-cho, Tamba-shi, Hyogo
TEL
0795-73-1365
Homepage URL
sumire192_2@aql.bbiq.jp
Sponsor or person
Institute
Board of Education of Tamba city
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Board of Education of Tamba city
Address
1110 Tanigawa, Sannancho, Tamba City, Hyogo
Tel
0795-70-0810
ag19041@s.okadai.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
デイサービス すみれ
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
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
| 2020 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 01 | Day |
Last modified on
| 2021 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047893
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
