UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045123 |
|---|---|
| Receipt number | R000051547 |
| Scientific Title | Effects of Aromatherapy with Lindera umbellata Essential Oil on Emotions, Stress Changes, and Cognitive Functions of Elderly Patients in Need of Care |
| Date of disclosure of the study information | 2021/08/15 |
| Last modified on | 2021/08/11 14:12:18 |
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Basic information
Public title
Effects of Aromatherapy with Lindera umbellata Essential Oil on Emotions, Stress Changes, and Cognitive Functions of Elderly Patients in Need of Care
Acronym
Effects of Aromatherapy with Lindera umbellata Essential Oil on Emotions, Stress Changes, and Cognitive Functions of Elderly Patients in Need of Care
Scientific Title
Effects of Aromatherapy with Lindera umbellata Essential Oil on Emotions, Stress Changes, and Cognitive Functions of Elderly Patients in Need of Care
Scientific Title:Acronym
Effects of Aromatherapy with Lindera umbellata Essential Oil on Emotions, Stress Changes, and Cognitive Functions of Elderly Patients in Need of Care
Region
| Japan |
Condition
Condition
elderly people requiring nursing care
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The investigators conducted a study in 2019 on the effects of aromatherapy using daisy chromosome aromatic essential oil on the emotions stress changes and cognitive function of elderly people in need of care and found that application of daisy chromosome aromatic oil diluted to 1% to the shoulder area tended to reduce stress and maintain cognitive function in elderly people in need of care. It was also found that recreational activities during the aromatherapy intervention period increased the time of relaxation in terms of emotions compared to the control period (kikukawa et.al, 2021).Therefore, in this study, we will focus on chromophyllum, which contains more active ingredients, about 30percent linalool and 4percent limonene, than daisy, which showed certain effects, and investigate the effects of chromophyllum aromatherapy on the emotions, stress changes, and cognitive functions of the elderly requiring care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of stress reduction due to changes in salivary cortisol levels at 2 and 4 weeks after intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Aromatherapy using cromophyllum essential oil
Interventions/Control_2
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) With regard to the criteria for the level of independence, regardless of the level of care, those who are ranked from I to IIIb in the level of independence in daily life for elderly people with dementia, and those who are ranked as independent or semi-bedridden in the level of independence in daily life for elderly people with disabilities.
(2) Those who are not taking medication such as sleeping pills or tranquilizers and can participate in recreational activities in the facility.
3) Those who have passed the patch test for chromosomal aromatic oil.
3) Those who have passed a patch test for chromosomal aroma oil. 4) Those who have obtained written consent.
Key exclusion criteria
(1) With regard to the criteria for the level of independence, those classified as Rank IV (interferes with daily life and requires constant nursing care) or Rank M (has significant mental symptoms or problematic behavior and requires specialized medical care) in the level of independence in daily life of elderly people with dementia, and those classified as Rank C in the level of independence in daily life of elderly people with disabilities who are bedridden.
Those who are taking medication such as sleeping pills or tranquilizers.
(3) Those who have allergy symptoms (those who failed the patch test of chromodiaroma oil)
3) Those who have allergic symptoms (those who failed the patch test of Cromer aromatic oil). 4) Those who are not allowed to participate by 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,Graduate School of Landscape Design and Management, University of Hyogo
Division name
Cultural Properties Division
Zip code
669-3464
Address
1155 Isou, Hikami-cho, Tamba City
TEL
0795825912
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, Aguta, Kashiwabara-cho, Tamba City
TEL
0795-73-1365
Homepage URL
ag19041@s.okadai.jp
Sponsor or person
Institute
Board of Education of Tamba city
Institute
Department
Personal name
Funding Source
Organization
Aroma Environment Association of Japan
Organization
Division
Category of Funding Organization
Profit organization
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
1155 Isou, Hikami-cho, Tamba City
Tel
0795825912
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 15 | 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
| 2021 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2021 | 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
| 2021 | Year | 08 | Month | 11 | Day |
Last modified on
| 2021 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051547
| Research Plan | |
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