UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061579 |
|---|---|
| Receipt number | R000070452 |
| Scientific Title | Evaluation of the Effects of Aromatherapy on Elderly Residents in Care Facilities. |
| Date of disclosure of the study information | 2026/05/14 |
| Last modified on | 2026/05/14 20:22:35 |
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Basic information
Public title
Evaluation of the Effects of Aromatherapy on Elderly Residents in Care Facilities.
Acronym
Evaluation of the Effects of Aromatherapy on Elderly Residents in Care Facilities.
Scientific Title
Evaluation of the Effects of Aromatherapy on Elderly Residents in Care Facilities.
Scientific Title:Acronym
Evaluation of the Effects of Aromatherapy on Elderly Residents in Care Facilities.
Region
| Japan |
Condition
Condition
We will conduct a comprehensive evaluation of the sleep-improving effects of hand massages using lavender essential oil by combining objective assessment metrics with physiological indicators.
Classification by specialty
| Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will verify the sleep-improving effects of hand massage using lavender essential oil by measuring salivary oxytocin levels over time.
Basic objectives2
Others
Basic objectives -Others
We will verify the sleep-improving effects of hand massage using lavender essential oil through continuous sleep monitoring using objective evaluation metrics.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in salivary oxytocin concentration
Key secondary outcomes
Sleep Patterns Measured by a Sensor Mat-Type Sleep Monitor (Sleep SCAN)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
1.Adjust to each participant's sleep schedule. The intervention is conducted at the time each night when the participant lies down in bed to fall asleep. The aromatherapy oil used for the hand massage consists of a 1% dilution of lavender essential oil (manufactured by Seikatsunoki,sourced from France) mixed with clear jojoba oil (manufactured by Seikatsunoki).
2.Massage: Perform light stroking for 5 minutes per hand, covering the area from the palm to the elbow joint, for a total of 10 minutes per person.
3. Frequency and Duration of Intervention: Massage is performed three times a week, every other day (e.g., Mon-Wed-Fri or Tue-Thu-Sat),for two consecutive weeks, with a trained researcher consistently performing the treatment.
Interventions/Control_2
In addition to measuring sleep patterns using the objective sleep indicator Sensor Mat Sleep Monitor (Minori SCAN), the device also measures autonomic nervous system activity based on heart rate and respiratory rate. The high-sensitivity sensors of the Minori SCAN, placed under the mattress, detect subtle vibrations such as body movements to measure sleep and wakefulness.
Interventions/Control_3
During the intervention period, using the Oxytocin ELISA Kit, approximately 1.5 to 2 mL of blood will be collected from each participant while they are lying in bed preparing to sleep, one hour after a meal and at least five minutes after oral care has been completed.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals aged 65 or older residing in a senior care facility (regardless of gender)
2. Individuals for whom consent has been obtained from both the participant and their family (or legal representative)
3. Individuals who tested negative on an aromatherapy oil patch test
4. Individuals exhibiting BPSD symptoms
Key exclusion criteria
Any person who does not meet even one of the selection criteria
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | kumi |
| Middle name | |
| Last name | morizono |
Organization
University of Occupational and Environmental Health
Division name
School of Occupational Health
Zip code
8078555
Address
1-1 Iyashi-ga-oka, Yahata Nishi Ward
TEL
0936031611
su3658@health.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | kumi |
| Middle name | |
| Last name | morizono |
Organization
University of Occupational and Environmental Health
Division name
School of Occupational Health
Zip code
8078555
Address
1-1 Iyashi-ga-oka, Yahata Nishi Ward
TEL
0936031611
Homepage URL
su3658@health.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
University of Occupational and Environmental Health
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saga University
Name of secondary funder(s)
Hiroshima University Hospital
IRB Contact (For public release)
Organization
University of Occupational and Environmental Health
Address
1-1 Iyashi-ga-oka, Yahata Nishi Ward
Tel
0936031611
su3658@health.uoeh-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
産業医科大学（福岡県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 14 | 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 | 04 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | 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 | 05 | Month | 14 | Day |
Last modified on
| 2026 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070452
