UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055759 |
|---|---|
| Receipt number | R000063728 |
| Scientific Title | Effects of aromatherapy on anxiety and salivary oxytocin levels |
| Date of disclosure of the study information | 2024/10/07 |
| Last modified on | 2024/10/07 12:51:02 |
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Basic information
Public title
Effects of aromatherapy on anxiety and salivary oxytocin levels
Acronym
Effects of aromatherapy on anxiety and salivary oxytocin levels
Scientific Title
Effects of aromatherapy on anxiety and salivary oxytocin levels
Scientific Title:Acronym
Effects of aromatherapy on anxiety and salivary oxytocin levels
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of aromatherapy with lavender oil on anxiety level
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary oxytocin levels
Anxiety levels
Key secondary outcomes
Sex differences in primary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
The participants received a 30-min aromatherapy session with diffused aroma oil using Lavandula angustifolia in a room, and then they received a 10-min hand massage with aroma
oil. Saliva collecting, visual analogue scale (VAS) for subjective stress assessment, and the measurement of heart rate were performed before and after the aromatherapy, and after the hand massage.
Interventions/Control_2
The participants stayed in a room for 30 min without diffused aroma oil, and then they received a 10-min hand massage with carrier oil. Saliva collecting, visual analogue scale (VAS) for subjective stress assessment, and the measurement of heart rate were performed before and after the 30-min stay, and after the hand massage.
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
| 20 | years-old | < |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
Smokers
Individuals who were taking medication including traditional Chinese medicine
Pregnant or lactating women
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Maejima |
Organization
Fukushima Medical University
Division name
School of Medicine
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima
TEL
024-547-1152
maejimay@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Nagai |
Organization
Fukushima Medical University
Division name
Research Ethics Committee
Zip code
960-1295
Address
1 Hikarigaoka Fukushima
TEL
024-547-1825
Homepage URL
fmurec@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Aroma Environment Association of Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University Research Ethics Committee
Address
1 Hikarigaoka Fukushima
Tel
024-547-1825
fmurec@fmu.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
| 2024 | Year | 10 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2024.1380779/full
Number of participants that the trial has enrolled
25
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
| 2022 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | 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
| 2024 | Year | 10 | Month | 07 | Day |
Last modified on
| 2024 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063728
