UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056323 |
|---|---|
| Receipt number | R000064350 |
| Scientific Title | Effects of Aromatherapy on Autonomic Nervous System Activity in Patients with Acute Coronary Syndrome |
| Date of disclosure of the study information | 2024/12/03 |
| Last modified on | 2025/06/02 09:12:52 |
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Basic information
Public title
Effects of Aromatherapy on Autonomic Nervous System Activity in Patients with Heart Disease
Acronym
Aromatherapy in Heart Disease
Scientific Title
Effects of Aromatherapy on Autonomic Nervous System Activity in Patients with Acute Coronary Syndrome
Scientific Title:Acronym
Aromatherapy in Acute Coronary Syndrome
Region
| Japan |
Condition
Condition
Acute Coronary Syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of aromatherapy on autonomic nervous system activity and vital signs in patients with acute coronary syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the high-frequency component of heart rate variability at 5, 10, 15, and 20 minutes after the initiation of aromatherapy.
Key secondary outcomes
RMSSD, low-frequency component and LF/HF ratio of heart rate variability, heart rate, blood pressure, respiratory rate, SpO2, preference for aroma, emotional responses to aroma
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
After a 10-minute period of rest in a seated position, aromatherapy using an aroma diffuser will be administered for 20 minutes.
The aroma will be provided using lavender essential oil.
The washout period will be set to 3 to 5 days.
Interventions/Control_2
After a 10-minute period of rest in a seated position, aromatherapy using an aroma diffuser will be administered for 20 minutes.
The aroma will be provided using distilled water.
The washout period will be set to 3 to 5 days.
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
Diagnosed with acute coronary syndrome by a cardiologist and successfully underwent percutaneous coronary intervention (PCI).
Key exclusion criteria
After cardiopulmonary resuscitation, respiratory diseases such as asthma and COPD, a history of allergies to essential oils, olfactory disorders, mental disorders, chronic respiratory diseases such as bronchitis and atelectasis, dementia severe enough to prevent participation in the experiment, arrhythmias, and acute deterioration of respiratory or circulatory dynamics or allergic reactions during the experiment.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Katsuki |
| Middle name | |
| Last name | Okada |
Organization
Ehime Prefectural Imabari Hospital
Division name
Rehabilitation Department
Zip code
794-0006
Address
4-5-5 Ishii-cho, Imabari City, Ehime Prefecture, Japan
TEL
0898-32-7111
katsuki.okada7@gmail.com
Public contact
Name of contact person
| 1st name | Katsuki |
| Middle name | |
| Last name | Okada |
Organization
Ehime Prefectural Imabari Hospital
Division name
Rehabilitation Department
Zip code
794-0006
Address
4-5-5 Ishii-cho, Imabari City, Ehime Prefecture, Japan
TEL
0898-32-7111
Homepage URL
katsuki.okada7@gmail.com
Sponsor or person
Institute
Ehime Prefectural Imabari Hospital, Rehabilitation Department
Institute
Department
Personal name
Funding Source
Organization
None
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
Ehime Prefectural Imabari Hospital
Address
4-5-5 Ishii-cho, Imabari City, Ehime Prefecture, Japan
Tel
0898-32-7111
katsuki.okada7@gmail.com
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 | 12 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 23 | 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 | 12 | Month | 01 | Day |
Last modified on
| 2025 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064350
