UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059312 |
|---|---|
| Receipt number | R000067730 |
| Scientific Title | Effects of Aromatherapy on Parasympathetic Activity in Parturients Under Neuraxial Labor Analgesia A Prospective Interventional Study |
| Date of disclosure of the study information | 2025/10/08 |
| Last modified on | 2025/10/07 10:33:03 |
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Basic information
Public title
Does aromatherapy during neuraxial labor analgesia enhance relaxation? An evaluation using the Analgesia/Nociception Index (ANI)
Acronym
AROMA-ANI
Scientific Title
Effects of Aromatherapy on Parasympathetic Activity in Parturients Under Neuraxial Labor Analgesia A Prospective Interventional Study
Scientific Title:Acronym
AROMA-ANI
Region
| Japan |
Condition
Condition
Pregnancy
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the degree of parasympathetic activity (measured by ANI) under two conditions during neuraxial labor analgesia: (1) adequate analgesia alone and (2) adequate analgesia combined with aromatherapy (inhalation).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of ANI before and after aromatherapy in parturients undergoing induction of labor under neuraxial analgesia (PRE vs POST).
Key secondary outcomes
Blood pressure, heart rate, labor progress (e.g., cervical dilation), and sensory block level.
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Aromatherapy
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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Parturients at Kitasato University Hospital who are scheduled for induction of labor with neuraxial analgesia, are at > = 37 weeks gestation, have ASA Physical Status II, and provide written informed consent.
Key exclusion criteria
Exclusion Criteria
1.Parturients in whom neuraxial analgesia is not feasible
2.Parturients unable to communicate effectively
3.Parturients on chronic medication (excluding vitamins or other supplements)
4.Parturients with a psychiatric disorder requiring treatment
5.Parturients with pre-existing ECG abnormalities
6.Parturients with hypertensive disorders of pregnancy
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | SHUNSUKE |
| Middle name | |
| Last name | HYUGA |
Organization
Kitasato University
Division name
Department of Anesthesiology, School of Medicine
Zip code
2520375
Address
1-15-1 Kitasato, Minami-ku, Sagamihara City, Kanagawa Prefecture
TEL
042-778-8606
shyuga@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | SHUNSUKE |
| Middle name | |
| Last name | HYUGA |
Organization
Kitasato university
Division name
Department of Anesthesiology, School of Medicine
Zip code
2520375
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan
TEL
042-778-8606
Homepage URL
shyuga@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato Univiersity
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
Kitasato University Medical Ethics Organization
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan
Tel
0427788111
rinrib@med.kitasato-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
北里大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 08 | 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
| 2025 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 10 | Month | 07 | Day |
Last modified on
| 2025 | 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=R000067730
