UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040504 |
|---|---|
| Receipt number | R000046234 |
| Scientific Title | The exploratory study on the effect of aromatherapy using essential oil of Parmarosa on the autonomic nervous system of pregnant women during cesarean section |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2020/05/24 14:33:51 |
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Basic information
Public title
Relaxing effects of aromatherapy during cesarean section
Acronym
Relaxing effects of aromatherapy during cesarean section
Scientific Title
The exploratory study on the effect of aromatherapy using essential oil of Parmarosa on the autonomic nervous system of pregnant women during cesarean section
Scientific Title:Acronym
The exploratory study on the effect of aromatherapy using essential oil of Parmarosa on the autonomic nervous system of pregnant women during cesarean section
Region
| Japan |
Condition
Condition
Pregnancy
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is common for cesarean section to be performed while awake under regional anesthesia, and many pregnant women complain of discomfort, anxiety, and fear of abdominal manipulation. It has been reported that the use of music and other means to remove these anxieties and fears and, as a result, the autonomic nervous system of the pregnant woman becomes parasympathetic, thereby reducing circulatory fluctuations before and after anesthesia.
Aromatherapy has long been used in obstetrics and has been reported to be effective in relieving pain and anxiety in pregnant women during transvaginal delivery.
In this study, we investigate how aromatherapy with Parmarosa essential oil during cesarean section affects the autonomic nervous system of pregnant women. This is an exploratory study to examine whether there is a difference in autonomic nervous system activity between the essential oil aspiration group and the placebo aspiration group using heart rate variability analysis.
Basic objectives2
Others
Basic objectives -Others
Comparing the physiological changes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare heart rate variability after the delivery of a baby by cesarean section with a group of patients receiving Palmarosa essential oil (P group) and a group of patients receiving placebo (N group)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
| Other |
Interventions/Control_1
Inhaling Palmarosa essential oil
Interventions/Control_2
Inhaling placebo (purified water)
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Pregnant women who are scheduled for elective cesarean section and who have given consent to participate in the study
Patients with ASA physical status 1 or 2 with normotensive blood pressure and no proteinuria
Key exclusion criteria
Chronic use of any drug, smoking, hypertension, diabetes, thyroid disease, nerve palsy, serious fetal malformations, allergies to alcohol or rice plants, pregnant women whose fetus is dying or has heart disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Okutomi |
Organization
Kitasato university
Division name
Department of anesthesiology, school of medicine
Zip code
2280375
Address
1-15-1 Kitasato, Minami-Ku Sagamihara City
TEL
042-778-8606
tokutomi@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
2280375
Address
1-15-1 Kitasato, Minami-Ku Sagamihara City
TEL
042-778-8606
Homepage URL
shyuga@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Sel 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
The Kitasato Institute,Clinical Research Review Board
Address
1-15-1 Kitasato, Minami-Ku Sagamihara City
Tel
042-778-8273
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 01 | 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
| 2020 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2020 | Year | 05 | Month | 24 | Day |
Last modified on
| 2020 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046234
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
