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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040504
Receipt No. 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

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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
Obsterics 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
Email 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
Email shyuga@kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046234

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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