UMIN-CTR Clinical Trial

Basic information
Public title	Research on odor perception
Acronym	Research on odor perception
Scientific Title	Research on odor perception
Scientific Title:Acronym	Research on odor perception
Region	Japan

Condition
Condition	postpartum psychosis
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we will expand on previous research, measure brain activity using fMRI, quantify hormones involved in emotions such as oxytocin and corticoids, and investigate the physiological effects that occur with emotional changes caused by odors in newborns. be. Through this research, we will elucidate part of the action mechanism of odor communication by newborns, and further advance this research to scientifically deepen our understanding of human emotions, and attach to newborns as a social outlet for research results. The purpose is to contribute to solving social problems such as the prevention of abuse, such as the development of fragrances that encourage
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	We will image changes in brain activity caused by olfactory, visual, and auditory stimuli using fMRI, and compare and analyze the physiological effects that occur with emotional changes caused by odors (especially in newborns) by comparing them with other stimuli. Analysis software such as SPM is used to compare imaging data during stimulus presentation obtained by block design and imaging data at rest.
Key secondary outcomes	In parallel with fMRI imaging, oxytocin and corticoid hormones, which are involved in human emotions, were quantified by collecting saliva. Analysis is performed by t-test. In addition, a psychological questionnaire about odors will be conducted. Statistical analysis examined whether there was a significant difference between the presence and absence of odor stimuli in changes in hormone levels quantified by luminance measurement, and fitted a generalized linear model to the correlation with scores from psychological questionnaires. , to perform a likelihood ratio test.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
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Institution consideration
Blocking
Concealment

Intervention
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Eligibility
Age-lower limit	20 years-old <
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	none
Key exclusion criteria	none
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kazunao Middle name Last name Suzuki
Organization	Hamamastu University School of Medicine
Division name	Obstetrics&Gynecology
Zip code	431-3192
Address	Handayama1-20-1
TEL	0534352309
Email	dallascowboys1018@yahoo.co.jp

Public contact
Name of contact person	1st name Kazunao Middle name Last name Suzuki
Organization	Hamamastu University School of Medicine
Division name	Obstetrics&Gynecology
Zip code	431-3192
Address	Handayama1-20-1
TEL	0534352309
Homepage URL
Email	kazunaos@hama-med.ac.jp

Sponsor
Institute	Hamamastu University School of Medicine
Institute
Department

Funding Source
Organization	mnone
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hamamastu University School of Medicine
Address	Handayama1-20-1
Tel	0534352309
Email	kazunaos@hama-med.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	浜松医科大学

Other administrative information
Date of disclosure of the study information	2022 Year 08 Month 05 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
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Results Delayed
Results Delay Reason
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Suspended
Date of protocol fixation	2021 Year 05 Month 18 Day
Date of IRB	2020 Year 05 Month 18 Day
Anticipated trial start date	2021 Year 05 Month 18 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry	2026 Year 03 Month 31 Day
Date trial data considered complete	2026 Year 03 Month 31 Day
Date analysis concluded	2026 Year 03 Month 31 Day

Other
Other related information	none

Management information
Registered date	2022 Year 08 Month 05 Day
Last modified on	2022 Year 08 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055378