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Name
UMIN ID

Recruitment status Suspended
Unique ID issued by UMIN UMIN000048601
Receipt No. R000055378
Scientific Title Research on odor perception
Date of disclosure of the study information 2022/08/05
Last modified on 2022/08/05

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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
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
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
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 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

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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