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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029568
Receipt No. R000033771
Scientific Title The investigation of individual and situational differences of effects of oxytocin administration on maternal responses to infant crying
Date of disclosure of the study information 2017/10/16
Last modified on 2017/10/16

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Basic information
Public title The investigation of individual and situational differences of effects of oxytocin administration on maternal responses to infant crying
Acronym The influence of oxytocin on responses to infant crying
Scientific Title The investigation of individual and situational differences of effects of oxytocin administration on maternal responses to infant crying
Scientific Title:Acronym The influence of oxytocin on responses to infant crying
Region
Japan

Condition
Condition Postpartum depression
Classification by specialty
Hepato-biliary-pancreatic medicine Not applicable Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 In this study, we will investigate whether individual difference or situational difference which are assumed to interfere with emotional regulation would modify the effects of oxytocin administration on response to infant crying.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes heart rate variability during listing to infant crying
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Medicine
Interventions/Control_1 Syntocinon spray, 24UI, once
Interventions/Control_2 physiological saline solution, 24UI, once
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
60 years-old >
Gender Female
Key inclusion criteria during nurturing their infant or toddeler
Key exclusion criteria during pregnancy or lactating
Target sample size 34

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michio Nomura
Organization Kyoto University
Division name Graduate school of Education
Zip code
Address YoshidaHonMachi, Sakyoku, Kyoto-shi, Kyoto pref.
TEL 075-753-3004
Email nomura.michio.8u@kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daiki Hiraoka
Organization Kyoto University
Division name Graduate school of Education
Zip code
Address YoshidaHonMachi, Sakyoku, Kyoto-shi, Kyoto pref.
TEL 075-753-3967
Homepage URL
Email hiraoka.daiki.54r@st.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Kyoto University
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
Address
Tel
Email

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
2017 Year 10 Month 16 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
2017 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 16 Day
Last modified on
2017 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033771

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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