UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029568 |
|---|---|
| Receipt number | 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 10:30:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hiraoka.daiki.54r@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033771
