UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028471 |
|---|---|
| Receipt number | R000031013 |
| Scientific Title | Physiological and Psychological Changes of Primipara after First-time Interaction with Infant during Pregnancy |
| Date of disclosure of the study information | 2017/08/02 |
| Last modified on | 2019/05/30 22:39:56 |
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Basic information
Public title
Physiological and Psychological Changes of Primipara after First-time Interaction with Infant during Pregnancy
Acronym
Physiological and Psychological Changes of Primipara after First-time Interaction with Infant during Pregnancy
Scientific Title
Physiological and Psychological Changes of Primipara after First-time Interaction with Infant during Pregnancy
Scientific Title:Acronym
Physiological and Psychological Changes of Primipara after First-time Interaction with Infant during Pregnancy
Region
| Japan |
Condition
Condition
Low-risk primipara 38weeks of gestation.
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Comparing two groups to cralify the evidence of interact with infant.
Hypotheses:
1.The level of cortisol in intervention group is more decrease than controal group after intervention.
2.The score of STAI in intervention group is more decrease than control group after intervention.
3.The level of oxytoin in intervention group is more higer than controal group after intervention.
4.The score of TAIJI-KANJYO-SHAKUDO in intervention group is more change than controal group after intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of salivary cortisol before and after interaction.
Key secondary outcomes
1.Change of salivary oxytocin before and after interaction.
2.Change of score of STAI.
3.Change of score of TAIJI-KANJYO-SHAKUDO.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
30min of interacting with infant
Interventions/Control_2
30min of seeing DVD of infant
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
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Low-risk primipara
2.Japanese
3.Plan to give birth with spontaneous delivary
4.More than 20years old
5.38weeks gestation
Key exclusion criteria
1.Complications of pregnancy
2.Current medical history or past history of endocrine disorders and psychiatric disorders
3.Oral or dental diseases
4.Professional child care-giver
5.Those performing nipple massage for induction of delivary
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeko Horiuchi |
Organization
St. Luke's International University, Postgraduate School
Division name
Nursing science, Women's Health and Midwifery
Zip code
Address
10-1, Akashi-cho, Chuo-ku, Tokyo, 104-0044, Japan
TEL
03-3543-6391
shigeko-horiuchi@slcn.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nozomi Sonoda |
Organization
St. Luke's International University, Postgraduate School
Division name
Nursing science, Women's Health and Midwifery
Zip code
Address
3-8-5, Tsukiji, Cuo-ku, Tokyo, 104-0045, Japan
TEL
03-6226-6361
Homepage URL
15DN010@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
KAKEN(16K15939)
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 | 08 | Month | 02 | 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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 31 | Day |
Last modified on
| 2019 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031013
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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