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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028471
Receipt No. 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 2018/02/03

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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
Last 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
Email shigeko-horiuchi@slcn.ac.jp

Public contact
1st 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
Email 15DN010@slcn.ac.jp

Sponsor
Institute St. Luke's International University
Institute
Department

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
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 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 Enrolling by invitation
Date of protocol fixation
2017 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 15 Day
Last follow-up date
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
2018 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031013

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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