UMIN-CTR Clinical Trial

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