UMIN-CTR Clinical Trial

Basic information
Public title	Influence of pregnant women's reading of picture books on autonomic nervous functions of fetuses and pregnant women, psychological aspect of pregnant women, sleep arousal state of the fetus and fetal movement
Acronym	Influence of pregnant women's reading of picture books on autonomic nervous functions of fetuses and pregnant women, psychological aspect of pregnant women, sleep arousal state of the fetus and fetal movement
Scientific Title	Influence of pregnant women's reading of picture books on autonomic nervous functions of fetuses and pregnant women, psychological aspect of pregnant women, sleep arousal state of the fetus and fetal movement
Scientific Title:Acronym	Influence of pregnant women's reading of picture books on autonomic nervous functions of fetuses and pregnant women, psychological aspect of pregnant women, sleep arousal state of the fetus and fetal movement
Region	Japan

Condition
Condition	Pregnant women and fetuses after 36 weeks gestation have no abnormality in the course of pregnancy
Classification by specialty	Obsterics and gynecology Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1) Changes in autonomic nervous function of pregnant women and fetuses when pregnant women read a picture book to a fetus after 36 weeks gestation 2) Comparison of changes in autonomic nervous function when a pregnant woman reads a picture book to the fetus, when Warble tone (electronic sound) is heard, and when an adult woman other than pregnant reads a picture book . 3) Consider the linkage between autonomic nervous functions of pregnant women and fetuses. 4) To examine the influence of pregnant women reading a picture book to a fetus on feelings and love of pregnant women. 5) Consider the relationship between pregnant woman's and fetus's autonomic nervous function, heart rate, pregnant woman's respiration rate, pregnant woman's psychological index, fetal sleep arousal state, fetal movement
Basic objectives2	Others
Basic objectives -Others	We will clarify the influence of speech from pregnant woman to fetus on autonomic nervous function of pregnant woman and fetus, consider ways to deepen parent-child ties from pregnancy period.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Analysis of changes in autonomic nervous functions of pregnant women and fetuses using heart rate variation for resting before auditory stimulation, during auditory stimulation and at rest after auditory stimulation.
Key secondary outcomes	Evaluate psychological changes of pregnant women before and after auditory stimulation and changes in affection for fetus using self-written questionnaire. Also evaluate maternal vital signs (respiration rate, heart rate, body temperature), fetal movement, sleep arousal state which may affect autonomic nerve function.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	For pregnant women and fetuses, first observe the fetal heartbeat baseline for 3 minutes by fetal heart rate monitoring. Next,when a pregnant woman reads a picture book to a fetus, when an adult woman reads a picture book, when pregnant woman and fetus were heard warble tone, observe the autonomic nervous function. Let the subject decide the order of presenting three auditory stimuli by lottery, and measure continuously after each auditory stimulus with 20 minutes rest time in between. The time required for the experiment is 80 minutes.
Interventions/Control_2
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	35 years-old >
Gender	Female
Key inclusion criteria	1.There is no abnormality in the course of pregnancy 2.Over 20 years old and under 35 years old 3.Pregnant women who can cooperate research after 36 weeks gestation 4.Vaginal delivery planned 5.No complications 6.Not smoking 7.Pregnant women who can cooperate research from 13 o'clock to 17 o'clock 8.Pregnant women who do not have psychological / social problems 9.Pregnant women who can cooperate in questionnaire survey
Key exclusion criteria	1.Pregnant women with labor 2.Pregnant woman breaking water 3.Pregnant women who can not understand Japanese 4.Within 1 hour from the last meal intake
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Middle name Last name Asuka Machida
Organization	Shinshu University graduate school
Division name	Graduate School of Medicine
Zip code
Address	3-1-1 Asahi Matsumoto city Nagano prefecture
TEL	0263-37-2384
Email	16mz004c@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Asuka Machida
Organization	Shinshu University graduate school
Division name	Graduate School of Medicine
Zip code
Address	Asahi, Matsumoto city, Nagano prefecture
TEL	0263-37-2384
Homepage URL
Email	16mz004c@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University graduate school
Institute
Department

Funding Source
Organization	Shinshu University graduate school
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	信州大学医学部附属病院（長野県）

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 25 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	No longer recruiting
Date of protocol fixation	2017 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date	2017 Year 07 Month 25 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 07 Month 24 Day
Last modified on	2018 Year 02 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032428

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.