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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000028353 |
Receipt No. | R000032428 |
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 |
Date of disclosure of the study information | 2017/07/25 |
Last modified on | 2018/02/16 |
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 | |
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Condition | |||
Condition | Pregnant women and fetuses after 36 weeks gestation have no abnormality in the course of pregnancy | ||
Classification by specialty |
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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 |
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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. |
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Eligibility | ||||
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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 |
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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 |
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Target sample size | 15 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
16mz004c@shinshu-u.ac.jp |
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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 | |||||||
16mz004c@shinshu-u.ac.jp |
Sponsor | |
Institute | Shinshu University graduate school |
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Organization | Shinshu University graduate school |
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Category of Funding Organization | Other |
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Secondary IDs | NO |
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IND to MHLW |
Institutions | |
Institutions | 信州大学医学部附属病院(長野県) |
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Date of disclosure of the study information |
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URL releasing protocol | |
Publication of results | Unpublished |
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Recruitment status | No longer recruiting | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032428 |
Research Plan | |
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Research case data | |
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