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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035249
Receipt No. R000040158
Scientific Title Development of Remote Health Support for Nurses during Pregnancy and Childbirth
Date of disclosure of the study information 2018/12/13
Last modified on 2019/07/04

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Basic information
Public title Development of Remote Health Support for Nurses during Pregnancy and Childbirth
Acronym Remote support for nurses during pregnancy/ childbirth
Scientific Title Development of Remote Health Support for Nurses during Pregnancy and Childbirth
Scientific Title:Acronym Remote support for nurses during pregnancy/ childbirth
Region
Japan

Condition
Condition Pregnant nurses
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to examine the effect of remote support for nursing professionals during pregnancy and childbirth.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Physical condition and mood during pregnancy and childbirth, Parenting Self-efficacy (Before intervention,20th,24th,28th,32th and 36th weeks of gestation, one month and two month after childbirth)
Key secondary outcomes Self-care behavior intentions and the status of practical self-care behavior during pregnancy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom Other
Interventions/Control_1 Once every four weeks, the intervention group will receive Evidence-Based information by internet service. Additionally, those in the intervention group can feel free to consult a midwife about distress or life during pregnancy.

Interventions/Control_2 The control group answers only questionnaire surveys.
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

Not applicable
Gender Female
Key inclusion criteria Healthy nurses who had normal pregnancies.
Key exclusion criteria We exclusion criteria are nurses who had abnormal pregnancy and poor physical or mental condition.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yumiko.Otsuka-Sakuma
Organization Setsunan University
Division name Faculty of Nursing
Zip code
Address 45-1 Nagaotoge-cho, Hirakata City, Osaka, 573-0101, Japan
TEL +81(0)72-896-5870
Email yumiko.sakuma@nrs.setsunan.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumiko.Otsuka-Sakuma
Organization Setsunan University
Division name Faculty of Nursing
Zip code
Address 45-1 Nagaotoge-cho, Hirakata City, Osaka, 573-0101, Japan
TEL +81(0)72-896-5870
Homepage URL
Email yumiko.sakuma@nrs.setsunan.ac.jp

Sponsor
Institute Faculty of Nursing, Setsunan University
Institute
Department

Funding Source
Organization MEXT(Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization MEXT JSPS KAKENHI Grant

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 A病院(大阪府) 他

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 13 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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 01 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
2018 Year 12 Month 13 Day
Last modified on
2019 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040158

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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