UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035249
Receipt number 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 2021/06/25 14:49:09

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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 Yumiko
Middle name
Last name Otsuka-Sakuma

Organization

Setsunan University

Division name

Faculty of Nursing

Zip code

573-0101

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 Yumiko
Middle name
Last name Otsuka-Sakuma

Organization

Setsunan University

Division name

Faculty of Nursing

Zip code

573-0101

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 or person

Institute

Faculty of Nursing, Setsunan University

Institute

Department

Personal name



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

Setsunan University

Address

45-1 Nagaotoge-cho, Hirakata City, Osaka, 573-0101, Japan

Tel

+81(0)72-896-5870

Email

yumiko.sakuma@nrs.setsunan.ac.jp


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

Completed

Date of protocol fixation

2018 Year 03 Month 30 Day

Date of IRB

2018 Year 03 Month 06 Day

Anticipated trial start date

2018 Year 12 Month 01 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry

2022 Year 03 Month 31 Day

Date trial data considered complete

2022 Year 03 Month 31 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 12 Month 13 Day

Last modified on

2021 Year 06 Month 25 Day



Link to view the page

Value
https://center6.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