UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000062559
Receipt number R000071612
Scientific Title Implementation and Evaluation of a Program to Improve Public Health Nurses Support Skills for Mothers of Late Preterm Infants Using Experiential Learning Theory A Randomized Parallel-Group Comparative Trial
Date of disclosure of the study information 2026/08/12
Last modified on 2026/08/12 13:12:38

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Basic information

Public title

Implementation and Evaluation of a Program to Improve Public Health Nurses Practical Skills in Supporting Mothers of Late Preterm Infants Using Experiential Learning Theory

Acronym

Implementation and Evaluation of a Program to Improve Public Health Nurses Practical Skills in Supporting Mothers of Late Preterm Infants Using Experiential Learning Theory

Scientific Title

Implementation and Evaluation of a Program to Improve Public Health Nurses Support Skills for Mothers of Late Preterm Infants Using Experiential Learning Theory A Randomized Parallel-Group Comparative Trial

Scientific Title:Acronym

Implementation and Evaluation of a Program to Improve Public Health Nurses Support Skills for Mothers of Late Preterm Infants Using Experiential Learning Theory A Randomized Parallel-Group Comparative Trial

Region

Japan


Condition

Condition

Does not apply

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to implement and evaluate a program designed to improve public health nurses ability to provide support to mothers of late preterm infants, using experiential learning theory, and to verify the programs effectiveness.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Support Practice Competence (subscale of the Public Health Nurse Family Support Practice Competence Scale)

Key secondary outcomes



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


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Intervention group: Online program (conducted twice; first session: 120 minutes)

Interventions/Control_2

Intervention group: Online program (conducted twice; first session: 120 minutes)

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Public health nurses working in maternal and child health services in Japanese municipalities.

Key exclusion criteria

Public health nurses who are not engaged in maternal and child health services

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Chikage
Middle name
Last name Tsuzuki

Organization

Osaka Metropolitan University

Division name

Graduate School of Nursing

Zip code

545-0051

Address

1-5-17 Asahi-cho, Abeno-ku, Osaka

TEL

0666453511

Email

tsuzuki@omu.ac.jp


Public contact

Name of contact person

1st name Kunie
Middle name
Last name Michibata

Organization

Osaka Metropolitan University Graduate School

Division name

Doctoral Program in Nursing Science

Zip code

545-0051

Address

1-5-17 Asahi-cho, Abeno-ku, Osaka

TEL

0666453511

Homepage URL


Email

sf22146v@st.omu.ac.jp


Sponsor or person

Institute

Osaka Metropolitan University

Institute

Department

Personal name



Funding Source

Organization

Self-procurement

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka Metropolitan University

Address

1-5-17 Asahi-cho, Abeno-ku, Osaka

Tel

06-6645-3456

Email

gr-hab-rinri@omu.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



Other administrative information

Date of disclosure of the study information

2026 Year 08 Month 12 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

2026 Year 03 Month 12 Day

Date of IRB

2026 Year 04 Month 02 Day

Anticipated trial start date

2026 Year 05 Month 12 Day

Last follow-up date

2028 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2026 Year 08 Month 12 Day

Last modified on

2026 Year 08 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071612