UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000059578
Receipt number R000068142
Scientific Title Feasibility Study on the Integration of Ultrasound in Physical Assessment Training in Basic Nursing Education
Date of disclosure of the study information 2025/11/01
Last modified on 2025/10/29 13:15:17

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Basic information

Public title

Feasibility Study on the Integration of Ultrasound in Physical Assessment Training in Basic Nursing Education

Acronym

Feasibility Study on the Integration of Ultrasound in Basic Nursing Education

Scientific Title

Feasibility Study on the Integration of Ultrasound in Physical Assessment Training in Basic Nursing Education

Scientific Title:Acronym

Feasibility Study on the Integration of Ultrasound in Basic Nursing Education

Region

Japan


Condition

Condition

None

Classification by specialty

Nursing Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In this study, nursing faculty members and undergraduate nursing students who had no prior experience with ultrasound practice in basic nursing education were included as participants. The purpose of this study was to determine whether ultrasound practice could be implemented using educational materials designed for nursing students, and to evaluate the effects of conducting ultrasound practice.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Knowledge and skills acquired by faculty and students

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Maneuver

Interventions/Control_1

Introducing ultrasound into physical assessment skills training in basic nursing education

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

18 years-old <=

Age-upper limit

63 years-old >=

Gender

Male and Female

Key inclusion criteria

Faculty Members

1.Faculty members who provided written informed consent based on sufficient explanation, full understanding, and their own free will prior to participation in this study.

2.Faculty members aged 18 years or older at the time of consent.

3.Faculty members who may have had prior experience using ultrasound but had never been in charge of on-campus training that applied ultrasound to physical assessment techniques.


Students

1.Students who voluntarily completed the questionnaire after receiving adequate explanation of the study and providing informed consent based on sufficient understanding and their own free will.

2.Students aged 18 years or older at the time of consent.

3.Students who had no prior knowledge or skills related to ultrasound and had not participated in any on-campus training that incorporated ultrasound into physical assessment techniques.

Key exclusion criteria

Individuals deemed inappropriate for participation by the principal investigator or co-investigators.

Target sample size

940


Research contact person

Name of lead principal investigator

1st name Kimie
Middle name
Last name Takehara

Organization

Fujita Health University

Division name

School of Health Sciences

Zip code

4701192

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi

TEL

0562-93-2554

Email

kimie.takehara@fujita-hu.ac.jp


Public contact

Name of contact person

1st name Kimie
Middle name
Last name Takehara

Organization

Fujita Health University

Division name

School of Health Sciences

Zip code

4701192

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi

TEL

0562-93-2554

Homepage URL


Email

kimie.takehara@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health University

Institute

Department

Personal name



Funding Source

Organization

The Society for Nursing Science and Engineering

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

Fujita Medical University Medical Research Ethics Review Committee

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi

Tel

0562-93-2554

Email

kimie.takehara@fujita-hu.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

2025 Year 11 Month 01 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

Enrolling by invitation

Date of protocol fixation

2025 Year 10 Month 29 Day

Date of IRB

2025 Year 07 Month 31 Day

Anticipated trial start date

2025 Year 11 Month 01 Day

Last follow-up date

2026 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2025 Year 10 Month 29 Day

Last modified on

2025 Year 10 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068142