UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000063169
Receipt number R000072194
Scientific Title Development of an Educational Tool for Kampo Medicine Using Simulated Videos Depicting Kampo Outpatient Care
Date of disclosure of the study information 2026/10/05
Last modified on 2026/09/27 14:56:55

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Basic information

Public title

Development of a Video-Based Educational Tool for Learning Kampo Outpatient Care

Acronym

Kampo Outpatient Video Education Study

Scientific Title

Development of an Educational Tool for Kampo Medicine Using Simulated Videos Depicting Kampo Outpatient Care

Scientific Title:Acronym

Kampo Outpatient Video Education Study

Region

Japan


Condition

Condition

Kampo medicine education for junior residents

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate, among junior residents, the additional educational effects of simulated videos depicting clinical care provided by Kampo medicine specialists on learners' understanding and knowledge acquisition when added to PDF-based learning materials, compared with PDF-based learning materials alone.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Co-primary outcomes:
1) Visual analogue scale (VAS) scores for interest in Kampo medicine, perceived need for Kampo medicine, and self-rated understanding of Kampo medicine
2) Kampo medicine mini-test scores
Both outcomes will be assessed at three time points: before the intervention (after informed consent and before randomization), 1 week after the intervention, and 2 months after the intervention.

Key secondary outcomes

Useful elements of the educational content identified from free-text responses. The responses will be analyzed using content analysis, and the identified elements will be categorized and summarized descriptively.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Participants in the intervention group will be provided, via online storage, with simulated videos depicting Kampo outpatient care provided by Kampo medicine specialists for three cases, together with PDF materials corresponding to the same cases. Participants will be instructed to complete the assigned learning within 1 week after allocation and not to share the materials with individuals outside the study.

Interventions/Control_2

Participants in the control group will be provided, via online storage, with PDF materials only for the same three cases. Participants will be instructed to complete the assigned learning within 1 week after allocation and not to share the materials with individuals outside the study.

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

24 years-old <=

Age-upper limit

40 years-old >=

Gender

Male and Female

Key inclusion criteria

Junior residents affiliated with the Postgraduate Clinical Training Center of Jichi Medical University Hospital or junior residents at Aso Iizuka Hospital who provide written informed consent to participate in the study.

Key exclusion criteria

Individuals who do not provide written informed consent to participate in the study.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Yashushi
Middle name
Last name Matsuyama

Organization

Jichi Medical University

Division name

Medical Education Center

Zip code

329-0498

Address

3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan

TEL

0285-58-7067

Email

yasushim@jichi.ac.jp


Public contact

Name of contact person

1st name Ryo
Middle name
Last name Yoshinaga

Organization

Jichi Medical University

Division name

Medical Education Center

Zip code

329-0498

Address

3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan

TEL

0285-58-7067

Homepage URL


Email

yoshinaga.ryo@jichi.ac.jp


Sponsor or person

Institute

Jichi Medical University

Institute

Department

Personal name



Funding Source

Organization

Japan Kampo Medicine Education Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor

Aso Iizuka hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Jichi Medical University Bioethics Committee for Medical Research

Address

3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan

Tel

0285-58-8933

Email

rinri@jichi.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 10 Month 05 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

Preinitiation

Date of protocol fixation

2026 Year 09 Month 27 Day

Date of IRB


Anticipated trial start date

2026 Year 10 Month 06 Day

Last follow-up date

2030 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 10 Month 04 Day

Last modified on

2026 Year 09 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072194