UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000052153
Receipt number R000059524
Scientific Title Examining the appropriateness of a video-based sex education application on contraception for a non-medical college.
Date of disclosure of the study information 2023/11/01
Last modified on 2023/09/08 17:27:39

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Basic information

Public title

Examining the appropriateness of a video-based sex education application on contraception for a non-medical college.

Acronym

Examining the appropriateness of a video-based sex education application on contraception for a non-medical college.

Scientific Title

Examining the appropriateness of a video-based sex education application on contraception for a non-medical college.

Scientific Title:Acronym

Examining the appropriateness of a video-based sex education application on contraception for a non-medical college.

Region

Japan


Condition

Condition

College students in non-medical schools

Classification by specialty

Nursing Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the appropriateness of a video viewing sex education application on contraceptive knowledge offered to non-medical college students based on demographics such as gender and dating/sexual experience.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Compare the percentage of correct answers to contraceptive knowledge verification questions before and after using a video-based educational application on contraception.

Key secondary outcomes

Percentage of correct answers to questions confirming contraceptive knowledge in the group that has never had dating or sexual intercourse/Types of videos viewed/Questions about the appropriateness of the application and videos/Opinion requests regarding the application (free response)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

A group comparison of the percentage of correct answers to knowledge questions about contraception before and after the use of a video viewing application.

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

25 years-old >

Gender

Male and Female

Key inclusion criteria

Male and female college students in non-medical faculties

Key exclusion criteria

Those selecting "neither/would prefer not to answer" for gender other than male/female

Target sample size

68


Research contact person

Name of lead principal investigator

1st name Nana
Middle name
Last name Sasano

Organization

Osaka Medical and Pharmaceutical University

Division name

Faculty of Nursing

Zip code

569-0095

Address

7 6 Hacchounishimachi Takatukishi Osaka

TEL

072-683-1221

Email

nana.sasano@ompu.ac.jp


Public contact

Name of contact person

1st name Nana
Middle name
Last name Sasano

Organization

Osaka Medical and Pharmaceutical University

Division name

Faculty of Nursing

Zip code

569-0095

Address

7 6 Hacchounishimachi Takatukishi Osaka

TEL

072-683-1221

Homepage URL


Email

nana.sasano@ompu.ac.jp


Sponsor or person

Institute

Osaka Medical and Pharmaceutical University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education Culture Sports Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka Medical and Pharmaceutical University

Address

7 6 Hacchounishimachi Takatukishi Osaka

Tel

072-683-1221

Email

rinri@ompu.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

2023 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

Preinitiation

Date of protocol fixation

2023 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2023 Year 11 Month 01 Day

Last follow-up date

2025 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

2023 Year 09 Month 08 Day

Last modified on

2023 Year 09 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059524