UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048618
Receipt number R000055396
Scientific Title Educational effects of the practicum participating simulated birthing women for midwifery students just prior to practice: changes in willingness for clinical practice.
Date of disclosure of the study information 2022/08/07
Last modified on 2024/02/27 16:56:30

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Basic information

Public title

Verification of whether the simulation practicum on-campus for students becoming midwives change their willingness toward clinical practice.

Acronym

Changes in students' willingness to practice midwifery.

Scientific Title

Educational effects of the practicum participating simulated birthing women for midwifery students just prior to practice: changes in willingness for clinical practice.

Scientific Title:Acronym

Educational effects of the practicum participating simulated parturient women for midwifery students just prior to practice.

Region

Japan


Condition

Condition

Willingness of midwifery students preparing for assisted childbirth practice.

Classification by specialty

Nursing Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify whether midwifery students' simulation practicum of childbirth assistance with the participation of simulated birthing women on campus as a preliminary stage of childbirth assistance practice reduces excessive anxiety and fear and improves their "willingness to practice," which is the positive and proactive attitude toward practice.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Midwifery students' willingness for practical training for assisted childbirth. Using the "Midwifery Students' Willingness to Practice Scale," a questionnaire will be used to measure and compare before and after the simulation practicum.

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

Other

Interventions/Control_1

One on-campus childbirth assistance simulation practicum of 2 hours per session in which a simulated birthing woman performs the first and second stages of labor.

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

21 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

A midwifery student who is enrolled in the midwifery course of the Nursing Department of University A who is about to undergo assisted childbirth practice.

Key exclusion criteria

None

Target sample size

44


Research contact person

Name of lead principal investigator

1st name Akiko
Middle name
Last name Higashihara

Organization

Saitama Prefectural University

Division name

Department of Nursing

Zip code

343-8540

Address

820 Sannomiya, Koshigaya-shi, Saitama, Japan.

TEL

048-973-4175

Email

higashihara-akiko@spu.ac.jp


Public contact

Name of contact person

1st name Akiko
Middle name
Last name Higashihara

Organization

Saitama Prefectural University

Division name

Department of Nursing

Zip code

343-8540

Address

820 Sannomiya, Koshigaya-shi, Saitama, Japan.

TEL

048-973-4175

Homepage URL


Email

higashihara-akiko@spu.ac.jp


Sponsor or person

Institute

Saitama Prefectural University

Institute

Department

Personal name



Funding Source

Organization

Saitama Prefectural University

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

Saitama Prefectural University Ethics Committee

Address

820 Sannomiya, Koshigaya-shi, Saitama, Japan.

Tel

048-973-4120

Email

rinri@spu.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

2022 Year 08 Month 07 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

44

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

No longer recruiting

Date of protocol fixation

2022 Year 08 Month 07 Day

Date of IRB

2022 Year 08 Month 02 Day

Anticipated trial start date

2022 Year 08 Month 07 Day

Last follow-up date

2024 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

2022 Year 08 Month 07 Day

Last modified on

2024 Year 02 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055396


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name