UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000053146
Receipt number R000060654
Scientific Title Scoping Review Protocol on the Mental Health of Midwives during the COVID-19 Pandemic
Date of disclosure of the study information 2024/02/01
Last modified on 2025/01/07 21:40:07

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Basic information

Public title

Scoping Review Protocol on the Mental Health of Midwives
during the COVID-19 Pandemic

Acronym

Scoping Review Protocol on the Mental Health of Midwives
during the COVID-19 Pandemic

Scientific Title

Scoping Review Protocol on the Mental Health of Midwives
during the COVID-19 Pandemic

Scientific Title:Acronym

Scoping Review Protocol on the Mental Health of Midwives
during the COVID-19 Pandemic

Region

Japan


Condition

Condition

Mental health

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This review will aim to comprehensively provide an understanding of the current state of midwives mental health in the context of the COVID-19 pandemic, offering valuable insights to guide future research.

Basic objectives2

Others

Basic objectives -Others

This review aims to address the following research questions
1 What are the research outcomes regarding midwives mental health during the COVID-19 pandemic?
2 What are the factors associated with the outcomes?
3 What are the results when compared to the pre-COVID-19 pandemic period?

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Mental health, stress, burnout, work engagement

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Inclusion criteria
This scoping review will include studies that collected data from participants meeting the following criteria:
1. In this scoping review, the years of publication for the reviewed literature are limited to January 2020 and onward.
2. Regarding language, papers written in English and in any language that the authors can accurately review will be included.
3. In this scoping review, the focus will be on major quantitative studies.
4. The review literature will be hand-searched for eligible literature and any non-duplicate literature will be included in this scoping review

Key exclusion criteria

1. Studies with investigation periods before November 2019 will be excluded.
2. Papers for which only the title and abstract are available, and the full text cannot be confirmed, will be excluded.
3. Qualitative studies and mixed methods will be excluded in this review.
4. Results compiled specifically as health-care practitioners and those where results related to midwifery cannot be identified will be excluded.

Target sample size



Research contact person

Name of lead principal investigator

1st name Mayumi
Middle name
Last name UCHIMURA

Organization

Saint Lukes International University

Division name

Graduate School of Nursing Science

Zip code

104-0044

Address

10-1 Akashi-cho, Chuo-ku, Tokyo 104-8560, Japan

TEL

03-3543-6391

Email

23dn002@slcn.ac.jp


Public contact

Name of contact person

1st name Mayumi
Middle name
Last name Uchimura

Organization

Saint Lukes International University

Division name

Graduate School of Nursing Science

Zip code

1750094

Address

10-1 Akashi-cho, Chuo-ku, Tokyo 104-8560, Japan

TEL

03-3543-6391

Homepage URL


Email

23dn002@slcn.ac.jp


Sponsor or person

Institute

Saint Lukes International University

Institute

Department

Personal name



Funding Source

Organization

Saint Lukes International 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

Saint Lukes International University

Address

10-1 Akashi-cho, Chuo-ku, Tokyo 104-8560, Japan

Tel

03-3543-6391

Email

23dn002@slcn.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

2024 Year 02 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications

https://onlinelibrary.wiley.com/doi/full/10.1111/jjns.12612

Number of participants that the trial has enrolled

14

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

Completed

Date of protocol fixation

2023 Year 11 Month 26 Day

Date of IRB

2023 Year 11 Month 26 Day

Anticipated trial start date

2023 Year 12 Month 18 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2024 Year 03 Month 31 Day

Date analysis concluded

2024 Year 03 Month 31 Day


Other

Other related information

English


Management information

Registered date

2023 Year 12 Month 18 Day

Last modified on

2025 Year 01 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060654