UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000057606
Receipt number R000065819
Scientific Title Development of a self-care program to enhance the resilience of mid-career female nurses
Date of disclosure of the study information 2025/04/30
Last modified on 2025/04/14 17:31:27

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Basic information

Public title

Development of a self-care program to enhance the resilience of mid-career female nurses

Acronym

Development of a self-care program to enhance the resilience of mid-career female nurses

Scientific Title

Development of a self-care program to enhance the resilience of mid-career female nurses

Scientific Title:Acronym

Development of a self-care program to enhance the resilience of mid-career female nurses

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Nursing Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effectiveness of a self-care program to enhance resilience among mid-career female nurses

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

A higher total score on the Nurse Resilience Scale.

Key secondary outcomes

A lower total score on the Psychological Stress Response Scale (SRS-18).
A higher total score on the Perceived Control Scale.


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

The program consists of two video training sessions and six homework assignments.

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

25 years-old <=

Age-upper limit

47 years-old >=

Gender

Female

Key inclusion criteria

1) Occupation: Ward nurse working at University Hospital A
2) Gender: Female
3) Working style: Full-time
4) Nursing experience: Mid-career nurse (3 years or more to 25 years or less of nursing experience)
5)Individuals who can obtain voluntary consent to participate in the study

Key exclusion criteria

1) Persons in managerial positions (such as head of nursing)

Target sample size

45


Research contact person

Name of lead principal investigator

1st name Masako
Middle name
Last name Murota

Organization

Kyoto Prefectural University of Medicine

Division name

School of Nursing

Zip code

602-8566

Address

Kyoto-shi, Kamigyo-ku Kajii-cho, Kawaramachi-Hirokoji, JAPAN

TEL

075-212-5437

Email

murota@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Masako
Middle name
Last name Murota

Organization

Kyoto Prefectural University of Medicine

Division name

School of Nursing

Zip code

602-8566

Address

Kyoto-shi, Kamigyo-ku Kajii-cho, Kawaramachi-Hirokoji, JAPAN

TEL

075-212-5437

Homepage URL


Email

murota@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

MEXT(Japan)

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

Kyoto Prefectural University of Medicine ,Medical Ethics Review Board

Address

Kyoto-shi, Kamigyo-ku Kajii-cho, Kawaramachi-Hirokoji, JAPAN

Tel

075-251-5337

Email

rinri@koto.kpu-m.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 04 Month 30 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

2025 Year 04 Month 14 Day

Date of IRB


Anticipated trial start date

2025 Year 06 Month 01 Day

Last follow-up date

2026 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

2025 Year 04 Month 14 Day

Last modified on

2025 Year 04 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065819