UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057620 |
|---|---|
| Receipt number | R000065793 |
| Scientific Title | Study of assessment indicators of stress in hospital ward nurses |
| Date of disclosure of the study information | 2025/04/15 |
| Last modified on | 2025/04/15 15:50:50 |
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Basic information
Public title
Study of stress assessment indicators for nurses
Acronym
Study of stress assessment indicators for nurses
Scientific Title
Study of assessment indicators of stress in hospital ward nurses
Scientific Title:Acronym
Study of assessment indicators of stress in hospital ward nurses
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine indicators for the assessment of stress among nurses in the ward.
Basic objectives2
Others
Basic objectives -Others
We conduct observational study using questionnaires and saliva samples.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following items, which measure stress reactions, are the main results.
1. Mental health survey (GHQ-12)
2. Emotional labor scale
3. Fatigue scale
4. Emotional rating using VAS
5. Salivary alpha-amylase, chromogranin A and cortisol
Key secondary outcomes
1. Job stress
2. Burnout
3. Utrecht Work Engagement Scale
4. Sense of Coherence
5. Physical activity and sleep
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Gender: Female
(2) Age: 35 years old or younger
(3) Nurses working on the ward
Key exclusion criteria
(1) Smokers
(2) Those with underlying disease
(3) Those currently taking any medication
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Murata |
Organization
Kawasaki City College of Nursing
Division name
Faculty of Nursing
Zip code
2120054
Address
4-30-1 Ogura, Saiwai-ku, Kawasaki city, Kanagawa, JAPAN
TEL
044-587-3500
murata-s@kawasaki-cn.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Murata |
Organization
Kawasaki City College of Nursing
Division name
Faculty of Nursing
Zip code
2120054
Address
4-30-1 Ogura, Saiwai-ku, Kawasaki city, Kanagawa, JAPAN
TEL
044-587-3500
Homepage URL
murata-s@kawasaki-cn.ac.jp
Sponsor or person
Institute
Kawasaki City College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Kawasaki City College of Nursing Research Ethics Committee
Address
4-30-1 Ogura, Saiwai-ku, Kawasaki city, Kanagawa, JAPAN
Tel
044-587-3500
utatsu-n@city.kawasaki.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 | 15 | 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 | 03 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a cross-sectional observational study using a questionnaire survey and saliva samples.
Management information
Registered date
| 2025 | Year | 04 | Month | 15 | Day |
Last modified on
| 2025 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065793
