UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053832 |
|---|---|
| Receipt number | R000061443 |
| Scientific Title | Exploring Coping Strategies for Difficult Situations in Nursing Practice: Preliminary Survey for Database Development |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2024/03/12 10:31:40 |
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Basic information
Public title
Survey on Difficult Situations Encountered in Nursing Practice and How to Deal with Them
Acronym
An Investigation into Difficult Situations Faced by Nurses in Practice
Scientific Title
Exploring Coping Strategies for Difficult Situations in Nursing Practice: Preliminary Survey for Database Development
Scientific Title:Acronym
Survey on Difficult Situations Encountered and Coping Strategies in Nursing Practice
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to systematize difficult situations and responses by identifying difficult situations and responses experienced by nurses from a questionnaire survey and an interview survey, and to provide basic data for constructing a database to search for measures for difficult situations.
Basic objectives2
Others
Basic objectives -Others
Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Difficult situations experienced by nurses
2. Subjects experiencing difficulties
3. The place where the difficult situation occurred
4. Timeline of difficult cases
5. Coping methods implemented for the difficulties
Key secondary outcomes
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Japanese nursing professionals who work in medical facilities, government agencies, home nursing stations, companies, etc. and are registered as monitors with marketing companies
Key exclusion criteria
Any of the following will not be included in this study to ensure the reliability of the research data.
1. Responses with many inconsistencies
2. The same answers are repeated.
3. Many sentences in the free response column whose meaning cannot be read.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Arashi |
Organization
Kawasaki City College of Nursing
Division name
Mental Health Nursing
Zip code
212-0054
Address
4-30-1 ogura saiwai kawasaki-city, Kanagawa Japan
TEL
+81-44-587-5707
arashi-h@kawasaki-cn.ac.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Arashi |
Organization
Kawasaki City College of Nursing
Division name
Mental Health Nursing
Zip code
212-0054
Address
4-30-1 ogura saiwai kawasaki-city, Kanagawa Japan
TEL
+81-44-587-5707
Homepage URL
arashi-h@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 kawasaki-city, Kanagawa Japan
Tel
+81-44-587-3500
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
| 2024 | Year | 03 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study is a mixed study consisting of a quantitative descriptive study using a self-administered, unmarked questionnaire survey and a content analysis of qualitative data from individual interviews.
The questionnaire used in the survey was developed from data on difficult situations experienced by nurses extracted from social networking sites (SNS).
Additionally, interviews are conducted with respondents from the survey to gain in-depth insights into the specific cases.
Through the synthesis of questionnaire survey outcomes and interview findings, our aim is to elucidate and organize the challenging situations encountered by nurses along with their corresponding responses in a systematic manner.
Management information
Registered date
| 2024 | Year | 03 | Month | 12 | Day |
Last modified on
| 2024 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061443
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
