UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056175 |
|---|---|
| Receipt number | R000064191 |
| Scientific Title | Examining the Relationship Between Changes in Conflict Mindset, Subjective Stress and Health Status |
| Date of disclosure of the study information | 2024/11/18 |
| Last modified on | 2025/05/20 09:19:19 |
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Basic information
Public title
Examining the Relationship Between Changes in Conflict Mindset, Subjective Stress and Health Status
Acronym
Change in Conflict Mindset and Stress/Mental Health
Scientific Title
Examining the Relationship Between Changes in Conflict Mindset, Subjective Stress and Health Status
Scientific Title:Acronym
Change in Conflict Mindset and Stress/Mental Health
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to provide healthy university students with the opportunity to learn about the concept of constructive conflict mindset and to examine whether their perceptions, attitudes, psychological stress responses, and mental health change as a result.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Conflict Mindset Measure
Key secondary outcomes
Stress Response Scale-18, General Health Questionnaire-12
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Conflict mindset education program
Interventions/Control_2
Self-Learning Program
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) University students aged 20 years or older at the time of consent, enrolled in a medical-related department.
(2) Participants who provide voluntary informed consent after demonstrating a full understanding of the study's purpose and procedures.
Key exclusion criteria
Individuals who decline to participate in the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Kyougoku |
Organization
Kibi International University
Division name
School of Human Science
Zip code
7168508
Address
8 Iga, Takahashi, Okayama, Japan
TEL
0866229454
kyougoku@kiui.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Kyougoku |
Organization
Kibi International University
Division name
School of Human Science
Zip code
7168508
Address
8 Iga, Takahashi, Okayama, Japan
TEL
0866229454
Homepage URL
kyougoku@kiui.ac.jp
Sponsor or person
Institute
Kibi International University
Institute
Department
Personal name
Funding Source
Organization
JSPS
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
Kibi International University
Address
8, iga, Takahashi, Okayama, Japan
Tel
0866229454
kyougoku@kiui.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 | 11 | Month | 18 | 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
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 11 | Month | 18 | Day |
Last modified on
| 2025 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064191
