UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034180 |
|---|---|
| Receipt number | R000038968 |
| Scientific Title | Optimism, self-efficacy, and stress levels among fourth year nursing students following a brief positive psychology intervention, Tohoku University, Japan |
| Date of disclosure of the study information | 2018/09/18 |
| Last modified on | 2019/03/26 17:07:57 |
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Basic information
Public title
Optimism, self-efficacy, and stress levels among fourth year nursing students following a brief positive psychology intervention, Tohoku University, Japan
Acronym
Positive psychology intervention study at Tohoku University
Scientific Title
Optimism, self-efficacy, and stress levels among fourth year nursing students following a brief positive psychology intervention, Tohoku University, Japan
Scientific Title:Acronym
Positive psychology intervention study at Tohoku University
Region
| Japan |
Condition
Condition
adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to assess optimism, self-efficacy and stress levels among nursing students before and after a 2-week positive psychology intervention.
Basic objectives2
Others
Basic objectives -Others
Effectiveness of positive psychology methods
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We would like to determine the baseline level of stress among our fourth year nursing students and understand their current coping mechanisms, especially given many of these students had previous exposure to the Great East Japan Earthquake which may have affected their long-term emotional well-being.
Key secondary outcomes
We would like to measure and monitor the change in stress level, optimism, and self-efficacy of the fourth year undergraduate students in School of Nursing after the brief 2-week positive psychology intervention, both immediately and 6 weeks after the intervention to determine longer term efficacy.
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
positive psychology methods
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
| 22 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Fourth year nursing students
2. Enrolled in Tohoku University
3. Aged 20 or older
4. Willingness to participate
Key exclusion criteria
None
Target sample size
69
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Cindy H Chiu |
Organization
School of Health Sciences, Tohoku University Graduate School of Medicine
Division name
Department of Community Health
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
TEL
022-717-7479
cindychiu@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kumiko Nakano |
Organization
School of Health Sciences, Tohoku University Graduate School of Medicine
Division name
Department of Community Health
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
TEL
022-717-7479
Homepage URL
kumiko@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Address
Tel
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
| 2018 | Year | 09 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
From 1 October to 26 November, 2018, we recruited and conducted our positive psychology intervention study on 66 fourth-year nursing students at Tohoku University. After explaining the study purpose and requirements to the study participants, 44 (response rate=66.6%) students enrolled in the study and completed the baseline questionnaire. All enrolled participants were given instructions to do two different positive psychology intervention activities every day for two weeks. Of the 44 enrolled participants, 26 completed the post-intervention questionnaire immediately after the 2-week intervention (retention rate=59.1%), and 23 completed the 6-week follow-up questionnaire (retention rate = 52.3%). Data entry and preliminary analysis has been conducted. However, more detailed analysis is currently ongoing. A follow-up study to promote greater compliance with the positive psychology intervention activities and increase retention rate is currently being explored.
Management information
Registered date
| 2018 | Year | 09 | Month | 18 | Day |
Last modified on
| 2019 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038968
