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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034180
Receipt No. 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

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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
Email 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
Email kumiko@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038968

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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