UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000038968