UMIN-CTR Clinical Trial

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

adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tohoku University Graduate School of Medicine

Institute

Department

Personal name

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

09

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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