UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046646
Receipt number R000053207
Scientific Title Effects of Remote Learning on EEG Activity
Date of disclosure of the study information 2022/03/01
Last modified on 2023/02/04 15:51:55

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Basic information

Public title

Effects of Remote Learning on EEG Activity

Acronym

Effects of Remote Learning on EEG Activity

Scientific Title

Effects of Remote Learning on EEG Activity

Scientific Title:Acronym

Effects of Remote Learning on EEG Activity

Region

Japan


Condition

Condition

Healthy nursing students

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Determine the EEG activity and heartbeats change of the nursing students on remote learning and examine the stress of the student by remote learning.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

EEG activity, heartbeats change and the change of the mental and physical condition from the beginning to the end of the remote learning.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

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

Taking online classes

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

First-year students in the basic nursing education program.Subjects with no history of brain disease, heart disease, syncope, or allergies.

Key exclusion criteria

Subjects with history of brain disease, heart disease, syncope, or allergies.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Chiharu
Middle name
Last name Matsumoto

Organization

Kumamoto University

Division name

Fuculty of Life Sciences; Fundamental Nursing

Zip code

862-0976

Address

4-24-1 Kuhonji, Chuo-ku, Kumamoto 862-0976 JAPAN

TEL

096-373-5517

Email

matsu-c@kumamoto-u.ac.jp


Public contact

Name of contact person

1st name Chiharu
Middle name
Last name Matsumoto

Organization

Kumamoto University

Division name

Fuculty of Life Sciences; Fundamental Nursing

Zip code

862-0976

Address

4-24-1 Kuhonji, Chuo-ku, Kumamoto 862-0976 JAPAN

TEL

096-373-5517

Homepage URL


Email

matsu-c@kumamoto-u.ac.jp


Sponsor or person

Institute

Kumamoto University

Institute

Department

Personal name



Funding Source

Organization

Kumamoto University

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

Kumamoto University

Address

4-24-1 Kuhonji, Chuo-ku, Kumamoto 862-0976 JAPAN

Tel

096-373-5517

Email

matsu-c@kumamoto-u.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

2022 Year 03 Month 01 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

2022 Year 01 Month 14 Day

Date of IRB

2022 Year 01 Month 25 Day

Anticipated trial start date

2022 Year 02 Month 01 Day

Last follow-up date

2023 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

2022 Year 01 Month 14 Day

Last modified on

2023 Year 02 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053207