UMIN-ICDS Clinical Trial

Public title

The Relationship Between Well-Being and Psychophysiological Functions While Performing Task

Acronym

Relationship Between Well-Being and Psychophysiological Functions

Scientific Title

The Relationship Between Well-Being and Psychophysiological Functions During Task Performance

Scientific Title:Acronym

Relationship Between Well-Being and Psychophysiological Functions

Region

Japan

Condition

Healthy Adults.
This research aims to clarify the characteristics of physical and mental functions in individuals with a high level of "well-being," a concept of psychological health. Therefore, its application to individuals with illnesses is not currently planned.

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to clarify the relationship between well-being and the regulation of psychological and physical functions involved in task performance.

Basic objectives2

Others

Basic objectives -Others

A psychological study examining the relationship between well-being and psychological and physiological functions during and prior to task performance

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Primary outcomes

Primary Outcome:Differences in endocrine activity across multiple days prior to task performance as a function of levels of well-being.
Assessment Method:Participants are instructed to self-collect saliva samples 7 days, 3 days, and 1 day prior to the task performance day, on which they visit the laboratory to perform the task. Endocrine activity is assessed by measuring salivary cortisol concentrations, which serve as an index of endocrine system activity.

Key secondary outcomes

Secondary Outcome 1: Differences in immune system activity across multiple days prior to task performance according to levels of well-being.
Assessment Method: Participants self-collect saliva samples 7 days, 3 days, and 1 day prior to the task performance day. Immune system activity is assessed by measuring salivary interleukin-6 (IL-6) concentrations.

Secondary Outcome 2: Differences in central nervous system activity during task performance according to levels of well-being.
Assessment Method: Electroencephalography (EEG) is recorded on the task performance day and used as an index of central nervous system activity.

Secondary Outcome 3: Differences in peripheral nervous system activity during task performance according to levels of well-being.
Assessment Method: Electrocardiography and impedance cardiography are recorded on the task performance day. Heart rate and pre-ejection period are used as indices of peripheral nervous system activity.

Secondary Outcome 4: Differences in endocrine system activity during task performance according to levels of well-being.
Assessment Method: On the task performance day, participants self-collect saliva samples eight times. Endocrine system activity is assessed using salivary cortisol concentrations.

Secondary Outcome 5: Differences in immune system activity during task performance according to levels of well-being.
Assessment Method: Using the same saliva samples collected on the task performance day, salivary IL-6 concentrations are measured as indices of immune system activity.

Secondary Outcome 6: Differences in mood during task performance according to levels of well-being.
Assessment Method: Immediately after task completion, participants complete a self-report questionnaire assessing mood during task performance, and the obtained scores are used as indices of mood.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

40

years-old

>=

Gender

Male

Key inclusion criteria

1: Individuals who are able to provide written informed consent to participate in the study of their own free will.
2: Individuals who are able to travel to the experimental site without using public transportation, in order to avoid contact with an unspecified number of people and reduce the risk of infectious disease exposure.
3: Individuals who are aged between 20 and 40 years at the time of obtaining informed consent.
4: Individuals whose biological sex is male, in order to minimize the potential influence of hormonal fluctuations associated with the menstrual cycle.
5: Individuals who self-report having regular sleep-wake schedules (i.e., an established rhythm of waking in the morning and sleeping at night).
6: Individuals who self-report having regular meal times.
7: Individuals with normal visual function, defined as a visual acuity of 0.7 or higher (with correction by glasses or contact lenses if necessary), in order to appropriately perceive the visual stimuli presented in the experiment.
8: Individuals with normal hearing ability that does not interfere with daily conversation, in order to appropriately perceive the auditory stimuli presented in the experiment.
9: Individuals who have no difficulty with or resistance to the attachment of electrodes for physiological signal measurements on the head, face, neck, flanks, chest, abdomen, ears, and other body sites.
10: Individuals who are able to participate while wearing clothing consisting of separate upper and lower garments, to allow the attachment of multiple electrodes to the body.
11: Individuals who have no resistance to saliva collection.
12: Individuals who are able to refrain from tooth brushing, eating or drinking, smoking, and vigorous physical activity for at least one hour prior to saliva collection.
13: Individuals who do not participate in any other experiments during the period of participation in this study.

Key exclusion criteria

1: Individuals who are currently taking medications that may affect the activity of the central nervous system, peripheral nervous system, endocrine system, or immune system.
2: Individuals who have current diseases or a medical history of diseases affecting organs that are considered to influence the activity of the central nervous system, peripheral nervous system, endocrine system, or immune system, including the brain, heart, blood vessels, thymus, lymph nodes, bone marrow, spleen, liver, and adrenal glands.
3: Individuals with a body mass index (BMI) of 25.0 or higher.
4: Individuals with a body mass index (BMI) of 18.5 or lower.

Target sample size

70

Name of lead principal investigator

1st name	Motohiro
Middle name
Last name	Kimura

Organization

National Institute of Advanced Industrial Science and Technology

Division name

Human Informatics and Interaction Research Institute

Zip code

305-8566

Address

AIST Tsukuba Central 6, 1-1-1 Higashi, Tsukuba, Ibaraki 305-8566, JAPAN

TEL

029-861-6001

Email

m.kimura@aist.go.jp

Name of contact person

1st name	Motohiro
Middle name
Last name	Kimura

Organization

National Institute of Advanced Industrial Science and Technology

Division name

Human Informatics and Interaction Research Institute

Zip code

305-8566

Address

AIST Tsukuba Central 6, 1-1-1 Higashi, Tsukuba, Ibaraki 305-8566, JAPAN

TEL

029-861-6001

Homepage URL

Email

m.kimura@aist.go.jp

Institute

National Institute of Advanced Industrial Science and Technology

Institute

Department

Personal name

Organization

Toyota Motor Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

AIST Tsukuba, Committee on Bioethics

Address

1-1-1 Higashi, Tsukuba, Ibaraki 305-8561 Japan

Tel

029-861-2000

Email

safe-life-ml@aist.go.jp

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

2026

Year

04

Month

20

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

Open public recruiting

Date of protocol fixation

2025

Year

11

Month

26

Day

Date of IRB

2025

Year

11

Month

26

Day

Anticipated trial start date

2025

Year

11

Month

27

Day

Last follow-up date

2027

Year

01

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is an observational study aimed at examining the relationship between well-being and psychological and physiological functions, employing a single-group, repeated-measures design.

Participants are recruited through postings and research cooperation requests within the research institution. The recruitment period is planned to run from November 2025 to January 2027.

Psychological measures include well-being and mood during task performance, assessed using self-report questionnaires. Physiological measures include salivary cortisol and interleukin-6 (IL-6) concentrations collected 7 days, 3 days, and 1 day prior to the task performance day, as well as on the task performance day. In addition, electroencephalography (EEG), electrocardiography (ECG), and impedance cardiography are recorded on the task performance day and used as indices of central nervous system, peripheral nervous system, endocrine system, and immune system activity.

Registered date

2026

Year

04

Month

20

Day

Last modified on

2026

Year

04

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070166