UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000058821
Receipt number R000065910
Scientific Title influence of scent on the positive effects induced by physical contact
Date of disclosure of the study information 2025/08/18
Last modified on 2025/08/12 17:13:06

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Basic information

Public title

influence of scent on the positive effects induced by physical contact

Acronym

influence of scent on the positive effects induced by physical contact

Scientific Title

influence of scent on the positive effects induced by physical contact

Scientific Title:Acronym

influence of scent on the positive effects induced by physical contact

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluate the influence of scent inhalation on changes in salivary oxytocin concentrations, heart rate, autonomic nervous function, subjective states (e.g., stress, fatigue, relaxation), and interpersonal emotional responses, all of which are induced by physical contact.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of changes in salivary oxytocin concentrations from before to 16 minutes after physical contact between odorless and scent inhalation conditions.

Key secondary outcomes

Comparison of changes in heart rate from before to after 16 minutes of physical contact between odorless and scent inhalation conditions.
Comparison of changes in autonomic nervous function from before to after 16 minutes of physical contact between odorless and scent inhalation conditions.
Comparison of changes in subjective states from before to after 16 minutes of physical contact between odorless and scent inhalation conditions.
Comparison of changes in interpersonal emotional responses from before to after 16 minutes of physical contact between odorless and scent inhalation conditions.
Comparison of changes in heart rate from before to after 20 minutes of rest between odorless and scent inhalation conditions.
Comparison of changes in autonomic nervous function from before to after 20 minutes of rest between odorless and scent inhalation conditions.
Comparison of changes in subjective states from before to after 20 minutes of rest between odorless and scent inhalation conditions.
Comparison of changes in interpersonal emotional responses from before to after 20 minutes of rest between odorless and scent inhalation conditions.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Test fragrance inhalation (rest 20 min) -> test fragrance inhalation (physical contact 16 min) -> washout (7 days or more) -> odorless air inhalation (rest 20 min) -> odorless air inhalation (physical contact 16 min)

Interventions/Control_2

Odorless air inhalation (rest 20 min) -> odorless air inhalation (physical contact 16 min) -> washout (7 days or more) -> test fragrance inhalation (rest 20 min) -> test fragrance inhalation (physical contact 16 min)

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

49 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Individual who has received sufficient explanation about purpose and content of research, and consenting ability, and who volunteers with his/her free intent and gives written informed consent.
2) Healthy male/female couples aged 18 to under 50 at the time of informed consent.

Key exclusion criteria

1) Individuals with irregular menstrual cycles or postmenopausal
2) Individuals who are pregnant, have a child under 2 years old, or are breastfeeding
3) Individuals with respiratory circulatory, psychiatric, or neurological disorders
4) Individuals who have been diagnosed with hypertension, hypotension, or arrhythmia
5) Individuals who are taking medication (including pills) or supplements
6) Smokers
7) Individuals who find the test fragrance offensive
8) Individuals who have been partners for less than 5 months
9) Individual whom principal investigator judged to be inappropriate as a subject
10) Individuals whose partner falls under 1) to 9)

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Kazunobu
Middle name
Last name Okazaki

Organization

Osaka Metropolitan University

Division name

Center for Health Science Innovation

Zip code

5300011

Address

9th floor, Tower C, North Building, Grand Front Osaka, 3-1, Daishin-cho, Kita-ku, Osaka-shi, Japan

TEL

06-6485-0288

Email

gr-knky-chsi@omu.ac.jp


Public contact

Name of contact person

1st name Eriko
Middle name
Last name Kawai

Organization

Osaka Metropolitan University

Division name

Center for Health Science Innovation

Zip code

5300011

Address

9th floor, Tower C, North Building, Grand Front Osaka, 3-1, Daishin-cho, Kita-ku, Osaka-shi, Japan

TEL

06-6485-0288

Homepage URL


Email

gr-knky-chsi@omu.ac.jp


Sponsor or person

Institute

Osaka Metropolitan University

Institute

Department

Personal name



Funding Source

Organization

MAE Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee, Center for Health Science Innovation

Address

9th floor, Tower C, North Building, Grand Front Osaka, 3-1, Daishin-cho, Kita-ku, Osaka-shi, Japan

Tel

06-6605-2558

Email

gr-knky-chsi@omu.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

2025 Year 08 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

Preinitiation

Date of protocol fixation

2025 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2025 Year 08 Month 01 Day

Last follow-up date

2026 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2025 Year 08 Month 18 Day

Last modified on

2025 Year 08 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065910