UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058936 |
|---|---|
| Receipt number | R000067396 |
| Scientific Title | Observational study on oxytocin level variation and well-being effects induced by social interactions in community-dwelling older women |
| Date of disclosure of the study information | 2025/08/30 |
| Last modified on | 2025/08/29 22:31:10 |
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Basic information
Public title
Study on well-being and hormonal changes through intergenerational interaction in older women
Acronym
Older Women's Interaction Study (OWIS)
Scientific Title
Observational study on oxytocin level variation and well-being effects induced by social interactions in community-dwelling older women
Scientific Title:Acronym
Ox-Well Study (Oxytocin and Well-being in Older Women)
Region
| Japan |
Condition
Condition
Psychological well-being in older adults
Classification by specialty
| Geriatrics | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effects of intergenerational interaction on oxytocin secretion and subjective well-being in community-dwelling older women. With the decline of multigenerational households due to urbanization and restrictions on social gatherings during the COVID-19 pandemic, opportunities for intergenerational exchange have decreased, leading to increased loneliness and isolation among older adults, which in turn negatively affects healthy life expectancy. In this study, we will compare direct and remote interactions between postmenopausal women and kindergarten children, and evaluate changes in salivary oxytocin levels, subjective well-being (PWI, NRS), and stress-related indicators including salivary cortisol and autonomic nervous activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in salivary oxytocin concentration before and after social interaction (direct or remote) with children.
Key secondary outcomes
Change in subjective well-being measured by the Personal Wellbeing Index (PWI).
Change in subjective happiness assessed by numerical rating scale (NRS).
Change in salivary cortisol concentration.
Change in autonomic nervous activity (LF/HF ratio measured by rPPG).
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
(1) women aged 60 years or older, and (2) ability to participate in an intergenerational exchange event with kindergarten children as scheduled.
Key exclusion criteria
(1) presence of salivary or pituitary-related disorders, (2) inability to provide saliva samples or complete questionnaires, and (3) inability to leave home for health-related reasons.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Masuyama |
Organization
Okayama University Hospital
Division name
Obstetrics and Gynecology
Zip code
700-8558
Address
Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-223-7151
masuyama@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | shujiro |
| Middle name | |
| Last name | sakata |
Organization
Okayama University Hospital
Division name
Obstetrics and Gynecology
Zip code
700-8558
Address
Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
0862357320
Homepage URL
pg7d7v2v@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
shujiro sakata
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Okayama University Hospital
Address
Clinical Research Support Center, Okayama University Hospital 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
Tel
086-223-7151
mae6605@adm.okayama-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
| 2025 | Year | 08 | Month | 30 | 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
46
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
| 2024 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study targeting community-dwelling women aged 60 years or older. Participants will be assigned to either direct or remote intergenerational interaction with kindergarten children, and changes in salivary oxytocin, salivary cortisol, subjective well-being (PWI, NRS), autonomic nervous activity (LF/HF ratio) will be assessed. Measurements will be conducted at six time points: one week before the interaction, immediately before and after the interaction, and at one and two weeks after the interaction. No randomization or intervention will be applied, and this study is a purely observational comparison.
Management information
Registered date
| 2025 | Year | 08 | Month | 29 | Day |
Last modified on
| 2025 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067396
