UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059041 |
|---|---|
| Receipt number | R000067446 |
| Scientific Title | Effects of bathtub bathing on mental health among Japanese adults: a randomized controlled trial |
| Date of disclosure of the study information | 2025/09/11 |
| Last modified on | 2025/09/03 13:37:17 |
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Basic information
Public title
Effects of bathtub bathing on mental health among Japanese adults: a randomized controlled trial
Acronym
Effects of bathtub bathing on mental health among Japanese adults
Scientific Title
Effects of bathtub bathing on mental health among Japanese adults: a randomized controlled trial
Scientific Title:Acronym
Effects of bathtub bathing on mental health among Japanese adults
Region
| Japan |
Condition
Condition
Mental health
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of an intervention promoting bathtub bathing on mental health among Japanese adults without habitual practice of bathtub bathing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Simplified Japanese version of the WHO-Five Well-being Index (after 4, 8, and 16 weeks)
Key secondary outcomes
Self-related health, Japanese version of the Pittsburgh Sleep Quality Index, Kessler 6-Item Psychological Distress Scale, Japanese version of the three-item loneliness scale, life satisfaction, bathing satisfaction, Feeling of body heating and pleasantness after bathtub bathing, hypertension medication, BMI, body pain, health complaints
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
To instruct participants to engage in home bathtub bathing for at least 5 minutes per day, on at least 4 days per week, over an 8-week period.
Interventions/Control_2
To instruct participants to bathe only by showering at home.
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
Adults aged 18 years or older
Without declines in ADL
Without any disease that restiicts bathing
Without treatments or medications for psychiatric disease
Without treatments or medications for sleep problems
Not currently taking bathtub bathing
Willing to eighter take bathtub bathig at least 4 days in a week or continue bathing only by showering , depending on the random assignment
Not currently bathing outside the home (e.g., at publi bath houses or gyms)
If female, not currently pregnant or breastfeeding
Key exclusion criteria
Individuals aged 17 years or younger
With declines in ADL
With any disease that restiicts bathing
With treatments or medications for psychiatric disease
With treatments or medications for sleep problems
Currently taking bathtub bathing
Not willing to eighter take bathtub bathig at least 4 days in a week or continue bathing only by showering, depending on the random assignment
Currently bathing outside the home (e.g., at publi bath houses or gyms)
If female, currently pregnant or breastfeeding
Target sample size
174
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Harada |
Organization
Kobe University
Division name
Graduate School of Human Development and Environment
Zip code
657-8501
Address
3-11 Tsurukabuto, Nada, Kobe
TEL
078-803-7886
harada@harbor.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Harada |
Organization
Kobe University
Division name
Graduate School of Human Development and Environment
Zip code
657-8501
Address
3-11 Tsurukabuto, Nada, Kobe
TEL
078-803-7886
Homepage URL
harada@harbor.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Kazuhiro Harada
Funding Source
Organization
NORITZ Corporation
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
Graduate School of Human Development and Environment, Kobe University
Address
3-11 Tsurukabuto, Nada, Kobe
Tel
078-803-7905
hudev-soumu@office.kobe-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 | 09 | Month | 11 | 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 | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 07 | 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
| 2025 | Year | 09 | Month | 10 | Day |
Last modified on
| 2025 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067446
