UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050246 |
|---|---|
| Receipt number | R000057182 |
| Scientific Title | Verification of effects of the photo walk rally activities combined with hot spring bathing on the sleep quality |
| Date of disclosure of the study information | 2023/02/10 |
| Last modified on | 2023/02/06 17:12:00 |
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Basic information
Public title
Verification of effects of the activities combined with hot spring bathing on the sleep quality
Acronym
Verification of effects of the activities combined with hot spring bathing on the sleep quality
Scientific Title
Verification of effects of the photo walk rally activities combined with hot spring bathing on the sleep quality
Scientific Title:Acronym
Verification of effects of the photo walk rally activities combined with hot spring bathing on the sleep quality
Region
| Japan |
Condition
Condition
sleep disorder
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To survey the effect of a photo walk rally activity combined with hot spring bathing on mood change and sleep quality
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep-related indicators
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
photo walk rally and hot spring bathing
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy males and females
Key exclusion criteria
Persons who are unable to participate in the activities
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Iribe |
Organization
Prefectural university of Kumamoto
Division name
Faculty of Environmental & Symbiotic Sciences
Zip code
862-8502
Address
3-1-100 Tsukide, Higashi-ku, Kumamoto City, Kumamoto Prefecture
TEL
096-321-6727
ykiribe92@pu-kumamoto.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Tribe |
Organization
Prefectural university of Kumamoto
Division name
Faculty of Environmental & Symbiotic Sciences
Zip code
862-8502
Address
3-1-100 Tsukide, Higashi-ku, Kumamoto City, Kumamoto Prefecture
TEL
096-321-6727
Homepage URL
ykiribe92@pu-kumamoto.ac.jp
Sponsor or person
Institute
Prefectural university of Kumamoto
Institute
Department
Personal name
Funding Source
Organization
Prefectural university of Kumamoto
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 Prefectural University Bioethics Review Committee
Address
3-1-100 Tsukide, Higashi-ku, Kumamoto City, Kumamoto Prefecture
Tel
096-321-6727
puk-kenkyu@pu-kumamoto.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
| 2023 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
51
Results
unpublished
Results date posted
| 2023 | Year | 02 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy males and females
Participant flow
unpublished
Adverse events
unpublished
Outcome measures
Physical Activity
Two-dimensional mood scale
Subjective Sleep Sensation (OSA Sleep Questionnaire MA version)
Objective sleep indices
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 06 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057182
