UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057336 |
|---|---|
| Receipt number | R000065536 |
| Scientific Title | The relationship between hot springs and quality of life - A prospective observational study - |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/19 11:45:18 |
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Basic information
Public title
The relationship between hot springs and quality of life - A prospective observational study -
Acronym
QOL after hot springs
Scientific Title
The relationship between hot springs and quality of life - A prospective observational study -
Scientific Title:Acronym
QOL after hot springs
Region
| Japan |
Condition
Condition
Diseases that can be recorded on the hot spring therapy instructions
Classification by specialty
| Medicine in general | Orthopedics | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary objective: To understand the current state of hot spring therapy instructions
Secondary objective: To verify whether hot spring therapy instructions promote improvement of quality of life through hot spring therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary evaluation item will be to understand the actual state of the hot spring therapy prescription.
Key secondary outcomes
The secondary evaluation item will be to verify whether the hot spring therapy prescription promotes improvement in quality of life through hot spring therapy (to confirm changes after hot spring therapy in eight items, including mental health on the SF-36).
The results of the SF-36 will be examined according to differences in the content of the hot spring therapy.
In addition, improvements to the hot spring therapy prescription will be verified.
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be included in this study:
(1) Those who have been issued a hot spring therapy prescription
(2) Those who fully understand the study plan and are able to give their own consent
(3) Those who are willing to answer the questionnaire
(4) Those who are 18 years of age or older at the time of obtaining consent
Key exclusion criteria
Patients who meet any of the following criteria will not be enrolled in this study.
(1) Poorly controlled hypertension (systolic blood pressure >160mmHg)
(2) History of acute myocardial infarction, deep vein thrombosis, or pulmonary embolism within the past 6 months.
(3) Active and advanced multiple cancers (synchronous multiple cancers and metachronous multiple cancers with a disease-free period of 5 years or less.
However, lesions equivalent to carcinoma in situ in the cervix, stomach, or large intestine that have been determined to be cured by local treatment are not included in active multiple cancers).
(4) Lacking the capacity to give consent, such as dementia.
(5) For any other reason that the study director or co-investigator deems it inappropriate for the patient to participate in this study.
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | SATOSHI |
| Middle name | |
| Last name | YAMASAKI |
Organization
St. Marys Hospital
Division name
Department of Hematology
Zip code
830-8543
Address
422 Tufukuhonmachi, Kurume, Fukuoka
TEL
0942353322
yamas009@gmail.com
Public contact
Name of contact person
| 1st name | SATOSHI |
| Middle name | |
| Last name | YAMASAKI |
Organization
St.Marrys Hospital
Division name
Department of Hematology
Zip code
830-8543
Address
422 Tufukuhonmachi, Kurume, Fukuoka
TEL
0942353322
Homepage URL
yamas009@gmail.com
Sponsor or person
Institute
St. Marys Hospital
Institute
Department
Personal name
SATOSHI YAMASAKI
Funding Source
Organization
Health, Labor, and Welfare Scientific Research Fund Grant
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
St.Marry Hospital
Address
422 Tufukuhonmachi, Kurume, Fukuoka
Tel
0942353322
yamas009@gmail.com
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 | 04 | Month | 01 | 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
| 2024 | Year | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation schedule
1) At the time of registration: SF-36 will be performed from registration until the start of the first spa therapy
2) At the time of final effectiveness evaluation: A second SF-36 will be performed one month after the start of spa therapy
7 days before and after will be allowed
In the event of exacerbation, recurrence, or death, reports will be made at any time.
[Information to be obtained] Age, sex, anonymized spa therapy instructions, SF-36: one month after obtaining consent (final effectiveness evaluation)
Observational study
Subject registration period: April 1, 2025 to March 31, 2026
Total study period: April 1, 2025 to December 31, 2026
Management information
Registered date
| 2025 | Year | 03 | Month | 19 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065536
