UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035494 |
|---|---|
| Receipt number | R000040442 |
| Scientific Title | The psychosomatic stress-associated effects of spa-resort tour in elderly people. |
| Date of disclosure of the study information | 2019/06/10 |
| Last modified on | 2019/01/09 14:45:49 |
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Basic information
Public title
The psychosomatic stress-associated effects of spa-resort tour in elderly people.
Acronym
Psychosomatic stress and spa-bathing of the elderly
Scientific Title
The psychosomatic stress-associated effects of spa-resort tour in elderly people.
Scientific Title:Acronym
Psychosomatic stress and spa-bathing of the elderly
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Medicine in general | Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the impact of a short-term spa-resort tour on psychosomatic stress of the elderly
Basic objectives2
Others
Basic objectives -Others
The evaluation of biological effects
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Stress score questionnaire
Key secondary outcomes
Blood pressure
Salivary amylase
Blood test (CRP, serum cortisol)
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
Male and Female
Key inclusion criteria
Healthy people aged 60 years or over
Key exclusion criteria
People in unhealthy condition
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyoki Maeda |
Organization
Kyushu University Beppu Hospital
Division name
The division of internal medicine
Zip code
Address
4546 Tsurumihara, Beppu, Oita, 874-0838, JAPAN
TEL
0977-27-1635(+81-977-27-1635)
maedat@beppu.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toyoki Maeda |
Organization
Kyushu University Beppu Hospital
Division name
The division of internal medicine
Zip code
Address
4546 Tsurumihara, Beppu, Oita, 874-0838, JAPAN
TEL
0977-27-1635(+81-977-27-1635)
Homepage URL
maedat@beppu.kyushu-u.ac.jp
Sponsor or person
Institute
Beppu city
Institute
Department
Personal name
Funding Source
Organization
Beppu city
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 06 | Month | 10 | 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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It was suggested that spa-resort tour was able to reduce psychosomatic stress of the participants.
Management information
Registered date
| 2019 | Year | 01 | Month | 09 | Day |
Last modified on
| 2019 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040442
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
