UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000035645 |
|---|---|
| Receipt number | R000040597 |
| Scientific Title | psychophysiological changes of elderly people by fine art photo media |
| Date of disclosure of the study information | 2019/01/23 |
| Last modified on | 2021/03/22 14:46:21 |
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Basic information
Public title
psychophysiological changes of elderly people by fine art photo media
Acronym
psychophysiological changes of elderly people by fine art photo media
Scientific Title
psychophysiological changes of elderly people by fine art photo media
Scientific Title:Acronym
psychophysiological changes of elderly people by fine art photo media
Region
| Japan |
Condition
Condition
adeult
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
identify psychophysiological changes by fine art photo media
Basic objectives2
Others
Basic objectives -Others
blood pressure pulse saliva amylase impresion
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Two-dimensional mood scale,
Key secondary outcomes
blood pressure pulse saliva amylase cerebral blood flow
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
viewing of fapm 4min/
viewing of control photo media 4min
Interventions/Control_2
viewing of control photo media 4min/viewing of fapm 4min/
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
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Normal vison
Normal hearing ability
Normal communication ability
Independent of daily life
Key exclusion criteria
not Independence
using pacemaker
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yukari |
| Middle name | |
| Last name | HATTORI |
Organization
Asahikawa medical university
Division name
School of Medicine Department of Nursing
Zip code
078-8510
Address
asahikawa
TEL
0166-68-2111
luna@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Yukari |
| Middle name | |
| Last name | HATTORI |
Organization
Asahikawa medical university
Division name
School of Medicine Department of Nursing
Zip code
078-8510
Address
higashi2 1 1 1 midorigaoka asahikawa
TEL
0166-28-2111
Homepage URL
luna@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa medical university
Institute
Department
Personal name
Funding Source
Organization
Asahikawa medical university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University Research Ethics Committee
Address
Higashi2 Midorigaoka Asahikawa
Tel
0166-68-2187
rs-kk.g@asahikawa-med.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
旭川医科大学（北海道）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 23 | 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
21
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Analysis is delayed
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
| 2018 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 23 | Day |
Last modified on
| 2021 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040597
| 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 |
