UMIN-CTR Clinical Trial

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
Email	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
Email	luna@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa medical university
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040597