UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053524 |
|---|---|
| Receipt number | R000060864 |
| Scientific Title | Effects of Reminiscence Using Maps Application on Feeling and Biological Reactions of Community-Dwelling Elderly |
| Date of disclosure of the study information | 2024/02/05 |
| Last modified on | 2024/02/02 16:31:40 |
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Basic information
Public title
Effects of Reminiscence Using Maps Application on Feeling and Biological Reactions of Community-Dwelling Elderly
Acronym
Effects of Reminiscence Using Maps Application on Feeling and Biological Reactions of Community-Dwelling Elderly
Scientific Title
Effects of Reminiscence Using Maps Application on Feeling and Biological Reactions of Community-Dwelling Elderly
Scientific Title:Acronym
Effects of Reminiscence Using Maps Application on Feeling and Biological Reactions of Community-Dwelling Elderly
Region
| Japan |
Condition
Condition
The healthy Elderly Target population is dementia
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of reminiscence using maps application in VR space on feeling and biological reactions of community-dwelling elderly to reveal the potential for dementia prevention
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG of baseline period, before and after each reminiscence, and one month after the completion of all six reminiscence
Key secondary outcomes
For biological reactions, "EEG data", "MCI probability rate",and, "Heart rate variability (sympathetic and parasympathetic nervous system activity, autonomic nervous system activity, stress index, and on a scale of one to three about stress and anxiety)" will be collected. For feeling, "Geriatric Depression Scale-Short Version-Japanese(GDS15)", "Reliability and validity of Subjective Well-Being", "On a scale of one to ten about the positive feeling", and audio data.
"Geriatric Depression Scale-Short Version-Japanese", and "Reliability and validity of Subjective Well-Being" will be collected during baseline period, after the sixth reminiscence, and one month after the completion of all six reminiscence. "On a scale of one to ten about the positive feeling", "MCI probability rate", and "Heart rate variability (sympathetic and parasympathetic nervous system activity, autonomic nervous system activity, stress index, and on a scale of one to three about stress and anxiety)" will be collected during baseline period, before and after each reminiscence, and one month after the completion of all six reminiscence. Audio data will be collected during reminiscence, and roundtable one month after the completion of all six reminiscence.
Factors that threaten internal validity will be collected through preliminary and posteriori survey. Details of preliminary survey is age, gender, whether or not the subjects live, the Tokyo Metropolitan Institute of Gerontology index of competence, dementia prevention activities started within 2 months, daily vision, and memorable places.
Details of posteriori survey is major life events during the period of the study, and impressions and questions about this study.
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
Using Oculus Quest made by Meta and Google earth's Street view to tour around the subject's memorable places. The locations to visit are decided while discussing with subjects after confirming that the location exists on the map application based on the preliminary survey. The reminiscence is conducted once a week for a total of approximately 40 minutes per session, every other week for a total of six sessions.
One month after the completion of all six reminiscence, a roundtable will be held focusing on the change in feelings (visited places, situations that invoked positive feelings, and specific feelings at that time) through the reminiscence. Each group of about 6 people will be discussed freely about the change in feelings through their reminiscence.
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
| 70 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The healthy elderly who belong to an organization of elderly reside in the area surrounding Nara City.
Key exclusion criteria
Those who have been diagnosed with dementia.
At the information session, those who are slurred in their speech, unable to respond or cannot understand the promised time.
Those who have suffered from cervical/spinal diseases or epilepsy.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ayame |
| Middle name | |
| Last name | Katayama |
Organization
Naragakuen University
Division name
Graduate School of Nursing
Zip code
631-0003
Address
3-15-1, Nakatomigaoka, Nara City, Nara, Japan
TEL
0742959800
h2351102@nara-su.ac.jp
Public contact
Name of contact person
| 1st name | Ayame |
| Middle name | |
| Last name | Katayama |
Organization
Naragakuen University
Division name
Graduate School of Nursing
Zip code
631-0003
Address
3-15-1, Nakatomigaoka, Nara City, Nara, Japan
TEL
0742959800
Homepage URL
h2351102@nara-su.ac.jp
Sponsor or person
Institute
Naragakuen University
Institute
Department
Personal name
Katayama Ayame
Funding Source
Organization
self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Naragakuen University
Address
3-15-1, Nakatomigaoka, Nara City, Nara, Japan
Tel
0742959800
h2351102@nara-su.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
| 2024 | Year | 02 | Month | 05 | 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
| 2023 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 02 | Day |
Last modified on
| 2024 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060864
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| Registered date | File name |
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