UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050977 |
|---|---|
| Receipt number | R000058052 |
| Scientific Title | Mutual Effects of Real-Time Visual Feedback Using Internal Physiological Responses during Eating Together Online |
| Date of disclosure of the study information | 2023/05/02 |
| Last modified on | 2023/06/05 18:36:25 |
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Basic information
Public title
Mutual Effects of Real-Time Visual Feedback Using Internal Physiological Responses during Eating Together Online
Acronym
Mutual Effects of Real-Time Visual Feedback Using Internal Physiological Responses during Eating Together Online
Scientific Title
Mutual Effects of Real-Time Visual Feedback Using Internal Physiological Responses during Eating Together Online
Scientific Title:Acronym
Mutual Effects of Real-Time Visual Feedback Using Internal Physiological Responses during Eating Together Online
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the mutual effects of real-time visual feedback during online eating together.
Healthy volunteers were randomly assigned to a group with movable lighting and a group that did not move, whose illuminance fluctuated in conjunction with internal physiological responses during online eating.
Basic objectives2
Others
Basic objectives -Others
To establish online eating with others as a method of gaining a sense of unity to reduce the isolation of inpatients and their families.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in heart rate variability before and after intervention
Key secondary outcomes
Amount of change on the UCLA loneliness scale before and after intervention, correlation coefficient between light illuminance and heart rate variability during intervention, correlation coefficient of heart rate variability between two parties, qualitative data analysis results of questionnaire responses
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Lighting that fluctuates in light intensity in conjunction with heart rate fluctuations moves.
Interventions/Control_2
Lighting that fluctuates in intensity with heart rate fluctuations does not work.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who are 20 years of age or older at the time of obtaining consent (regardless of gender)
Key exclusion criteria
Those who are currently receiving some medication or outpatient treatment, or those who have a mental illness such as cognitive dysfunction that makes it impossible to communicate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
5731010
Address
Shinmachi 2-5-1, Hirakata, Osaka
TEL
072-804-0101
hasuohid@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
5731010
Address
Shinmachi 2-5-1, Hirakata, Osaka
TEL
072-804-0101
Homepage URL
hasuohid@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Hospital Research Ethics Review Committee
Address
Shinmachi 2-3-1, Hirakata, Osaka
Tel
0728040101
hasuohid@hirakata.kmu.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
| 2023 | Year | 05 | Month | 02 | 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
Terminated
Date of protocol fixation
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 02 | Day |
Last modified on
| 2023 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058052
