UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050991 |
|---|---|
| Receipt number | R000058124 |
| Scientific Title | Visual feedback with heart rate variability lights during online eating together with patients with cancer and their family |
| Date of disclosure of the study information | 2023/05/05 |
| Last modified on | 2023/11/04 09:04:28 |
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Basic information
Public title
Visual feedback with heart rate variability lights during online eating together with patients with cancer and their family
Acronym
Heart rate variability lights during online eating together
Scientific Title
Visual feedback with heart rate variability lights during online eating together with patients with cancer and their family
Scientific Title:Acronym
Heart rate variability lights during online eating together
Region
| Japan |
Condition
Condition
Loneliness of patients with cancer
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Randomized controlled study of the mutual effect of heart rate variability lights on patients with cancer and their families during eating together online.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in heart rate variability score
Key secondary outcomes
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use of heart rate variability lights during eating together online
Interventions/Control_2
No use of heart rate variability lights during eating together online
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inpatient patients with cancer and their families
Key exclusion criteria
1) ECOG PS 4 or higher
2) Those who are prohibited from consuming cookies and tea due to dietary restrictions
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Department of Psychosomatic Medicine, Kansai Medical University
Division name
Department of Psychosomatic Medicine, Kansai Medical University
Zip code
573-1010
Address
2-5-1-505 Shinmachi, Hirakata, Osaka 573-1010, Japan
TEL
0728040101
h.hasuo7@gmail.com
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Department of Psychosomatic Medicine, Kansai Medical University
Division name
Department of Psychosomatic Medicine, Kansai Medical University
Zip code
5731010
Address
2-5-1-505 Shinmachi, Hirakata, Osaka 573-1010, Japan
TEL
0728040101
Homepage URL
h.hasuo7@gmail.com
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
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
Kansai Medical University
Address
2-5-1-505 Shinmachi, Hirakata, Osaka 573-1010, Japan
Tel
0728040101
h.hasuo7@gmail.com
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 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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 | 05 | Day |
Last modified on
| 2023 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058124
