UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046098 |
|---|---|
| Receipt number | R000052586 |
| Scientific Title | A Preliminary Study on the Application of Family-type Robot (LOVOT) in Medical and Clinical Practice |
| Date of disclosure of the study information | 2021/11/17 |
| Last modified on | 2024/05/21 15:58:29 |
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Basic information
Public title
A Preliminary Study on the Application of Family-type Robot (LOVOT) in Medical and Clinical Practice
Acronym
A Preliminary Study on the Application of Family-type Robot (LOVOT) in Medical and Clinical Practice
Scientific Title
A Preliminary Study on the Application of Family-type Robot (LOVOT) in Medical and Clinical Practice
Scientific Title:Acronym
A Preliminary Study on the Application of Family-type Robot (LOVOT) in Medical and Clinical Practice
Region
| Japan |
Condition
Condition
Pediatric patients, rehabilitation patients, oncology-related patients(obstetrics and gynecology, breast surgery, medical oncology), nurses
Classification by specialty
| Hematology and clinical oncology | Breast surgery | Obstetrics and Gynecology |
| Pediatrics | Rehabilitation medicine | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this project is to pursue the new possibilities of family-type robots in the medical and healthcare fields and to establish new relationships between humans and robots, such as patients, their families, and healthcare professionals. This study is to conduct a preliminary investigation for this purpose.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
To evaluate the change in the state of mind before and after the introduction of LOVOT to patients and their parents or medical staff.
To evaluate behavioral changes on the video for rehabilitation patients.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Rehabilitation patients will be monitored for a total of two weeks, one week each with and without LOVOT. All other patients and health care providers will be assessed for one week with LOVOT.
Rehabilitation patients will be monitored for a total of two weeks, one week each with and without LOVOT. All other patients and health care providers will be tested for 1 week with LOVOT.
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
| 5 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients were selected by the attending physician based on their disease and condition.
Key exclusion criteria
The patients who are unsuitable by attending physician in consideration of their disease and condition.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Kobayashi |
Organization
St. Marianna University School of Medicine
Division name
Medical Information and Communication Technology Research
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-city, kanagawa-prefecture, Japan.
TEL
044-977-8111
yasukoba@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Kobayashi |
Organization
St. Marianna University School of Medicine
Division name
Medical Information and Communication Technology Research
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-city, kanagawa-prefecture, Japan.
TEL
044-977-8111
Homepage URL
yasukoba@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Medical Information and Communication Technology Research
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Medical Information and Communication Technology Research
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
St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-city, kanagawa-prefecture, Japan.
Tel
044-977-8111
yasukoba@marianna-u.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
| 2021 | Year | 11 | Month | 17 | 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
| 2020 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 20 | 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
| 2021 | Year | 11 | Month | 17 | Day |
Last modified on
| 2024 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052586
