UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047594 |
|---|---|
| Receipt number | R000054274 |
| Scientific Title | Study on the effects of long-term intervention of a home robots on stress reduction. |
| Date of disclosure of the study information | 2022/04/26 |
| Last modified on | 2024/05/08 00:12:45 |
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Basic information
Public title
Study on the effects of long-term intervention of a home robots on stress reduction.
Acronym
Study on long-term stress-relieving effects of a home robots
Scientific Title
Study on the effects of long-term intervention of a home robots on stress reduction.
Scientific Title:Acronym
Study on long-term stress-relieving effects of a home robots
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine what long-term effects family-type robots have on subjective, physiological and biochemical indices of stress in healthy individuals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analog Scale (VAS) values of subjective mental changes
(I feel irritated, I have worries, I feel tense, I feel nervous, I have anxiety, I am depressed.)
Key secondary outcomes
1) Concentration of physiologically active substances in saliva
(oxytocin, secretory immunoglobulin A (s-IgA))
2) Autonomic balance index based on pulse wave (heart rate) variability analysis
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Subjects spend 15 minutes with the home robot "LOVOT(R)" (GROOVE X Co., Ltd.) before bedtime every day for six weeks. Saliva sampling and autonomic nerve balance measurement based on pulse wave fluctuations using the acceleration pulse wave measuring device "TAS9 VIWE RW" (YKC Co., Ltd.) are conducted three times a week (Monday, Wednesday, Friday), and a questionnaire survey on mental state using the Visual Analog Scale (VAS) is conducted once a week (Wednesday).
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects aged 18 to 65 at the time of consent.
2) Subjects who have been informed of the contents of this study and have confirmed their consent in the consent form.
Key exclusion criteria
1) Subjects with a diagnosis of arrhythmia
2) Subjects who have a cardiac pacemaker.
3) Subjects who currently smoke on a daily.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Sadahiko |
| Middle name | |
| Last name | Shimoeda |
Organization
Tokyo University of Pharmacy and Life Sciences
Division name
Department of Pharmacy Pharmaceutical Care and Sciences
Zip code
192-0392
Address
1432-1 Horinouchi, Hachioji, Tokyo
TEL
042-676-6697
shimoeda@toyaku.ac.jp
Public contact
Name of contact person
| 1st name | Sadahiko |
| Middle name | |
| Last name | Shimoeda |
Organization
Tokyo University of Pharmacy and Life Sciences
Division name
Department of Pharmacy Pharmaceutical Care and Sciences
Zip code
192-0392
Address
1432-1 Horinouchi, Hachioji, Tokyo
TEL
042-676-6697
Homepage URL
shimoeda@toyaku.ac.jp
Sponsor or person
Institute
Tokyo University of Pharmacy and Life Sciences
Institute
Department
Personal name
Funding Source
Organization
None
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
The Ethics Review Board for Human Tissue Research/Utilization, Tokyo University of Pharmacy and Life Sciences
Address
Tokyo University of Pharmacy and Life Sciences 1432-1 Horinouchi, Hachioji, Tokyo
Tel
042-676-5349
rinri-office-ml@toyaku.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
| 2022 | Year | 04 | Month | 26 | 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
0
Results
The study was discontinued due to lack of approval by the Ethics Board.
Results date posted
| 2024 | Year | 05 | Month | 08 | Day |
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
| 2022 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 05 | 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
The study was discontinued due to lack of approval by the Ethics Board.
Therefore, the date of approval by the Ethics Committee is the same as the date of protocol finalisation for convenience.
Management information
Registered date
| 2022 | Year | 04 | Month | 26 | Day |
Last modified on
| 2024 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054274
