UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046916 |
|---|---|
| Receipt number | R000053491 |
| Scientific Title | Study of the Influence of Home Robots on Stress Relief Effectiveness in Communication between First-time Meeting People |
| Date of disclosure of the study information | 2022/02/15 |
| Last modified on | 2023/10/31 00:10:19 |
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Basic information
Public title
Study of the Influence of Home Robots on Stress Relief Effectiveness in Communication between First-time Meeting People
Acronym
Study of the Influence of Home Robots on Stress Relief Effectiveness
Scientific Title
Study of the Influence of Home Robots on Stress Relief Effectiveness in Communication between First-time Meeting People
Scientific Title:Acronym
Study of the Influence of Home Robots on Stress Relief Effectiveness
Region
| Japan |
Condition
Condition
Healthy adults
(In the future cancer patients)
Classification by specialty
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify how home robots affect the subjective, physiological and biochemical indicators of healthy people.
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 heart rate variability analysis
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
| Behavior,custom |
Interventions/Control_1
Group of robot intervention
Participants who have never met each other before are divided into groups of two and given 10 minutes to communicate with each other using an ice-breaker technique in the presence of a home robot.
Questionnaires, autonomic nerve balance measurement, and saliva collection will be conducted before and after the communication.
Only one session per group will be conducted.
Interventions/Control_2
Group of without robot intervention (Control)
Participants who have never met each other before will be divided into groups of two and given 10 minutes to communicate with each other using the ice breaking technique.
Questionnaires, autonomic nerve balance measurement, and saliva collection will be conducted before and after the session.
Only one session per group will be conducted.
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects who have no diseases currently under treatment or observation, and who are not taking any medication.
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 who are currently undergoing treatment or observation for a disease.
2) Subjects who need to use drugs for therapeutic purposes for a certain period from the time of obtaining consent to participate in this study.
3) Subjects who have a cardiac pacemaker.
4) Subjects who currently smoke on a daily.
Target sample size
48
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
Nothing
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
The Ethics Review Board for Human Tissue Research/Utilization, Tokyo University of Pharmacy and Life Sciences
Address
Enrollment management and Research Promotion Section, 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 | 02 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
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
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 03 | 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
| 2022 | Year | 02 | Month | 15 | Day |
Last modified on
| 2023 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053491
