UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051834 |
|---|---|
| Receipt number | R000059043 |
| Scientific Title | Research on animal-assisted therapy using XR (Extended Reality) technology |
| Date of disclosure of the study information | 2023/08/15 |
| Last modified on | 2023/08/05 03:20:19 |
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Basic information
Public title
Research on animal-assisted therapy using XR (Extended Reality) technology
Acronym
Research on animal-assisted therapy using XR (Extended Reality) technology
Scientific Title
Research on animal-assisted therapy using XR (Extended Reality) technology
Scientific Title:Acronym
Research on animal-assisted therapy using XR (Extended Reality) technology
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the effectiveness of animal-mediated therapy in a virtual space using XR technology.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ECG before and after intervention
Key secondary outcomes
near infrared spectroscopy,Blood pressure, patient demographics (gender, age), and presence of neurological history,Profile of Mood States 2nd Edition(POMS2),Simulator Sickness Questionnaire(SSQ)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intervention using only visual stimuli with XR technology
Interventions/Control_2
Intervention using a combination of visual and tactile stimuli with XR technology
Interventions/Control_3
Intervention to view animal images on a screen
Interventions/Control_4
Do nothing and rest
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Students of International University of Health and Welfare, Narita Campus
Those with no previous neurological history
Able to obtain written consent to participate in the study from the subject of his/her own free will
Age at the time of consent: 18 years or older.lder.
Key exclusion criteria
Those with a neurological history
Patients who have consumed alcohol on the previous day
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | yusuke |
| Middle name | |
| Last name | nishida |
Organization
international university health and welfare
Division name
Narita Health Medical School Department of Physical Therapy
Zip code
286-8686
Address
4-3, Kouzu-no-mori, Narita city, Chiba
TEL
047-620-7717
yuusken@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Mio |
| Middle name | |
| Last name | Miyazaki |
Organization
international university health and welfare
Division name
Graduate School of Health and Welfare, Health Sciences, Physical Therapy, Basic Physical Therapy
Zip code
286-8686
Address
4-3, Kouzu-no-mori, Narita-shi, Chiba
TEL
09078187288
Homepage URL
22s1140@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
not
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
International University of Health and Welfare
Address
4-3, Kouzu-no-mori, Narita-shi, Chiba
Tel
047-620-7717
22s1140@g.iuhw.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 | 08 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 15 | 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 | 08 | Month | 05 | Day |
Last modified on
| 2023 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059043
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
