UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051253 |
|---|---|
| Receipt number | R000058448 |
| Scientific Title | Prospective Interventional Study Examining the Effectiveness of Virtual-pet Assisted Therapy in Long COVID Patients |
| Date of disclosure of the study information | 2023/06/10 |
| Last modified on | 2024/05/01 15:51:34 |
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Basic information
Public title
Prospective Interventional Study Examining the Effectiveness of Virtual-pet Assisted Therapy in Long COVID Patients
Acronym
Prospective Interventional Study Examining the Effectiveness of Virtual-pet Assisted Therapy in Long COVID Patients
Scientific Title
Prospective Interventional Study Examining the Effectiveness of Virtual-pet Assisted Therapy in Long COVID Patients
Scientific Title:Acronym
Prospective Interventional Study Examining the Effectiveness of Virtual-pet Assisted Therapy in Long COVID Patients
Region
| Japan |
Condition
Condition
Long COVID
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Animal therapy has long been proven to increase happiness and improve loneliness. However, virtual animal therapy has so far proven to be less effective, and since Long-COVID patients often experience some psychological symptoms, we decided to investigate whether virtual animal therapy could improve Long COVID symptoms, considering its feasibility during the COVID-19 epidemic. The feasibility of this project led us to investigate the effect of virtual animal therapy to see if it could improve the symptoms of Long COVID.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Happiness (Satisfaction With Life Scale)
Sleep quality (Athens Sleep Scale)
COVID-19 symptoms
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After consenting, study subjects will participate at the usual intervals of 2, 4, and 6 months between outpatient visits. All visits will be scheduled on the same day as the outpatient visits and will not be for research purposes only. If the outpatient visits are completed during the course of the study, the study will be terminated at that time. After obtaining research consent, a questionnaire will be administered before and after each Virtual Assisted Animal Therapy (VAT) session.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients over 18 years of age attending the Department of General Medicine, Juntendo University Hospital, Juntendo University School of Medicine, with regard to Long COVID.
2. Patients who have received a full explanation of their participation in this study, and who have given written consent of their own free will based on a thorough understanding of the study.
Key exclusion criteria
1. Persons with dizziness to the extent that they have difficulty standing
2. Persons with claustrophobia
3. Persons with communication problems due to cognitive decline, etc.
4. When the principal investigator and principal investigator(s) determine that discontinuation of the study is appropriate for other reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Miyagami |
| Middle name | Yamashita, |
| Last name | Taiju |
Organization
Juntendo University Faculty of Medicine
Division name
Department of General Medicine
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-Ku, Tokyo, Japan
TEL
08050657077
miya0829gami@gmail.com
Public contact
Name of contact person
| 1st name | Miyagami |
| Middle name | |
| Last name | Taiju |
Organization
Juntendo University Faculty of Medicine
Division name
Department of General Medicine
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-Ku, Tokyo, Japan
TEL
08050657077
Homepage URL
miya0829gami@gmail.com
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Faculty of Medicine
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
Ethics Committee of the Faculty of Medicine, Department of Medicine, Soon Chun University
Address
2-1-1, Hongo, Bunkyo-Ku, Tokyo, Japan
Tel
0338133111
tmiyaga@juntendo.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 | 06 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2024 | 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 | 06 | Month | 03 | Day |
Last modified on
| 2024 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058448
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
