UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047682 |
|---|---|
| Receipt number | R000054365 |
| Scientific Title | Psychological effects and changes in autonomic function indices by hugging a stuffed animal |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2022/05/09 10:59:57 |
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Basic information
Public title
Psychological effects and changes in autonomic function indices by hugging a stuffed animal
Acronym
Psychological effects and changes in autonomic function indices by hugging a stuffed animal
Scientific Title
Psychological effects and changes in autonomic function indices by hugging a stuffed animal
Scientific Title:Acronym
Psychological effects and changes in autonomic function indices by hugging a stuffed animal
Region
| Japan |
Condition
Condition
Naturally healthy female college students aged in their 20s
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the psychological effects and changes in autonomic function of hugging a stuffed animal on female college students living a restricted college life due to the spread of COVID-19 infection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HF in heart rate variability analysis before and after intervention
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
hug a stuffed animal
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
| 20 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
Not currently receiving treatment for disease
Female undergraduate student in her third year of medical school at the University of Tokushima School of Medicine
Age is in her 20s
Key exclusion criteria
none
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Tani |
Organization
Tokushima University Hospital
Division name
Department of General Medicine and Primary Care
Zip code
7708503
Address
50 Kuramoto-cho 2, Tokushima, Japan
TEL
088-633-9656
taniken@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Ookura |
Organization
Tokushima University Hospital
Division name
Department of General Medicine and Primary Care
Zip code
7708503
Address
50 Kuramoto-cho 2, Tokushima, Japan
TEL
088-633-9656
Homepage URL
ookura.yoshi@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
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
Clinical Research Center for Developmental Therapeutics, Tokushima University Hospital
Address
2-50-1 Kuramoto-cho, Tokushima 770-8503, Japan
Tel
088-633-9294
088-633-9294
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 | 08 | Month | 01 | 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
| 2022 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | 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 | 05 | Month | 09 | Day |
Last modified on
| 2022 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054365
| Research Plan | |
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| 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 |
