UMIN-CTR Clinical Trial

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
Email	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
Email	ookura.yoshi@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054365