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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037759
Receipt No. R000043063
Scientific Title Evaluation of a watch type wearable device to release mental tension: A single center randomized controlled trial
Date of disclosure of the study information 2019/10/01
Last modified on 2020/02/20

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Basic information
Public title Evaluation of a watch type wearable device to release mental tension
Acronym Release tension through smartwatch
Scientific Title Evaluation of a watch type wearable device to release mental tension: A single center randomized controlled trial
Scientific Title:Acronym Release tension through smartwatch
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the ability of a watch type wearable device to release mental tension
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Heart rate variebility (HRV) during test
Key secondary outcomes Subjective anxiety scale

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 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Release tension through a watch type wearable device
Interventions/Control_2 Release tension through heart rate variability biofeedback (HRV-BF)
Interventions/Control_3 No release tension
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
65 years-old >
Gender Male and Female
Key inclusion criteria Healthy subjects
Key exclusion criteria Non-heatlhy subjects
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Mizuki
Middle name
Last name Morita
Organization Okayama University
Division name Graduate School of Interdisciplinary Science and Engineering in Health Systems
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-6898
Email mizuki@okayama-u.ac.jp

Public contact
Name of contact person
1st name Mizuki
Middle name
Last name Morita
Organization Okayama University
Division name Graduate School of Interdisciplinary Science and Engineering in Health Systems
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-6898
Homepage URL
Email mizuki@okayama-u.ac.jp

Sponsor
Institute Okayama 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 Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
Tel 086-235-6938
Email mae6605@adm.okayama-u.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
2019 Year 10 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 42
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
2019 Year 09 Month 25 Day
Date of IRB
2019 Year 09 Month 25 Day
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 08 Month 21 Day
Last modified on
2020 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043063

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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