UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037759 |
|---|---|
| Receipt number | 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 | 2021/11/27 16:42:39 |
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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
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
mizuki@okayama-u.ac.jp
Sponsor or person
Institute
Okayama 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
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
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
Published
Result
URL related to results and publications
-
Number of participants that the trial has enrolled
42
Results
Our approach eased stress during the exercise itself and the preparation phase of the speech task based on participants' cardiac activity. However, stress was not alleviated during speech delivery.
Results date posted
| 2021 | Year | 11 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy subjects
Participant flow
Notice
Adverse events
Nothing
Outcome measures
Tension (heart rate variability, questionnaire)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2021 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043063
