UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047355 |
|---|---|
| Receipt number | R000054013 |
| Scientific Title | Test to confirm the effectiveness of the me-fullness application in promoting well-being |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2022/04/01 16:26:51 |
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Basic information
Public title
Test to confirm the effectiveness of the me-fullness application in promoting well-being
Acronym
Test to confirm the effectiveness of the me-fullness application in promoting well-being
Scientific Title
Test to confirm the effectiveness of the me-fullness application in promoting well-being
Scientific Title:Acronym
Test to confirm the effectiveness of the me-fullness application in promoting well-being
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to grasp the actual situation of stress and mental health problems of local government employees in the areas affected by the Great East Japan Earthquake and to establish the effectiveness of the me-fullness application for improving mental health.
Basic objectives2
Others
Basic objectives -Others
We will also examine whether the me-fullness application is effective for local government employees' anxiety about possible future disasters and the stress of communicating this anxiety to local government residents.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Before and after one month of use of the me-fullness application, psychological test scores (Chalder Fatigue Scale, Athens Insomnia Scale, Japanese version of PANAS, Four Factors of Happiness, Mental Resilience Scale, Depression Anxiety Stress Scale (DASS-21), PTGI-SF-J: Japanese version - post traumatic stress) were administered to the subjects. (Growth Scale Short Version, Imposter Phenomenon Checklist) to identify psychological states.
Key secondary outcomes
Before and after using the me-fullness application for one month, study participants will be interviewed to determine changes.
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
| Device,equipment | Behavior,custom |
Interventions/Control_1
The intervention will be conducted using me-fullness, an application created by POLA Chemical Industries, Inc. using knowledge and data accumulated on facial information to support people who are unable to change their moods due to fatigue or stress for a month.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Male and female employees of Shichigahama Town Hall.
Those who have indicated their willingness to participate in the study and have agreed to participate after understanding the explanation.
Key exclusion criteria
1) Medications that may affect the study (fatigue, stress, drugs that claim to improve sleep) Those who are taking or using the drug on a daily basis.
2) Those with hearing problems that interfere with daily life
3) Those participating in other interventional trials
4) Any other person deemed inappropriate by the study investigator.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Okuyama |
Organization
Tohoku University Hospital
Division name
Department of Physical Medicine and Rehabilitation
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7338
junko.okuyama@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Okuyama |
Organization
Tohoku University Hospital
Division name
Department of Physical Medicine and Rehabilitation
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
TEL
0227177338
Homepage URL
junko.okuyama@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Department of Rehabilitation, Tohoku University Hospital
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan
Tel
0227177338
junko.okuyama@med.tohoku.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
| 2022 | Year | 04 | 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 | 03 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 03 | 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 | 04 | Month | 01 | Day |
Last modified on
| 2022 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054013
