UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053316 |
|---|---|
| Receipt number | R000060858 |
| Scientific Title | Verification of the availability of OpenFace and complexion measurement as a distress assessment. |
| Date of disclosure of the study information | 2024/01/11 |
| Last modified on | 2024/01/10 21:03:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Verification of the availability of OpenFace and complexion measurement as a distress assessment.
Acronym
Use of OpenFace and complexion measurement as Distress Assessment
Scientific Title
Verification of the availability of OpenFace and complexion measurement as a distress assessment.
Scientific Title:Acronym
Verification of the availability of OpenFace and complexion measurement as a distress assessment.
Region
| Japan |
Condition
Condition
Healthy adults.
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will examine the possibility of using OpenFace, a facial expression analysis tool, as a distress assessment. We will also verify the accuracy and precision of the method to quantify complexion by RGB (Red/Green/Blue) values of images.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Various parameters of facial muscle movements (Action Unit: AU) measured by OpenFace
Key secondary outcomes
1.Evaluation of subjective pain sensation using Visual Analog Scale (VAS) and Face Scale.
2.Measurement of RGB values of the participant's face using the color chart as a reference value.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Behavior,custom |
Interventions/Control_1
The participant's non-dominant hand is immersed in cold water . One set is 15 seconds, with 30 seconds between sets, for a total of three sets to obtain the AU, VAS, and RGB values.
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
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Niigata University students between the ages of 18 and 29 who agree with the main purpose of this study
Key exclusion criteria
Those with heart or circulatory problems (especially Raynaud's syndrome), blood pressure, diabetes, anemia, epilepsy, etc.
Those with serious injuries.
Those who have trauma or frostbite to the non-dominant hand.
Those who are taking medication for high blood pressure.
Those who are prone to frostbite.
Those who have difficulty in adjusting their bangs with hairpins so that their eyebrows show.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Sayuri |
| Middle name | |
| Last name | Sakai |
Organization
Niigata University
Division name
Graduate school of health sciences
Zip code
9518518
Address
746 Asahimachi dori2, Chuo-ku, Niigata city, Niigata Prefecture
TEL
+81252270941
sakai@clg.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Sayuri |
| Middle name | |
| Last name | Sakai |
Organization
Niigata University
Division name
Graduate school of health sciences
Zip code
9518518
Address
746 Asahimachi dori2, Chuo-ku, Niigata city, Niigata Prefecture
TEL
+81252270941
Homepage URL
sakai@clg.niigata-u.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University
Address
757 Ichibancho, Asahimachi-dori, Chuo Ward, Niigata City 951-8510
Tel
+8525-227-2625
ethics@adm.niigata-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
| 2024 | Year | 01 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 10 | 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
| 2024 | Year | 01 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060858
