- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06172673
A Database for Emotion Analysis Using Physiological and Psychological Assessment by 40FY
December 28, 2023 updated by: 40FY
A comprehensive study examining the physiological, emotional and psychological aspects of stress among Korean adults
Study Overview
Status
Completed
Detailed Description
A dataset for the analysis of affective states of Korean adults.
Participants' facial and finger videos were recorded using a cell phone camera, while watching six emotion-eliciting video stimuli, each three minutes in length (two of each: neutral, positive, and negative).
Participants were asked to rate their emotion and arousal in terms of arousal and valence levels.
The ECG data were collected using a 1-lead ECG while watching the six emotion-eliciting video stimuli.
Psychological assessments were conducted using self-administered scales measuring psychological status and personality.
Study Type
Observational
Enrollment (Actual)
119
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of
- Research and Development Division, 40FY Inc.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
We recruited Adults between the ages of 19 and 45 who can read fluently in Korean.
All study participants understood the study procedures and provided written informed consent according to the Declaration of Helsinki.
Description
Inclusion Criteria:
- Adults over the age of 19 and under the age of 45.
Exclusion Criteria:
- Participants vulnerable to voluntary consent, such as those who have evidence of intellectual disability or traumatic brain injury
- Participants who have difficulty reading and understanding Korean.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Community dwelling participants
Individuals between the ages of 19 and 45 in South Korea.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Schema Scale
Time Frame: Baseline
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A 35-item questionnaire developed by 40FY for identifying 5-types of maladaptive schema types.
The questionnaire consists of 5-point Likert scale.
The Schema Scale was developed based on schema theory and other psychodynamic theories.
The scale was developed by a certified psychiatrist and 3 clinical psychologists.
A higher score for each factor means that the individual has more severe maladaptive psychological schemas.
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Baseline
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Perceived Stress Scale (PSS)
Time Frame: Baseline
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The PSS is a 10-item scale that measures the perceived stress on a 5-point severity with higher scores indicating more severe perceived stress.
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Baseline
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Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: Baseline
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The CES-D is a 20-item questionnaire that measures depressive symptoms on a 4-point likert scale.
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Baseline
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State-Trait Anxiety Inventory (STAI)
Time Frame: Baseline
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The STAI is a 40-item inventory that measures state and trait anxiety.
Higher score means higher anxiety.
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Baseline
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Beck Anxiety Inventory (BAI)
Time Frame: Baseline
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A 21-item self-inventory on a 4-point likert scale measuring common somatic and cognitive symptoms of anxiety.
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Baseline
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Depression, Anxiety, and Stress Scale (DASS-21)
Time Frame: Baseline
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The DASS-21 scale is an abbreviated version of the 42-item DASS test to measure depression, anxiety, and stress.
It consists of seven items for each domain and is rated on a 4-point Likert scale.
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Baseline
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Self-Assessment Manikin Scale (SAM)
Time Frame: Baseline
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The SAM consists of five pictures, with reference points between the pictures, which are rated on a 9-point scale.
Participants are asked to mark their emotion and arousal on the picture closest to their emotional state.
Six emotion-eliciting video stimuli (2 neutral, 2 negative, and 2 positive) are given, and individuals rate emotion and arousal right after watching each video stimuli.
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Baseline
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Heart-rate variability indices (SDNN, RMSSD, LF, HF)
Time Frame: Baseline
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Measured from 1-lead ECG device.
SDNN is the standard deviation of the NN interval.
It is an indicator of the stability of the cardiovascular system and the responsiveness of the heart rhythm.
RMSSD is the root mean square value of the variation of consecutive NN intervals, which indicates the activity of mainly parasympathetic nerves.
The ECG data were collected by 1-lead ECG while watching 6 emotion-eliciting video stimuli.
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Baseline
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Five Factor Model of Personality Short Form Test (IPIP-NEO-120)
Time Frame: Baseline
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The five factor model of personality is the most widely accepted and used personality based on trait theory.
IPIP-NEO-120 has been developed to reduce the number of questions to 120 while maintaining the structure of 30 sub-facets comprising 5 factors of the 300-item.
The shortened version has been reported to have high validity and reliability.
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Baseline
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Screening for Anxiety Disorders in Adults (SCAARED)
Time Frame: Baseline, Follow-up
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A 44-item, 3-point Likert scale, self-report questionnaire developed as a screening test for anxiety disorders in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
Items from the Screen for Children Anxiety Related Disorders (SCARED) was adapted for the adult version and validated a appropriate for screening for anxiety disorders.
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Baseline, Follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Woori Moon, MD, PhD, 40FY, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 19, 2023
Primary Completion (Actual)
December 8, 2023
Study Completion (Actual)
December 15, 2023
Study Registration Dates
First Submitted
December 7, 2023
First Submitted That Met QC Criteria
December 7, 2023
First Posted (Actual)
December 15, 2023
Study Record Updates
Last Update Posted (Estimated)
January 1, 2024
Last Update Submitted That Met QC Criteria
December 28, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DEAP-40FY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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