Emotion, ExpressedNCT04044261
Study of Evoked Emotional Responses
A study testing Emotion induction using video in people with Emotion, Expressed, run by Monsoon Design Studio LLC at 1 site in India.
Trial summary
Mental health and emotional awareness are a crucial need of the time. Changing lifestyles, stress, and anxiety are seen more commonly and affect many adults in the United States and other countries. Read more about this study
- Who is it for?
- Ages 18 to 33 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion, Expressed
- What is being tested?
- Emotion induction using video
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2018to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 33 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Bachelor's degree
Who cannot join
- History of neurological disorders
- History of psychological disorders
- Current unemployment
- Major surgery in the past two years
- Chronic disease prescriptions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Evoked Emotional Responses for Supporting Research of EMO-001 Device Using Photoplethysmography, Galvanic Skin Response, and Electrocardiography
Mental health and emotional awareness are a crucial need of the time. Changing lifestyles, stress, and anxiety are seen more commonly and affect many adults in the United States and other countries. Primary aim of this study is to identify the bio-physiological data that is corrected emotions of a person in support of EMO-001 device research.
This study will induce different emotions in the test subjects and collect physiological response signals using Photo Plethysmography (PPG), Galvanic Skin Response (GSR) and Electrocardiogram (ECG) sensors. The sensor data is digitally recorded in a storage bank. The data will be subsequently used to develop supervised and unsupervised classification algorithms.
Read more
Emotional states considered in this study are Anger, Amusement, Neutral, Disgust, Sadness, Scared, Surprise and Thrill. These emotions were induced by showing video clips of three to five minutes to the subjects. For each emotion three clips were shown to each subject. Video clips are sourced from movies, TV shows, and real-life recordings. Subjects evaluated each video clip and classify them into perceived emotional ratings.
Data is processed through a series of filter and transformation methods. The transformed data is used to develop and calibrate algorithms that can identify emotions.
Read the detailed description
Millions of people are affected by mental health conditions every year. Approximately one in five adults in the U.S. experiences at least one mental illness episode every year. Approximately 16 million people have at least one major depressive episode in one year. Researchers have identified that Millennial age-group is at highest risk of developing anxiety, depression, and thoughts of suicide than any other generation. These conditions are attributed by many reasons like increasing competition, less communication, less real-world attachment, work pressure, etc.
Considering the increasing level of issues related to mental health, compelled to think about understanding emotions and associated health impact. Popular methods of emotion detection are by detecting facial expression but to detect real-time emotion, biophysical signals are the best tool as per literature. Also, by considering the future possibility of product form of EMO-001, emotion detection through bio-signals proved to be the correct approach. The intent of the research is to classify the evoked emotions based on bio-signals in support of the product EMO-001 device using photo plethysmography (PPG), Galvanic Skin Response (GSR) and Electrocardiogram (ECG). Identification of emotions from bio-signals, and development of classification algorithm helps the product to identify the emotional state of the person real-time and eventually helps to track the emotional state and suggest an activity which can lift the emotional well being of a person.
Major six emotions, amusement, sad, disgust, scared, surprised, thrill were considered to collect bio signal. Bio signals for the neutral state were also captured to create a baseline for identifying changes in the bio signals with changing emotions.
To find the gender balance in subjects, a similar ratio of male and female considered. Targeting Millennial age-group for this product, we consider people from the age of 18 to 33 years with a minimum bachelor degree qualification and those who are employed. We considered people who understand English and Hindi are considered as subject as video content were in these languages only.
Exploring different methods of emotion elicitation, an audio visual method was considered for this trial, as it is the most effective methods described in different previous literature and through practical scenario. More than 1,000 Video clips from open platform were seen and analysed for five different emotions. Out of which 100 video (20 per emotion) clips were scrutinized by three level checks, selected video clips were also validated by internal blind check to figure out what exact emotion has been elicited from each video. From these identified clips, different set of clips had been prepared. We could identify that video clips are less effective to elicit the anger; hence interaction method was used for it.
Internal validation of data capturing sensors and assembly done to ensure the bio signals obtained are of good quality. For the collection of bio signals, subjects were asked to sit in a proper position, and sensors were placed at particular place of the body.
When the subject was ready for the participation, initially for 30 seconds neutral pictures (e.g. nature sites) were shown to neutralize his/her emotions. After that starting with any of the emotion, three randomly selected videos of a particular emotion from data bank was shown, each followed by a neutral clipping to neutralize the effect of the earlier video. In parallel of videos, the bio-signal data was collected from the sensors. After each video, the subject was asked to fill up a feedback form to rate his emotions. After finishing the signal collection of five different emotions and neutral in between, interaction with subject initiated where the subject was asked about their general background and slowly turned to some sensitive topic which helped to elicit the anger emotion.
The trial had completely non-invasive intervention, where participant need to sit for two hours to watch the videos. Collected data would further be analysed and used for development of emotion classification algorithm.
- Conditions
- Emotion, Expressed
- Being tested
- Emotion induction using video
- Keywords
- Emotional Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion induction using videoProcedure or surgery
Emotions are induced in the test subjects using videos in Hindi and English. Each subject is shown three video clips for each of the emotions.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | Single open-label study arm. All participants are enrolled into this arm. Receives: Procedure: Emotion induction using video |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG V1
Electrocardiogram V1-lead only
Measured: Two hours
SpO2
Blood oxygen concentration using photoplethysmography
Measured: Two hours
GSR
Galvanic skin response
Measured: Two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start1 Nov 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotion, ExpressedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monsoon Design Studio LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Healthark Wellness Solutions LLP
- Responsible party
- Sponsor
- Investigators
- Purav Gandhi, MBBS, Principal investigator, Healthark Wellness Solutions LLPAnshu Shah, PhD, Study director, Healthark Wellness Solutions LLP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044261
- Sponsor's protocol ID
- EMO-001 Phase 0
- Status last verified
- Aug 2019
- First submitted
- 1 Aug 2019
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data collected is individually identifiable and will not be disclosed to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Evoked Emotional Responses for Supporting Research of EMO-001 Device Using Photoplethysmography, Galvanic Skin Response, and Electrocardiography
- ClinicalTrials.gov ID
- NCT04044261
- Acronym / sponsor ID
- EMO-001 Phase 0
- Conditions
- Emotion, Expressed
- Keywords
- Emotional Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Monsoon Design Studio LLCIndustry (pharma, biotech, devices)
- Collaborators
- Healthark Wellness Solutions LLP
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mental health and emotional awareness are a crucial need of the time. Changing lifestyles, stress, and anxiety are seen more commonly and affect many adults in the United States and other countries. Primary aim of this study is to identify the bio-physiological data that is corrected emotions of a person in support of EMO-001 device research.
This study will induce different emotions in the test subjects and collect physiological response signals using Photo Plethysmography (PPG), Galvanic Skin Response (GSR) and Electrocardiogram (ECG) sensors. The sensor data is digitally recorded in a storage bank. The data will be subsequently used to develop supervised and unsupervised classification algorithms.
Emotional states considered in this study are Anger, Amusement, Neutral, Disgust, Sadness, Scared, Surprise and Thrill. These emotions were induced by showing video clips of three to five minutes to the subjects. For each emotion three clips were shown to each subject. Video clips are sourced from movies, TV shows, and real-life recordings. Subjects evaluated each video clip and classify them into perceived emotional ratings.
Data is processed through a series of filter and transformation methods. The transformed data is used to develop and calibrate algorithms that can identify emotions.
Detailed description
Millions of people are affected by mental health conditions every year. Approximately one in five adults in the U.S. experiences at least one mental illness episode every year. Approximately 16 million people have at least one major depressive episode in one year. Researchers have identified that Millennial age-group is at highest risk of developing anxiety, depression, and thoughts of suicide than any other generation. These conditions are attributed by many reasons like increasing competition, less communication, less real-world attachment, work pressure, etc.
Considering the increasing level of issues related to mental health, compelled to think about understanding emotions and associated health impact. Popular methods of emotion detection are by detecting facial expression but to detect real-time emotion, biophysical signals are the best tool as per literature. Also, by considering the future possibility of product form of EMO-001, emotion detection through bio-signals proved to be the correct approach. The intent of the research is to classify the evoked emotions based on bio-signals in support of the product EMO-001 device using photo plethysmography (PPG), Galvanic Skin Response (GSR) and Electrocardiogram (ECG). Identification of emotions from bio-signals, and development of classification algorithm helps the product to identify the emotional state of the person real-time and eventually helps to track the emotional state and suggest an activity which can lift the emotional well being of a person.
Major six emotions, amusement, sad, disgust, scared, surprised, thrill were considered to collect bio signal. Bio signals for the neutral state were also captured to create a baseline for identifying changes in the bio signals with changing emotions.
To find the gender balance in subjects, a similar ratio of male and female considered. Targeting Millennial age-group for this product, we consider people from the age of 18 to 33 years with a minimum bachelor degree qualification and those who are employed. We considered people who understand English and Hindi are considered as subject as video content were in these languages only.
Exploring different methods of emotion elicitation, an audio visual method was considered for this trial, as it is the most effective methods described in different previous literature and through practical scenario. More than 1,000 Video clips from open platform were seen and analysed for five different emotions. Out of which 100 video (20 per emotion) clips were scrutinized by three level checks, selected video clips were also validated by internal blind check to figure out what exact emotion has been elicited from each video. From these identified clips, different set of clips had been prepared. We could identify that video clips are less effective to elicit the anger; hence interaction method was used for it.
Internal validation of data capturing sensors and assembly done to ensure the bio signals obtained are of good quality. For the collection of bio signals, subjects were asked to sit in a proper position, and sensors were placed at particular place of the body.
When the subject was ready for the participation, initially for 30 seconds neutral pictures (e.g. nature sites) were shown to neutralize his/her emotions. After that starting with any of the emotion, three randomly selected videos of a particular emotion from data bank was shown, each followed by a neutral clipping to neutralize the effect of the earlier video. In parallel of videos, the bio-signal data was collected from the sensors. After each video, the subject was asked to fill up a feedback form to rate his emotions. After finishing the signal collection of five different emotions and neutral in between, interaction with subject initiated where the subject was asked about their general background and slowly turned to some sensitive topic which helped to elicit the anger emotion.
The trial had completely non-invasive intervention, where participant need to sit for two hours to watch the videos. Collected data would further be analysed and used for development of emotion classification algorithm.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Procedure: Emotion induction using videoSingle open-label study arm. All participants are enrolled into this arm. |
Who may qualify
- Ages
- 18 to 33 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Bachelor's degree
Key exclusion criteria (5 listed)
- History of neurological disorders
- History of psychological disorders
- Current unemployment
- Major surgery in the past two years
- Chronic disease prescriptions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotion induction using videoEmotions are induced in the test subjects using videos in Hindi and English. Each subject is shown three video clips for each of the emotions. | Procedure or surgery | Study Arm |
Primary outcome
ECG V1
Time frame: Two hours
Electrocardiogram V1-lead only
SpO2
Time frame: Two hours
Blood oxygen concentration using photoplethysmography
GSR
Time frame: Two hours
Galvanic skin response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Individual participant dataSharing planned: No. Data collected is individually identifiable and will not be disclosed to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Purav Gandhi, MBBS principal investigator
Healthark Wellness Solutions LLP
Anshu Shah, PhD study director
Healthark Wellness Solutions LLP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion induction using video in people with Emotion, Expressed, run by Monsoon Design Studio LLC at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG V1 (time frame: Two hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.