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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

India1 site
  • Healthark Wellness Solutions LLP

    Ahmedabad, Gujarat, 380015

Other trials in India

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.

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 groups in NCT04044261
Study groupRoleWhat they receive
Study ArmExperimentalSingle 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.

  1. ECG V1

    Electrocardiogram V1-lead only

    Measured: Two hours

  2. SpO2

    Blood oxygen concentration using photoplethysmography

    Measured: Two hours

  3. 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.

  1. First posted5 Aug 2019
  2. Study start1 Nov 2018
  3. Primary completion30 Apr 2019
  4. Study completion30 Apr 2019

Resources

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)
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.

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.

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