- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07555158
Impact of Play Interventions on Stress and Anxiety Using EEG and AI. (ILOS-WEEG)
MEASURING THE IMPACT OF PLAYFUL INTERVENTIONS IN STUDENTS WITH STRESS AND ANXIETY THROUGH THE USE OF ELECTROENCEPHALOGRAPHIC SIGNALS AND ARTIFICIAL INTELLIGENCE
This project will target university students during their exam periods, whether midterms, finals, regular exams, or make-up exams, as this is a time particularly sensitive to academic stress. Participation will be voluntary, with informed consent, and will take place in a space specially prepared to facilitate creative expression and gentle physical movement.
The intervention aims to address this need through the use of brief expressive and somatic techniques, such as guided drawing, body movement, and symbolic reinterpretation. These practices activate the parasympathetic nervous system, promoting states of calm and security that improve cognitive performance.
The intervention lasts 20 minutes in a single session, integrating spontaneous drawing, guided emotional self-reflection, and gentle body exercises. Incorporating the recording of brain activity using electroencephalography (EEG) during the intervention, in a subgroup of participants with the help of the Emotiv Epoc X device, allowing objective observation of the modulation of brain activity in response to the emotional stimulus of the exam and measuring possible changes in electrical patterns associated with states of anxiety, attention and working memory.
Study Overview
Status
Intervention / Treatment
Detailed Description
The following research aims to reduce exam anxiety and stress in university students through an intervention based on playful activities. Participation in the research will be voluntary, requiring informed consent, in a specially prepared space.
The intervention proposes to address this need through the use of brief expressive and somatic techniques, such as guided drawing, body movement, and symbolic reinterpretation. These practices activate the parasympathetic nervous system, promoting states of calm and security that improve cognitive performance.
The intervention lasts 20 minutes in a single session, integrating spontaneous drawing, guided emotional self-reflection, and gentle body exercises.
In addition, brain activity will be recorded using electroencephalography (EEG) during the intervention in a subgroup of participants with the Emotiv Epoc X device. This will allow for the objective observation of the modulation of brain activity in response to the emotional stimulus of the exam and the measurement of possible changes in electrical patterns associated with states of anxiety, attention, and working memory. Accompanied by a brief subjective self-report of perceived anxiety level.
The intervention consists of three steps:
Acceptance and Commitment Therapy (5 minutes): This behavioral therapy aims to increase psychological flexibility. It focuses on accepting negative thoughts and emotions, clarifying goals, and being fully present in the moment (Mindfulness).
This therapy is further carried out in four steps:
- Grounding: Sit upright with your feet flat on the floor and your hands in a comfortable position. Inhale deeply through your nose and then exhale through your mouth (3 times). Mentally repeat, "I am here, in this place, in this moment, and my body is with me."
- Mindful Acceptance: Notice any symptoms: a knot in your stomach, palpitations, sweaty palms. Instead of trying to fight these, accept them as part of the anxiety and stress; simply "let it be." 3. Cognitive defusion involves separating oneself from negative thoughts and understanding them as something external to the person.
4. Reconnecting with goals involves focusing on the "why" of the moment.
Guided drawing (5-10 minutes): This is a form of art-based therapy that uses structured graphic activities to explore and represent emotions or thoughts.
It involves drawing on a sheet of paper a representation of how anxiety is perceived at that moment. The drawing doesn't need to be aesthetically pleasing or "pretty"; simply use lines or shapes that represent the perceived feelings, and use colors if desired.
Afterward, draw something that represents a personal skill that will help you cope with the exam.
Micro-body practice (5 minutes): This involves small somatic interventions that regulate the autonomic nervous system by stimulating the vagus nerve. It includes conscious movement and breathing.
Conscious movements: While standing or sitting, focus your attention on the soles of your feet, gently pressing them into the ground.
Perform a gentle neck stretch by slowly tilting your neck from side to side.
If possible, gently shake your hands and arms for 5-10 seconds.
Focused vagal breathing: Inhale through your nose for 4 seconds, raising your shoulders as you breathe. Hold your breath for 2 seconds, then exhale through your mouth, counting to 6, while lowering your shoulders. Repeat this cycle 3 times.
The effects of these therapies are immediate: rapid reduction of the physiological symptoms of stress and anxiety, increased focus and mental clarity, decreased negative thoughts, and a greater sense of control. If practiced consistently, it has significant and lasting effects: Changes in the structures of the prefrontal cortex, amygdala, and hippocampus that improve psychological flexibility, reducing the likelihood of relapses into anxiety and baseline stress, decreasing emotional reactivity, improving decision-making under pressure, increasing sustained attention, and, in general, enhancing the nervous system's ability to maintain homeostasis.
Emotional changes will be assessed before and after the intervention.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- University students enrolled at the institution where the study will be conducted.
- Ages 18 to 35.
- Students exhibiting moderate levels of stress or anxiety related to academic assessments.
- Students who agree to participate voluntarily and sign the informed consent form.
- Students who are able to attend the intervention session and the neuropsychological and neurophysiological (EEG) assessments.
- Presenting a critical stressful event (an exam)
Exclusion Criteria:
- Students with a prior diagnosis of neurological disorders that may affect brain activity recorded by EEG.
- Students currently undergoing psychiatric treatment or taking medications that alter brain activity.
- Individuals with recent use of psychoactive substances that may interfere with neurophysiological recordings.
- Students who do not complete the initial or final assessments of the study.
- Students who refuse to sign the informed consent form.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Playful intervention.
Participants engage in recreational activities designed to promote emotional regulation before the exam.
|
The intervention lasts approximately 15-20 minutes and consists of three steps: Acceptance and Commitment Therapy (5 minutes): This behavioral therapy aims to increase psychological flexibility. It focuses on accepting negative thoughts and emotions, clarifying goals, and being fully present in the moment (Mindfulness). This therapy is carried out in four steps: Grounding Mindful Acceptance Cognitive defusion Reconnecting with goals Guided drawing (5-10 minutes): It is a form of art-based therapy, where structured graphic activities are used to explore and represent emotions or thoughts. Body Micropractice (5 minutes): These are small somatic interventions that regulate the autonomic nervous system by stimulating the vagus nerve. Conscious movements and breathing.
Other Names:
|
|
No Intervention: waiting list
Participants do not receive the intervention during the study phase, allowing their results to be compared with those of the experimental group.
This group serves as a reference to determine whether the observed changes are truly due to the play-based intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress
Time Frame: Pre-Post intervention / 1 Week
|
The Perceived Stress Scale (PSS-10) is a tool for measuring psychological stress.
A 10-item self-report instrument that measures the degree to which life situations are rated as stressful during the past week.
Each item is scored on a Likert scale from 0 (never) to 4 (very often), with a total range of 0 to 40.
The scale does not have established clinical cut-off points.
|
Pre-Post intervention / 1 Week
|
|
Anxiety
Time Frame: Pre-Post intervention / 1 Week
|
BAI (Beck Anxiety Inventory) An instrument that assesses the presence of anxiety symptoms.
It consists of 21 items, each of which presents a sign or symptom, and the person being evaluated must indicate between four options (None, Slightly, Moderately, and Severely).
The score is obtained by adding up the 21 items, each item being evaluated on a 4-point scale (from 0 to 3).
The total score ranges from 0 to 63 points.
|
Pre-Post intervention / 1 Week
|
|
Neurophysiological measures
Time Frame: During the intervention (20 min)
|
Neurophysiological, electroencephalographic (EEG) recordings will be performed: Each participant will undergo a five minute EEG recording in resting state, previous to any intervention, 128 Hz sampling rate, from 8 ch, EMOTIV Epoc (AF3, AF4, F3, F4, F7, F8, FC5, FC6), with saline solution for conductivity improvement. Offline EEG features frontal alpha-beta proportion change (if any) will be calculated using windowing power spectra transform. Follow-up five minutes, recordings after each intervention session and post-intervention program will be performed as well. |
During the intervention (20 min)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Working memory
Time Frame: Pre-Post intervention / 20-30 min.
|
Working Memory will be measured using the Executive Functions in Higher Education Scale (EFEES), a self-report instrument designed to assess various aspects of executive functions in higher education students.
It consists of 70 items grouped into four factors: organization (F1) with 28 items, self-control (F2) with 14 items, attentional and inhibitory control (F3) with 15 items, and planning and time management (F4) with 10 items, plus 3 items for validity verification.
Each item is answered using a six-point Likert scale, ranging from 0 = Does not describe me at all to 5 = Describes me perfectly.
|
Pre-Post intervention / 20-30 min.
|
|
Decision making
Time Frame: Pre-Post intervention / 20-30 min
|
Decision-making will be measured using the Executive Functions in Higher Education Scale (EFEES), a self-report instrument designed to assess various aspects of executive functions in higher education students.
It consists of 70 items grouped into four factors: organization (F1) with 28 items, self-control (F2) with 14 items, attentional and inhibitory control (F3) with 15 items, and planning and time management (F4) with 10 items, plus 3 items for validity verification.
Each item is answered using a six-point Likert scale, ranging from 0 = Does not describe me at all to 5 = Describes me perfectly.
|
Pre-Post intervention / 20-30 min
|
|
Inhibitory control
Time Frame: Pre-Post intervention / 20-30 min.
|
Inhibitory control will be measured using the Executive Functions in Higher Education Scale (EFEES), a self-report instrument designed to assess various aspects of executive functions in higher education students.
It consists of 70 items grouped into four factors: organization (F1) with 28 items, self-control (F2) with 14 items, attentional and inhibitory control (F3) with 15 items, and planning and time management (F4) with 10 items, plus 3 items for validity verification.
Each item is answered using a six-point Likert scale, ranging from 0 = Does not describe me at all to 5 = Describes me perfectly.
|
Pre-Post intervention / 20-30 min.
|
|
Planning
Time Frame: Pre-Post intervention / 20-30 min
|
Planning will be measured using the Executive Functions in Higher Education Scale (EFEES), a self-report instrument designed to assess various aspects of executive functions in higher education students.
It consists of 70 items grouped into four factors: organization (F1) with 28 items, self-control (F2) with 14 items, attentional and inhibitory control (F3) with 15 items, and planning and time management (F4) with 10 items, plus 3 items for validity verification.
Each item is answered using a six-point Likert scale, ranging from 0 = Does not describe me at all to 5 = Describes me perfectly.
|
Pre-Post intervention / 20-30 min
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 300/2/C/39/26
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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