AnxietyILOS-WEEGNCT07555158
Impact of Play Interventions on Stress and Anxiety Using EEG and AI.
A study testing playful intervention in people with Anxiety and Stress, run by Universidad Autonoma de Baja California.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- What is being tested?
- playful intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2026to 15 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- 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.
- Being tested
- playful intervention
- Keywords
- Stress, Anxiety, university students, playful activities, academic performance
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
playful interventionBehavioural
Also called Acceptance and Commitment Therapy, Guided drawing, Body micropractice
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.
| Study group | Role | What they receive |
|---|---|---|
| Playful intervention. | Experimental | Participants engage in recreational activities designed to promote emotional regulation before the exam. Receives: Behavioral: playful intervention |
| waiting list | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Stress
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.
Measured: Pre-Post intervention / 1 Week
Anxiety
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.
Measured: Pre-Post intervention / 1 Week
Neurophysiological measures
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.
Measured: During the intervention (20 min)
Secondary outcomes (4)
Working memory
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.
Measured: Pre-Post intervention / 20-30 min.
Decision making
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.
Measured: Pre-Post intervention / 20-30 min
Inhibitory control
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.
Measured: Pre-Post intervention / 20-30 min.
Planning
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.
Measured: Pre-Post intervention / 20-30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Baja California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilberto Galindo, Universidad Autonoma de Baja California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555158
- Sponsor's protocol ID
- 300/2/C/39/26
- Acronym
- ILOS-WEEG
- Status last verified
- Jun 2025
- First submitted
- 21 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEASURING THE IMPACT OF PLAYFUL INTERVENTIONS IN STUDENTS WITH STRESS AND ANXIETY THROUGH THE USE OF ELECTROENCEPHALOGRAPHIC SIGNALS AND ARTIFICIAL INTELLIGENCE
- ClinicalTrials.gov ID
- NCT07555158
- Acronym / sponsor ID
- ILOS-WEEG / 300/2/C/39/26
- Keywords
- Stress, Anxiety, university students, playful activities, academic performance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad Autonoma de Baja CaliforniaUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 29 Apr 2026 (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.
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.
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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Playful intervention. | Experimental | Behavioral: playful interventionParticipants engage in recreational activities designed to promote emotional regulation before the exam. |
| waiting list | No intervention | –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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| playful interventionAlso: Acceptance and Commitment Therapy, Guided drawing, Body micropracticeThe 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. | Behavioural | Playful intervention. |
Primary outcome
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.
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.
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.
4 secondary outcomes
Working memory
Time frame: Pre-Post intervention / 20-30 min.
Decision making
Time frame: Pre-Post intervention / 20-30 min
Inhibitory control
Time frame: Pre-Post intervention / 20-30 min.
Planning
Time frame: Pre-Post intervention / 20-30 min
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing playful intervention in people with Anxiety and Stress, run by Universidad Autonoma de Baja California.
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 6 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: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Stress (time frame: Pre-Post intervention / 1 Week). 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 29 Apr 2026.