ClinicalTrials.gg
Not yet recruitingNCT07555158ILOS-WEEGUpdated Apr 29, 2026

Impact of Play Interventions on Stress and Anxiety Using EEG and AI.

An interventional study of playful intervention in Anxiety and Stress, sponsored by Universidad Autonoma de Baja California. Not yet recruiting. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Universidad Autonoma de Baja California · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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. 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:

  1. 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."
  2. 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.

02

Conditions studied

  • Anxiety
  • Stress

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Keywords

  • Stress
  • Anxiety
  • university students
  • playful activities
  • academic performance
03

In context

Anxiety Disorders Unverified

7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Universidad Autonoma de Baja California is the lead sponsor of 33 studies on the registry; 12 are open to participants now.

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 form.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Playful intervention.

    Participants engage in recreational activities designed to promote emotional regulation before the exam.

    Behavioral: playful intervention

  • 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.

Interventions

  • Behavioralplayful intervention

    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.

    Also known as: Acceptance and Commitment Therapy, Guided drawing, Body micropractice

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Pre-Post intervention / 1 Week

  2. 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.

    Time frame: Pre-Post intervention / 1 Week

  3. 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.

    Time frame: During the intervention (20 min)

Secondary outcomes

  1. 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.

    Time frame: Pre-Post intervention / 20-30 min.

  2. 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.

    Time frame: Pre-Post intervention / 20-30 min

  3. 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.

    Time frame: Pre-Post intervention / 20-30 min.

  4. 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.

    Time frame: Pre-Post intervention / 20-30 min

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Oct 2026, 2 months later.

Of 3,836 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 2 months is below that.

Counting every sponsor, half of 3,938 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 21, 2026
First posted
Apr 29, 2026
StartEst.
Aug 30, 2026
Primary completionEst.
Oct 30, 2026
CompletionEst.
Mar 15, 2027
Last update
Apr 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07555158
Lead sponsor
Universidad Autonoma de Baja California
Responsible party
Gilberto Galindo (full time researcher, Universidad Autonoma de Baja California) — Principal investigator
First posted
Apr 29, 2026
Start date
Aug 30, 2026 (estimated)
Primary completion
Oct 30, 2026 (estimated)
Completion
Mar 15, 2027 (estimated)
Last update
Apr 29, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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