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

NCT07555158 | Not Yet Recruiting DMC

• 1 other identifier: 300/2/C/39/26
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Anxiety; Stress

Keywords

Stress; Anxiety; university students; playful activities; academic performance

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  During the intervention (20 min)

Secondary Outcomes (4)

• Working memory

  Pre-Post intervention / 20-30 min.

• Decision making

  Pre-Post intervention / 20-30 min

• Inhibitory control

  Pre-Post intervention / 20-30 min.

• Planning

  Pre-Post intervention / 20-30 min

Study Arms (2)

Playful intervention.

EXPERIMENTAL

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

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.

Interventions

playful intervention BEHAVIORAL

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

Playful intervention.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: full time researcher

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): March 15, 2027
• Last Updated: April 29, 2026

Record last verified: 2025-06