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Clinical Trials in Poland / NCT07437833
Recruiting Not applicable

Psychophysiological Responses to Six Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder

NCT07437833 · tracked via the Priya Life Science Poland tracker
Phase
Not applicable
Started
2026-07-31
Last updated
2026-08-03

Condition(s) studied

ADHD - Attention Deficit Disorder With HyperactivityBipolar Affective Disorder; Remission in

Investigational drug(s) / intervention(s)

Moderate-Intensity Aerobic Exercise on CycloergometerCyclic SighingAromatherapyMusic TherapyVirtual Reality Nature ImmersionEmotional Freedom Technique TappingResting State (Control Session)

Moderate-Intensity Aerobic Exercise on Cycloergometer: The participant performs a 15-minute session of moderate-intensity cycling on a stationary ergometer. Moderate intensity is defined as 64-76% of maximum heart rate according to ACSM guidelines. The exercise load is set to 2 watts per kilogram of body weight. Heart rate is monitored using a Polar chest strap.

Cyclic Sighing: The participant performs cyclic sighing for 15 minutes while sitting in a chair. They inhale slowly, and once the lungs are expanded, perform a second inhale to maximally fill the lungs, even if the second inhale is shorter or smaller in volume than the first. They then slowly and fully exhale all their breath. The participant performs all inhales and exhales through the nose.

Aromatherapy: The participant undergoes a 15-minute aromatherapy session while sitting comfortably in a chair in a closed room (2 m × 4 m). Lavender essential oil is diffused into the air using an aroma diffuser placed approximately 1 meter from the participant. The participant breathes normally and does not perform controlled breathing.

Music Therapy: The participant listens to 528 Hz solfeggio frequency music for 15 minutes while seated comfortably in a quiet, closed room. Music is delivered through headphones or a speaker at a comfortable volume.

Virtual Reality Nature Immersion: The participant wears a VR headset and views a 15-minute immersive forest and nature environment while seated comfortably in a quiet, closed room. The VR experience includes visual and auditory elements of a natural forest scene.

Emotional Freedom Technique Tapping: The participant performs a 15-minute Emotional Freedom Technique (EFT) tapping session while seated comfortably in a quiet, closed room. The participant taps on standardized acupressure points in the following order: karate chop (side of hand), inner eyebrow, side of eye, under eye, under nose, chin, collarbone, under arm, and top of head. Each point is tapped 10-15 times with steady, moderate pressure.

Resting State (Control Session): The participant sits quietly in a chair with eyes open for 15 minutes in a calm, closed room. No active intervention, tapping, breathing exercises, music, aromatherapy, or virtual reality is administered during this session. The participant is instructed to remain seated with eyes open maintaining a natural posture without engaging in any structured activity.

Study summary

This study aims to explore how six short, 15-minute self-regulation techniques affect the body and brain in a female adult with ADHD and stabilized bipolar disorder. The techniques being tested include:

* Aerobic exercise
* Controlled breathing (cyclic sighing)
* Aromatherapy with lavender essential oil
* Listening to specific music (Solfeggio 528 Hz)
* Virtual reality relaxation with forest imagery
* Emotional Freedom Technique (EFT) tapping One session of quiet sitting with eyes open serves as a comparison.

The participant will attend one 15-minute session per week for each technique. Before and after each session, the researchers will measure:

* Heart rate and heart rate variability
* Stress levels using Subjective Units of Distress Scale
* Mood using a questionnaire
* Blood pressure
* Brain activity using EEG
* Memory performance with a simple test (N-back)
* Pain sensitivity The goal is to understand how these short, non-invasive techniques influence both physiological and psychological responses. Sessions are safe, short, and designed to involve minimal risk. The findings may help guide future research on relaxation and exercise strategies for people with ADHD and bipolar disorder.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
35 Years
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of ADHD and bipolar disorder (type I or II) in stable remission. * No active depressive, manic, or psychotic episodes for at least 2 years. * No use of psychotropic medications, including mood stabilizers, antidepressants, antipsychotics, or ADHD medications, for at least 2 years. * No chronic somatic diseases (including neurological, cardiovascular, or metabolic disorders). * Regular sleep-wake rhythm during the week preceding the study. * Non-smoker. * No night-shift work in the week preceding the study. Exclusion Criteria: * Acute medical conditions that could affect study procedures. * Use of medications in the past 3 months that influence cardiovascular or neurological parameters. * Consumption of alcohol or psychoactive substances on the day before or day of the study. * Intense physical activity on the day before or day of the study. * Contraindications to moderate-intensity exercise on a cycle ergometer (e.g., recent injuries, chronic musculoskeletal conditions). * Contraindications to EEG measurement (e.g., scalp skin conditions preventing proper electrode placement, hypersensitivity to conductive gels or pastes).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Poznan University of Physical Education Poznan Poland Recruiting

More Poznan University of Physical Education trials in Poland

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07437833 on ClinicalTrials.gov ↗ ← All trials in Poland