Набор скоро начнётся NCT07620639

Consciousness Studies and Cardiovascular Health

Без фазы С лечением Blood Pressure Relaxation Virtual Reality

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Virtual Reality Relaxation, Video Meditation, Live Guided.
Кому может быть актуально: Состояния в реестре: Blood Pressure, Relaxation, Virtual Reality. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The objective of the study is to evaluate whether a virtual reality (VR) based intervention combining binaural beats, photic stimulation, and real-time biofeedback reduces stress and improves physiological markers compared to non-VR interventions and usual care in patients that go to cardiology clinic.

Вмешательства

Поведенческое Virtual Reality Relaxation
Participants will wear a virtual reality headset delivering a guided relaxation experience. The VR program includes: immersive visual environments designed to induce calmness, binaural audio beats engineered to promote relaxation, and photic (light) stimulation synchronized with audio and breath cues. The intervention is designed to support autonomic down-regulation and enhance the participant's relaxation response.
Поведенческое Video Meditation
Participants will view a guided meditation video displayed on a screen. The video includes: soothing visual imagery, gentle narration guiding breath and awareness, calming background music. This intervention is intended to facilitate psychological relaxation through traditional audiovisual meditation techniques.
Поведенческое Live Guided
Participants will receive a live, instructor-led relaxation session conducted by a trained study team member. The facilitator will guide the participant through: controlled breathing exercises, progressive muscle relaxation, calming verbal prompts, and mindfulness-based awareness techniques. The goal is to induce relaxation through direct interpersonal guidance.

Первичные конечные точки

Change in Self-Reported Stress [Срок оценки: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)]

Вторичные конечные точки (3)

Change in Heart Rate Variability (HRV) [Срок оценки: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)]
Change in Galvanic Skin Response (GSR) [Срок оценки: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)]
Change in Electroencephalogram (EEG)-Derived Neural Activity [Срок оценки: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)]

Критерии участия

Критерии включения

Age 18 and older
Able to provide informed consent (English only for pilot)
Chronic Selective Serotonin Reuptake Inhibitors/ Serotonin-norepinephrine reuptake inhibitors (SSRI/SNRI) or Attention Deficit/ Hyperactivity Disorder (ADHD) meds allowed (recorded)
Normal vision and hearing
Stable vitals (HR 55-100 bpm, Systolic Blood Pressure (SBP) 90-160mmHg (millimeters of mercury, afebrile)
Willing to abstain 6 hours pre-session from caffeine, nicotine, heavy exercise
Willing to tolerate electroencephalogram (EEG) headband, Galvanic Skin Response (GSR) electrodes are small sensors placed on the skin (usually fingers or palm) and virtual reality (VR) headset