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| Name | Class |
|---|---|
| Entrancing Entertainment, Inc. | UNKNOWN |
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This study seeks to contribute to the growing body of literature on hypnosis by providing robust, data-driven insights into the physiological mechanisms underlying trance states. The integration of electroencephalogram (EEG) and other wearable-derived physiological data will offer a comprehensive assessment of the changes that occur during a standardized hypnosis protocol: the Harvard Group Scale of Hypnotic Susceptibility (HGSHS:A). The results of this study are intended to facilitate derivation and validation of an Artificial Intelligence/Machine Learning (AI/ML)-based monitor that quantifies a patient's instantaneous emotional/arousal state along the spectrum that spans anxiety through states of calmness and trance. Future investigations will explore the ability of using such an interactive virtual system as a component of a closed-loop adaptive device to create optimal states of non-pharmacological sedation using personalized audiovisual content to allay anxiety and discomfort during medical procedures, such as percutaneous biopsies.
This is an interventional study that will acquire data to characterize the time course of physiological biomarkers and audiovisual observations of depth of trance before, during and upon emergence from a standardized hypnotic susceptibility protocol. The subjects will also complete the State Trait Anxiety Inventory (STAI) immediately before and after the hypnosis protocol. The differences in the biomarker signals among subjects of different degrees of hypnotic susceptibility and different pre-post levels of state anxiety will facilitate between- and within-subjects comparisons that will be supplemented by computer vision analysis of subject responses. The full data set will be used to facilitate derivation and validation of a novel machine-learning monitoring tool to measure instantaneous emotional/arousal levels along a spectrum that spans anxiety through calmness and trance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guided Hypnosis | Experimental | All participants will undergo a single, standardized hypnotic susceptibility protocol using the Harvard Group Scale of Hypnotic Susceptibility: Form A (HGSHS:A). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized Hypnotic Susceptibility Testing | Behavioral | Participants will be guided through the Harvard Group Scale of Hypnotic Susceptibility: Form A (HGSHS:A), a validated group hypnosis protocol that includes standardized hypnotic inductions and suggestibility tasks. |
| Measure | Description | Time Frame |
|---|---|---|
| Harvard Group Scale of Hypnotic Susceptibility (HGSHS:A) Total Score | Total score (0-12) reflecting responsiveness to hypnotic suggestion during standardized protocol. Higher scores suggest greater responsiveness to hypnotic suggestion. | During hypnosis session (single study visit) |
| Measure | Description | Time Frame |
|---|---|---|
| State-Trait Anxiety Inventory (STAI) Subscale Scores | The State-Trait Anxiety Inventory is a 40-item instrument divided into two subscales: state and trait anxiety. State Subscale range from 20-80, with higher score suggesting more anxiety at a particular moment in time. Trait Subscale range from 20-80, with higher score suggesting general anxiety feelings overall. These will not be summed therefore there will not be one total scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David L Reich, MD | Icahn School of Medicine at Mount Sinai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | New York | New York | 10029 | United States |
Aggregate deidentified data and results will be shared. Individual participant video and EEG data will not be shared due to PHI concerns.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 15, 2025 | Sep 9, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| C536059 | Osteopetrosis, mild autosomal recessive form |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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This project will facilitate within-subjects and between-subjects comparisons in a limited number of subjects exposed to a standardized hypnotic susceptibility protocol -- the Harvard Group Scale of Hypnotic Susceptibility (HGSHS:A). This is a widely used test to assess an individual's susceptibility to hypnotic suggestion. The State Trait Anxiety Inventory (STAI) will be perform immediately prior to and following the hypnotic protocol. Together, these reliable and valid data will serve as the gold standards to facilitate training of a machine-learning model that will attempt to use physiological data (EEG and wearable-derived) and high-resolution audiovisual recordings of subject/hypnotist responses to develop a patient monitoring tool that measures emotional/arousal states spanning the spectrum from anxiety through calm.
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| Immediately Pre- and immediately post-hypnosis session (single study visit) |
| EEG Spectral Power | Power values in EEG frequency bands collected across 21 electrodes during baseline, hypnotic induction, and post-session phases. | Immediately Pre-, During, and immediately post-hypnosis session (single study visit) |
| Heart Rate (HR) | Mean heart rate (beats per minute) captured continuously using a wearable chest patch before, during, and after hypnosis session. | Immediately Pre-, During, and immediately post-hypnosis session (single study visit) |
| Heart Rate Variability (HRV) | Time and frequency domain HRV metrics derived from wearable ECG data. | Immediately Pre-, During, and immediately post-hypnosis session (single study visit) |
| Respiratory Rate (RR) | Mean respiratory rate (breaths per minute) obtained from a respiration belt and ECG-derived signals. | Immediately Pre-, During, and immediately post-hypnosis session (single study visit) |
| Electrodermal Activity (EDA) | Skin conductance level and phasic response rate measured using BIOPAC sensors. | Immediately Pre-, During, and immediately post-hypnosis session (single study visit) |
| Pre-Ejection Period (PEP) | Pre-ejection period (ms), a marker of sympathetic nervous system activity, measured via seismocardiogram from chest patch. | Immediately Pre-, During, and immediately post-hypnosis session (single study visit) |
| Respiratory Sinus Arrhythmia (RSA) | RSA index (ms²), derived from heart rate and respiration synchrony during hypnotic protocol. | Immediately Pre-, During, and immediately post-hypnosis session (single study visit) |