Mount Sinai Hospital
New York, 10029, United States
NCT Number: NCT07102810
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
New York, 10029, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: HGSHS:A
Time frame: During hypnosis session (single study visit)
Total score (0-12) reflecting responsiveness to hypnotic suggestion during standardized protocol. Higher scores suggest greater responsiveness to hypnotic suggestion.
Time frame: Immediately Pre- and immediately post-hypnosis session (single study visit)
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.
Time frame: Immediately Pre-, During, and immediately post-hypnosis session (single study visit)
Power values in EEG frequency bands collected across 21 electrodes during baseline, hypnotic induction, and post-session phases.
Time frame: Immediately Pre-, During, and immediately post-hypnosis session (single study visit)
Mean heart rate (beats per minute) captured continuously using a wearable chest patch before, during, and after hypnosis session.
Time frame: Immediately Pre-, During, and immediately post-hypnosis session (single study visit)
Time and frequency domain HRV metrics derived from wearable ECG data.
Time frame: Immediately Pre-, During, and immediately post-hypnosis session (single study visit)
Mean respiratory rate (breaths per minute) obtained from a respiration belt and ECG-derived signals.
Time frame: Immediately Pre-, During, and immediately post-hypnosis session (single study visit)
Skin conductance level and phasic response rate measured using BIOPAC sensors.
Time frame: Immediately Pre-, During, and immediately post-hypnosis session (single study visit)
Pre-ejection period (ms), a marker of sympathetic nervous system activity, measured via seismocardiogram from chest patch.
Time frame: Immediately Pre-, During, and immediately post-hypnosis session (single study visit)
RSA index (ms²), derived from heart rate and respiration synchrony during hypnotic protocol.
Icahn School of Medicine at Mount Sinai
Other
Standardized Hypnotic Susceptibility Testing to Facilitate Development of a Machine Learning Tool to Characterize Physiological Biomarkers of Calm and Tranced States
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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