Hypnosis-Based Machine Learning Biomarker Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-04

Study Completion Date

2025-09-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Disorder; Trance Anxiety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Guided Hypnosis

All participants will undergo a single, standardized hypnotic susceptibility protocol using the Harvard Group Scale of Hypnotic Susceptibility: Form A (HGSHS:A).

Group Type EXPERIMENTAL

Standardized Hypnotic Susceptibility Testing

Intervention Type 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.

Interventions

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Standardized Hypnotic Susceptibility Testing

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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HGSHS:A

Eligibility Criteria

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Inclusion Criteria

* Written informed consent obtained from participant and ability and willingness for participant to comply with the requirements of the study.
* Adults of all genders, ages 18-65
* Healthy volunteers
* English-speaking

Exclusion Criteria

* Participating currently in experimental drug trials.
* Recent (\<1 year) or current history of substance use disorder.
* Diabetes T1 or T2, major cardiovascular or respiratory diseases, major neurological diseases, or limited mobility
* Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
* Adults that cannot consent.
* Chronic use of psychoactive medications.
* Chronic use of antiepileptic medications.
* Active substance use disorder.
* Participants reporting significant phobias or anxiety disorders triggered by imagery or situations involving insects (specifically flies), enclosed spaces or elevators (claustrophobia), or heights (acrophobia).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes