Disorder; TranceNCT07102810
Hypnosis-Based Machine Learning Biomarker Study
A study testing Standardized Hypnotic Susceptibility Testing in people with Disorder; Trance and Anxiety, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorder; Trance, Anxiety
- What is being tested?
- Standardized Hypnotic Susceptibility Testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2025to 9 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standardized Hypnotic Susceptibility Testing to Facilitate Development of a Machine Learning Tool to Characterize Physiological Biomarkers of Calm and Tranced States
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.
Read the detailed description
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
- Disorder; Trance, Anxiety
- Being tested
- Standardized Hypnotic Susceptibility Testing
- Keywords
- Hypnosis, Trance, Anxiety, Machine Learning, Calm
- Medical subject headings
- Osteopetrosis, mild autosomal recessive form, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Hypnotic Susceptibility TestingBehavioural
Also called HGSHS:A
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Standardized Hypnotic Susceptibility Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During hypnosis session (single study visit)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately Pre-, During, and immediately post-hypnosis session (single study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start4 Aug 2025
- Primary completion9 Sep 2025
- Study completion9 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder; TranceStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Entrancing Entertainment, Inc.
- Responsible party
- Principal investigator, David Reich, Icahn School of Medicine at Mount Sinai
- Investigators
- David L Reich, MD, Principal investigator, Icahn School of Medicine at Mount Sinai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102810
- Sponsor's protocol ID
- STUDY-25-00767
- Status last verified
- Sep 2025
- First submitted
- 30 Jul 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate deidentified data and results will be shared. Individual participant video and EEG data will not be shared due to PHI concerns.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Hypnotic Susceptibility Testing to Facilitate Development of a Machine Learning Tool to Characterize Physiological Biomarkers of Calm and Tranced States
- ClinicalTrials.gov ID
- NCT07102810
- Acronym / sponsor ID
- STUDY-25-00767
- Conditions
- Disorder; Trance, Anxiety
- Keywords
- Hypnosis, Trance, Anxiety, Machine Learning, Calm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Entrancing Entertainment, Inc.
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 9 Sep 2025 (actual)
- Study completion
- 9 Sep 2025 (actual)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Guided Hypnosis | Experimental | Behavioral: Standardized Hypnotic Susceptibility TestingAll participants will undergo a single, standardized hypnotic susceptibility protocol using the Harvard Group Scale of Hypnotic Susceptibility: Form A (HGSHS:A). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Hypnotic Susceptibility TestingAlso: HGSHS:AParticipants 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. | Behavioural | Guided Hypnosis |
Primary outcome
Harvard Group Scale of Hypnotic Susceptibility (HGSHS:A) Total Score
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.
8 secondary outcomes
State-Trait Anxiety Inventory (STAI) Subscale Scores
Time frame: Immediately Pre- and immediately post-hypnosis session (single study visit)
EEG Spectral Power
Time frame: Immediately Pre-, During, and immediately post-hypnosis session (single study visit)
Heart Rate (HR)
Time frame: Immediately Pre-, During, and immediately post-hypnosis session (single study visit)
Heart Rate Variability (HRV)
Time frame: Immediately Pre-, During, and immediately post-hypnosis session (single study visit)
Respiratory Rate (RR)
Time frame: Immediately Pre-, During, and immediately post-hypnosis session (single study visit)
Electrodermal Activity (EDA)
Time frame: Immediately Pre-, During, and immediately post-hypnosis session (single study visit)
Pre-Ejection Period (PEP)
Time frame: Immediately Pre-, During, and immediately post-hypnosis session (single study visit)
Respiratory Sinus Arrhythmia (RSA)
Time frame: Immediately Pre-, During, and immediately post-hypnosis session (single study visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No. Aggregate deidentified data and results will be shared. Individual participant video and EEG data will not be shared due to PHI concerns.
Related trials for Disorder; Trance
Active, not recruiting
Cognitive Trance, Hypnosis and Meditation in Oncology
Cancer, Distress, Emotional
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David L Reich, MD principal investigator
Icahn School of Medicine at Mount Sinai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Hypnotic Susceptibility Testing in people with Disorder; Trance and Anxiety, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harvard Group Scale of Hypnotic Susceptibility (HGSHS:A) Total Score (time frame: During hypnosis session (single study visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.