Hypnosis and Direct Autonomic Experience Influence on Chronic Symptoms

NCT ID: NCT04303143

Last Updated: 2020-07-29

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-31

Study Completion Date

2021-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Study will look at a limited number of participants with various chronic symptoms. Investigating a new and novel form of hypnosis application called "Direct Autonomic Experience (DAX)" which is using combination of visualization, metaphor, post-hypnotic suggestion and anchoring.

Purpose is to confirm that DAX generally appears to impact SUDS value and subjects report observed level of effect on short and longer term measurements.

Most significantly, testing that DAX technique/action is reusable later if the measured SUDS value returns or increases.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Hypnosis and Direct Autonomic Experience Influence on Chronic Symptoms One common characteristic of many chronic conditions is the neurology/ biology/ symptomology may change slightly or signficantly over time. So an initial process/plan that worked well for affecting a SUDS discomfort level, may no longer work or work as well.

DAX is designed to be adaptive such that as matters that affected the initial SUDS conditions may have changed, shifted, grown or otherwise be different.

(Examples are increased lesions with MS). Where initial patterns were created with a certain set of neural condition and pathways. But now days/weeks later, with new pathways created, can a previously installed DAX pattern adjust and shift to accommodate the new neural patterns based on participants willingness and self-instruction, or does it require professional adjustment.

Example participant given strong post-hypnotic suggestions/anchor/etc to squeeze right hand in certain way to bring relief to leg discomfort. Initial testing shows working. Now time has shifted, maybe new pathways or other chronic conditions have changed. Can the DAX processes the participant has been taught handle these changes or does it require a professional to re-apply/boost or incorporate new details to get significant changes to reported SUDS discomfort values.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Restless Legs Syndrome Multiple Sclerosis Trauma, Psychological Chronic Disease Trauma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Primary

Primary

Self-Hypnosis

Intervention Type BEHAVIORAL

Self-Hypnosis

Direct Autonomic Experience Control

Intervention Type BEHAVIORAL

Direct Autonomic Experience Control. Use of learned mental tool/process to affect outcome measure of SUDS discomfort experience. (eg. Squeeze hand as pre-learned mental anchor to relieve discomfort in lower legs)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Self-Hypnosis

Self-Hypnosis

Intervention Type BEHAVIORAL

Direct Autonomic Experience Control

Direct Autonomic Experience Control. Use of learned mental tool/process to affect outcome measure of SUDS discomfort experience. (eg. Squeeze hand as pre-learned mental anchor to relieve discomfort in lower legs)

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DAX Control

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participant must have a proper medical diagnosis of chronic condition.
* Existing medical treatments are having little to no effect on a discomfort metric to measure
* SUDS to be evaluated could be physical or emotional in nature (e.g. Anxiety level, or Leg Cramping/moving)
* Must be motivated and willing to participate in a study that uses hypnosis, placebo and/or nocebo type mental matters.
* Participant must continue existing medical treatments (as recommended/adjusted by such outside professionals) and continue to see and be monitored by new/existing medical professionals during the term of study.
* Must have technology of computers/internet/support to be able to attend regular video chat/conferences for needed interactions with study.
* Must have schedule availability and flexibility to meet in video chats/conferences as required.
* Must have the computer skills/resources and aptitude to handle video chat/conference and able to have resources/friends/knowledge that can help if technical issues arise to allow conference to occur (can handle restarting a video conference if crashes or network acts up)

Exclusion Criteria

* Acute and short term discomfort matters not being measured that outside scope of chronic condition.
* Must not be active in any other studies or such studies deemed to not interact with this.
* Does not have a properly diagnosed chronic condition (exception are control subjects)
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Inner Group Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martin Vendemia, BCH, MNLP

Role: PRINCIPAL_INVESTIGATOR

Inner Group Inc.

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Martin Vendemia, BCH, MNLP

Role: CONTACT

410-709-7449

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HypDax1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Post-stroke Pain taVNS
NCT06456385 COMPLETED NA