Hypnosis and Direct Autonomic Experience Influence on Chronic Symptoms

NCT04303143 | Unknown

• 1 other identifier: HypDax1
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Restless Legs Syndrome; Multiple Sclerosis; Trauma, Psychological; Chronic Disease; Trauma

Keywords

hypnosis; trauma; chronic disease

Outcome Measures

Primary Outcomes (1)

• SUDS

  Subject Unit of Discomfort Symptom. Each patient will have different types and levels of discomfort. Could be back, legs, whatever. Once identified and a numerical value applied to level of discomfort on scale of 1 to 10. We will track that particular SUDS metric through the study, looking for various factors that enable the measured value to drop to lowest value and to re-correct back to lower value if conditions cause it to rise again.

  7 days

Secondary Outcomes (2)

• DAX Control of SUDS Change

  1 day

• Professional Control of SUDS change

  1 day

Study Arms (1)

Primary

Primary

Behavioral: Self-Hypnosis; Behavioral: Direct Autonomic Experience Control

Interventions

Self-Hypnosis BEHAVIORAL

Self-Hypnosis

Primary

Direct Autonomic Experience Control 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)

Also known as: DAX Control

Primary

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Open to anyone over age or 12 (with proper adult/guardian supervision/authorization) with a proper medical chronic condition with one discomfort item (may have many, but only picking one) to be measured and evaluated over term of this study

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Inner Group Inc.: lead

MeSH Terms

Conditions

Restless Legs Syndrome; Multiple Sclerosis; Psychological Trauma; Chronic Disease; Wounds and Injuries

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Martin Vendemia, BCH, MNLP

  Inner Group Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Vendemia, BCH, MNLP

CONTACT

410-709-7449; Martin@innergroupinc.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2020
• First Posted: March 10, 2020
• Study Start: March 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share