Hypnosis in Autonomic Function

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00061009
First received: May 19, 2003
Last updated: March 3, 2008
Last verified: January 2006
  Purpose

This study will investigate the relationship between susceptibility to hypnosis and regulation of the autonomic nervous system (nerves that control involuntary body functions, such as heart rate and sweating).

Hypnosis is a state of mind in which the individual is highly focused, relatively unaware of his or her surroundings, and possibly more able to accept and use therapeutic suggestions. People vary in their responsiveness, or susceptibility, while in hypnosis. People with certain conditions, such as chronic fatigue syndrome (CFS), chronic pain, posttraumatic stress disorder (PTSD), and generalized anxiety disorder (GAD) have altered hypnotic susceptibility. Patients with chronic orthostatic intolerance (COI) often have symptoms similar to those of individuals with CFS, chronic pain, PTSD, and GAD, and this study will examine how patients with COI respond to hypnosis as compared with healthy normal volunteers. COI is a group of disorders characterized by intolerance to prolonged standing. Among them are neurocardiogenic syncope (NCS), in which patients have recurrent episodes of sudden loss of consciousness, and postural tachycardia syndrome (POTS), in which patients have a sustained increase in heart rate after standing.

In addition to the comparison of COI and normal volunteer responses to hypnosis, the study will examine how hypnotic susceptibility is related to the ability to control autonomic functions such as blood pressure, heart rate, and sweating. The autonomic nervous system is activated when the body is stressed, not only from physical stimuli such as cold temperature, but also from mental stimuli, such as seeing a rattlesnake up close. Hypnosis may, therefore, be a useful tool to understand how the mind controls the autonomic nervous system.

Healthy normal volunteers and patients with NCS or POTS who are 18 years of age or older may be eligible for this two-part study. In part 1, participants complete a questionnaire and are then tested for hypnotic susceptibility. For this test, a professionally trained physician guides the subject through a procedure to achieve a hypnotic state. The subject is asked to perform several simple tasks and is then guided back to a normal state of being. In part 2, the subject undergoes hypnosis again, during which the physician offers various suggestions while monitoring activity of the subject's autonomic nervous system. The subject is connected to various sensors that continuously monitor blood pressure, heart rate, blood flow, sweat response, skin electrical conduction, and brain wave activity. An intravenous catheter is inserted into an arm vein to collect blood samples. At the end, the subject is guided back to a normal state of being.

The hypnosis session in part 1 is videotaped in order to: 1) permit review by a scientist who is unaware of the subject's condition and whose judgment will not, therefore, be biased; and 2) have a record of the experimental data. Only qualified investigators will view the videotape.


Condition
Vasovagal Syncope
Postural Tachycardia Syndrome
Hypnosis

Study Type: Observational
Official Title: Relationship of Autonomic Function to Hypnotic Susceptibility

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 93
Study Start Date: May 2003
Estimated Study Completion Date: January 2006
Detailed Description:

This protocol describes a study to investigate the relationship between susceptibility to hypnosis and regulation of the autonomic nervous system. Several studies have demonstrated that individuals with particular conditions such as chronic fatigue syndrome (CFS), posttraumatic stress disorder (PTSD), chronic pain, and generalized anxiety disorder (GAD), have altered hypnotic susceptibility. Patients with chronic orthostatic intolerance (COI), a general category of autonomic dysfunction that includes neurocardiogenic syncope (NCS) and postural tachycardia syndrome (POTS), often present with symptoms that are similar to those seen in CFS, PTSD, chronic pain, or GAD. These observations led to the hypothesis tested in this protocol that patients with COI may also have altered hypnotic susceptibility. We also hypothesize that increased hypnotic susceptibility will correlate with increased ability to modulate autonomic function appropriately in response to suggestions during hypnosis.

The study population includes normal volunteers and patients with NCS or POTS. The design is blinded and correlative. Primary outcome measures are hypnotic susceptibility as measured by standardized scales; self-report inventory scores of psychobehavioral variables; physiologic parameters such as hemodynamics, sweating, skin electrical conductance, body temperature, respiratory rate, and bispectral analysis; and plasma catechol levels. The results of this study may lead to novel therapeutic strategies using hypnosis for COI.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA:

Subjects are patients with COI (POTS or NCS) identified in existing diagnostic protocols of the Clinical Neurocardiology Section (CNCS) and age- and gender-matched healthy volunteers. Patients with COI must be evaluated first through these diagnostic protocols prior to being offered enrollment in this protocol. Participation in this protocol is offered to subjects independently of gender, race, ethnicity, religion, or creed.

The studies in this protocol can be performed on an outpatient basis. Inpatients may also participate as long as participation does not interfere with the protocol(s) under which they have been admitted.

EXCLUSION CRITERIA:

Subjects are excluded based on: age less than 18 years, unwillingness to be hypnotized or videotaped; religious or other beliefs that would prevent engagement in hypnosis; psychosis or psychotic depression; non-fluency in spoken English; and inability to participate adequately in the tasks of the hypnotic susceptibility scale. In addition, patients are excluded if they are being treated with, and cannot discontinue, a drug likely to interfere with the scientific results. An example would be treatment with a beta-adrenoceptor blocker. Patients unable to discontinue nicotine or alcohol temporarily are excluded. Patients are not to discontinue any medications before the patient or the patient's doctor discusses this with the Principal Investigator, or the Research Nurse. If it is decided that discontinuing medications would be unsafe, then the patient is excluded from the study. Finally, subjects are excluded if there are technical limitations in placing an i.v. or monitoring devices.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061009

Locations
United States, Maryland
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00061009     History of Changes
Other Study ID Numbers: 030199, 03-N-0199
Study First Received: May 19, 2003
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Chronic Orthostatic Intolerance
Dysautonomia
Postural Tachycardia Syndrome
Neurocardiogenic
Syncope
Neurocardiogenic Syncope
COI
Postural Tachycardia Syndrome
POTS
Neurocardogenic Syncope
NCS
Healthy Volunteer
HV

Additional relevant MeSH terms:
Postural Orthostatic Tachycardia Syndrome
Syncope
Syncope, Vasovagal
Syndrome
Tachycardia
Arrhythmias, Cardiac
Autonomic Nervous System Diseases
Cardiovascular Diseases
Consciousness Disorders
Disease
Heart Diseases
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Orthostatic Intolerance
Pathologic Processes
Primary Dysautonomias
Signs and Symptoms
Unconsciousness

ClinicalTrials.gov processed this record on October 23, 2014