Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061009
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2003-05-19
Brief Title:
Hypnosis in Autonomic Function
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Relationship of Autonomic Function to Hypnotic Susceptibility
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 subjects 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 subjects 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
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 subjects 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 subjects 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-N-0199 | None | None | None |