Ignite Creation Date:
2024-05-06 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05336370
Status:
COMPLETED
Last Update Posted:
2023-12-04
First Post:
2022-04-12
Brief Title:
Decoding Mechanisms of Pain Modulation
Sponsor:
University of Oslo
Organization:
University of Oslo
Study Overview
Official Title:
Decoding Mechanisms of Pain Modulation Through Hypnosis and Vagus Nerve Stimulation
Status:
COMPLETED
Status Verified Date:
2023-12
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:
HypnoPain
Brief Summary:
The main objective of this experimental trial is to gain further insights into the mechanisms of pain modulation and more specifically whether expectations of coping is one of the involved mechanisms This will be investigated by comparing two different interventions known to influence pain perception hypnosis and non-invasive stimulation of the vagus nerve prior to a pain exposure task hand immersion in cold water Expectations will be assessed both pre- and post intervention
Detailed Description:
Pain is a subjective experience influenced by biological psychological and social factors This multidimensional view of pain has led to various efforts to affect peoples pain experience Nonpharmacological interventions such as hypnosis have proven successful in reducing pain whilst providing few if any negative side effects Hypnosis involves a state of highly focused attention with a constriction in peripheral awareness and a heightened responsiveness to social cues This particular state can exert a powerful influence on the mind and body yet the mechanisms responsible for this effect remains to a large degree unknown The aim of this study is to investigate the effect of hypnosis given prior to a painful procedure cold pressor test CPT to investigate the effect on pain perception and tolerance but most importantly to investigate if the effect is mediated by a change in expectations of coping Previous studies have provided support for the the effect of hypnosis on expectations but they have focused exclusively on stimulus expectancies expectations of pain intensity while the current study will focus on response outcome expectancies expectations of coping in line with the Cognitive Activation Theory of Stress CATS
Whilst hypnosis may dampen the stress response through expectancies top-down another way of dampening the stress response is through transcutaneous vagus nerve stimulation tVNS bottom-up Vagus nerve stimulation is proposed as another nonopioid pain treatment with minimal side effects The vagus nerve is the 10th cranial nerve connecting the viscera and the brain and influencing multiple systems of the body including the cardiac immunologic and endocrine system and the activity of many visceral organs This makes the vagus nerve a possibly important mediating transmitting and modulating nerve of pain signals Stimulation of the vagus nerve is believed to modulate pain by inhibiting inflammation oxidative stress and sympathetic activity and possibly also by inducing a brain activation pattern that may be incongruent with the pain matrix ie brain regions commonly active during pain VNS might also mediate the effects of the opioid system in pain modulation These mechanisms have in common that they are hypothesized to affect neuronal hyperexcitability resulting in a reduced pain perception which is supported by experimental animal studies
Whilst hypnosis may dampen the stress response through expectancies top-down another way of dampening the stress response is through transcutaneous vagus nerve stimulation tVNS bottom-up Vagus nerve stimulation is proposed as another nonopioid pain treatment with minimal side effects The vagus nerve is the 10th cranial nerve connecting the viscera and the brain and influencing multiple systems of the body including the cardiac immunologic and endocrine system and the activity of many visceral organs This makes the vagus nerve a possibly important mediating transmitting and modulating nerve of pain signals Stimulation of the vagus nerve is believed to modulate pain by inhibiting inflammation oxidative stress and sympathetic activity and possibly also by inducing a brain activation pattern that may be incongruent with the pain matrix ie brain regions commonly active during pain VNS might also mediate the effects of the opioid system in pain modulation These mechanisms have in common that they are hypothesized to affect neuronal hyperexcitability resulting in a reduced pain perception which is supported by experimental animal studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None