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Decoding Mechanisms of Pain Modulation (HypnoPain)

Primary Purpose

Pain, Acute

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Hypnosis
Vagus nerve stimulation
Sham control
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults aged 18-70 years
  • Fluent Norwegian language skills

Exclusion Criteria:

  • History of cardiovascular disease
  • Chronic pain conditions (any diagnoses resulting in chronic pain)

Sites / Locations

  • University of OsloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Hypnosis

Active tVNS

Sham tVNS

Arm Description

A brief hypnosis session will be provided to participants in this arm prior to immersion in the cold water.

Participants in the active tVNS condition will receive electronic stimulation of the vagus nerve prior to immersion in the cold water.

Participants in the sham tVNS will receive the electrode similar to the active treatment, but no stimulation will be performed.

Outcomes

Primary Outcome Measures

Pain tolerance
Time elapsed before removing the hand from the water.

Secondary Outcome Measures

Pain intensity
rated on a NRS 0-10 where 0 is "no pain" and 10 is "the worst pain imaginable"
Pain bothersomeness
NRS 0-10 where 0 is "not bothersome at all" and 10 is "the most bothersome imaginable"

Full Information

First Posted
April 12, 2022
Last Updated
November 23, 2022
Sponsor
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT05336370
Brief Title
Decoding Mechanisms of Pain Modulation
Acronym
HypnoPain
Official Title
Decoding Mechanisms of Pain Modulation Through Hypnosis and Vagus Nerve Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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 people's 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 (i.e. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The HypnoPain trial is designed as an experimental randomized controlled, statistician blinded superiority trial with three parallel groups
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The two vagus nerve stimulation arms are double-blinded, both for the participants and the outcome assessor, whilst the hypnosis arm is not possible to blind.
Allocation
Randomized
Enrollment
141 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypnosis
Arm Type
Experimental
Arm Description
A brief hypnosis session will be provided to participants in this arm prior to immersion in the cold water.
Arm Title
Active tVNS
Arm Type
Experimental
Arm Description
Participants in the active tVNS condition will receive electronic stimulation of the vagus nerve prior to immersion in the cold water.
Arm Title
Sham tVNS
Arm Type
Sham Comparator
Arm Description
Participants in the sham tVNS will receive the electrode similar to the active treatment, but no stimulation will be performed.
Intervention Type
Behavioral
Intervention Name(s)
Hypnosis
Intervention Description
The hypnosis will be conducted by clinical psychologists who have the formal competence and training in hypnosis. We will be using a tailored hypnosis script designed for this particular study, with a duration of 10-15 minutes. The script involves a hypnotic induction (relaxation-based), imagery (suggestions for pleasant visual imagery), a deepening procedure, and symptom-specific suggestions. The introduction begins by having the hypnotist debunk many of the common myths and misconceptions that patients may hold about hypnosis, and provide a description of hypnosis. Hypnosis is described as focused attention and concentration - like being so lost in a book or movie that it is easy to lose track of what is going on around you. Once the patient is deeply hypnotized, the therapist offers suggestions to reduce distress and improve pain tolerance.
Intervention Type
Device
Intervention Name(s)
Vagus nerve stimulation
Intervention Description
A CE approved tVNS device will be used to stimulate the afferent auricular branch of the vagus nerve located medial of the tragus at the entry of the acoustic meatus [36]. A standardized intensity of 10 mA with a pulse width of 250 μs and a consistent stimulation frequency of 25 Hz will be used for optimal stimulation. The stimulation will constantly alternate between active stimulation for 30 seconds, followed by a break of 30 seconds [37], and will have a duration of 15 minutes. Active tVNS is performed in a relaxed position, sitting back in a chair no more than 30 degrees from the horizontal, with both feet flat on the floor, and hands on thighs with palms facing downward. The bipolar stimulation electrode is placed correctly within the concha of the left ear. Participants are instructed to breathe normally while not talking or making any movements during their session.
Intervention Type
Device
Intervention Name(s)
Sham control
Intervention Description
Sham tVNS is performed in a relaxed position, sitting back in a chair no more than 30 degrees from the horizontal, with both feet flat on the floor, and hands on thighs with palms facing upward. The bipolar stimulation electrode is placed correctly within the concha of the left ear, but no actual stimulation will be performed. The electrode will be left on for 15 minutes. Participants are instructed to breathe normally while not talking or making any movements during their session
Primary Outcome Measure Information:
Title
Pain tolerance
Description
Time elapsed before removing the hand from the water.
Time Frame
up to 10 minutes (During exposure (hand immersion in cold water))
Secondary Outcome Measure Information:
Title
Pain intensity
Description
rated on a NRS 0-10 where 0 is "no pain" and 10 is "the worst pain imaginable"
Time Frame
Immediately after the cold pressor test
Title
Pain bothersomeness
Description
NRS 0-10 where 0 is "not bothersome at all" and 10 is "the most bothersome imaginable"
Time Frame
Immediately after the cold pressor test
Other Pre-specified Outcome Measures:
Title
Expectancies of coping
Description
NRS 0-10: "To what degree do you expect to cope with the painful procedure?"
Time Frame
Within 5 minutes pre- and within 5 minutes post intervention
Title
Expectancies of coping: pre-conscious
Description
The Function Acquisition Speed Test, linking verbal associations involving the painful procedure (CPT) and coping concordant and dis-concordant words
Time Frame
Within 5 minutes pre- and within 5 minutes post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults aged 18-70 years Fluent Norwegian language skills Exclusion Criteria: History of cardiovascular disease Chronic pain conditions (any diagnoses resulting in chronic pain)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silje Endresen Reme, PhD
Phone
22845236
Ext
47
Email
hypnovagus@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Henrik Børsting Jacobsen, PhD
Facility Information:
Facility Name
University of Oslo
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik B Jacobsen, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan to share the study protocol, README files as well the statistical codes for the main analysis in an open repository (e.g. Open Science Framework) to ensure transparency and reproducability.
IPD Sharing Time Frame
As soon as possible
IPD Sharing Access Criteria
Openly accessible
Links:
URL
https://www.uio.no/for-ansatte/arbeidsstotte/forskningsstotte/forskpro/prosjekter/sv/psi/Hypnose-og-vagusnervestimulering-for-smertetest/index.html
Description
Related Info

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Decoding Mechanisms of Pain Modulation

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