Decoding Mechanisms of Pain Modulation

NCT05336370 | Completed

• 1 other identifier: 409472
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (1)

• Pain tolerance

  Time elapsed before removing the hand from the water.

  up to 10 minutes (During exposure (hand immersion in cold water))

Secondary Outcomes (2)

• Pain intensity

  Immediately after the cold pressor test

• Pain bothersomeness

  Immediately after the cold pressor test

Other Outcomes (2)

• Expectancies of coping

  Within 5 minutes pre- and within 5 minutes post intervention

• Expectancies of coping: pre-conscious

  Within 5 minutes pre- and within 5 minutes post intervention

Study Arms (3)

Hypnosis

EXPERIMENTAL

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

Behavioral: Hypnosis

Active tVNS

EXPERIMENTAL

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

Device: Vagus nerve stimulation

Sham tVNS

SHAM COMPARATOR

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

Device: Sham control

Interventions

Hypnosis BEHAVIORAL

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.

Hypnosis

Vagus nerve stimulation DEVICE

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.

Active tVNS

Sham control DEVICE

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

Sham tVNS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Oslo: lead

Study Sites (1)

University of Oslo

Oslo, Norway

Location

Related Links

• Related Info

MeSH Terms

Conditions

Acute Pain

Interventions

Hypnosis; Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The HypnoPain trial is designed as an experimental randomized controlled, statistician blinded superiority trial with three parallel groups

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 20, 2022
• Study Start: August 1, 2022
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: As soon as possible
• Access Criteria: Openly accessible

Locations

NO (1)