The Effect of Hypnosis on Blood Concentrations of Endocannabinoids

NCT03407937 | Completed

• 1 other identifier: 2017-1477
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Many interventions such as hypnosis, mindfulness meditation, conditioned pain modulation and placebos have been shown to effectively reduce pain both in the laboratory and in clinical settings. However, little is known about their neurophysiological mechanisms of action. Analgesia induced by these techniques is thought to be based on opioidergic and non-opioidergic mechanisms (potentially endocannabinoid mechanisms). Objective: Our main objective is to evaluate the effect of hypnosis, meditation, conditioned pain modulation and placebo on blood concentrations of endocannabinoids (anandamide, 2-arachidonylglycerol, N-palmitoyl-ethanolamine, N-oleoylethanolamide), endogenous opioids (β-endorphins, met / leu-enkephalins, and dynorphins) and norepinephrine in healthy adults. Methods: This study is based on a single-group pre-experimental research design in which two experimental sessions including hypnosis or meditation, conditioned pain modulation and placebo interventions will be completed by all participants. In order to have a better description of the sociodemographic and clinical characteristics of the sample, information will be collected by questionnaires or tests filled by participants at baseline, including: age, sex, language, culture, religion, salary, menstrual cycle of women, medication (if any), mood, anxiety, pain catastrophizing, mindfulness, hypnotic susceptibility, and DNA information. Outcome measures will be collected before, during and after each intervention. The primary outcome is plasma concentrations of endocannabinoids. Secondary measurements include plasma concentrations of endogenous opioids and norepinephrine; change in pain intensity during the thermal noxious stimuli; and autonomic nervous system variability (as measured by heart rate variability). Anticipated results: The investigators expect a positive relationship between the change in pain intensity (analgesia) induced by the interventions (hypnosis, meditation, conditioned pain modulation, and placebo) and the change (increase) in plasma concentrations of endocannabinoids, opioids, and norepinephrine in healthy adults. It is also believed that the interventions will influence heart rate variability. Moreover, it is expected that there will be a relationship between the efficiency of the analgesic intervention and some gene polymorphisms associated to pain modulation and endocannabinoids, opioids or norepinephrine in healthy individuals.

Conditions

Hypnosis; Endocannabinoids; Analgesia

Keywords

Hypnosis; Meditation; Conditioned pain modulation; Placebo; Endocannabinoids; Opioid peptides; Norepinephrine; Pain; Analgesia; Genes; Heart rate variability

Outcome Measures

Primary Outcomes (1)

• Change from baseline concentration of endocannabinoids at the end of the intervention

  Concentrations (ng/ml) of endocannabinoids (anandamide, 2-arachidonylglycerol, N-palmitoyl-ethanolamine, N-oleoylethanolamide) will be measured in the plasma of participants

  Immediately before and after each intervention

Secondary Outcomes (5)

• Change from baseline concentrations of opioids at the end of the intervention

  Immediately before and after each intervention

• Change from baseline concentrations of norepinephrine at the end of the intervention

  Immediately before and after each intervention

• Quantitative aspect of pain

  Immediately before and after each intervention

• Measure of the autonomic nervous system

  Immediately before, during and immediately after each intervention

• DNA in salivary sample

  Immediately after all the interventions have been completed, which will be during the second session after the pill has been ingested

Other Outcomes (5)

• Anxiety

  Immediately before each intervention

• Mood

  Immediately after the consent form has been signed, before any intervention is performed

• Pain catastrophizing

  Immediately after the consent form has been signed, before any intervention is performed

Study Arms (1)

Intervention

OTHER

Receiving the conditioned pain modulation intervention during the first session and receiving the placebo and the hypnosis or meditation interventions during the second session.

Behavioral: Hypnosis; Behavioral: Meditation; Other: Conditioned pain modulation; Drug: Placebo Oral Tablet

Interventions

Hypnosis BEHAVIORAL

Hypnosis is a therapeutic method in which the experimenter or therapist make suggestions to individuals after they have undergone a hypnotic induction. This induction is a relaxation procedure designed to focus one's mind and to induce a hypnotic trance in individuals. The hypnotic trance consists in a state of deep absorption, concentration and altered sensations, cognitions and behaviors. Hypnosis can be used for pain control in experimental and clinical settings. In this study, standardized hypnosis including a relaxation technique for the hypnotic induction and a direct hypnotic analgesia technique for the hypnotic suggestions will be used.

Also known as: Hypnotic suggestions

Intervention

Meditation BEHAVIORAL

Meditation is a relaxation method that can be used to reduce pain symptoms and pain perception in clinical and experimental situations. In this study, a standardized mindfulness meditation session of 20 minutes will be used to induce a relaxation and an analgesic effect in participants. Mindfulness meditation is a practice intended to increase mindfulness and awareness of the self and the environment by techniques of controlled breathing, focus on neutral elements, and observation of one's thoughts and emotions without judgment.

Also known as: Mindfulness meditation

Intervention

Conditioned pain modulation OTHER

Conditioned pain modulation (CPM) is a pain inhibition mechanism that is used to assess endogenous analgesia capacity. The method to evaluate CPM in healthy individuals and patients with pain includes both a conditioning stimulus (a noxious stimulus that induces CPM) and a test stimulus (a noxious stimulus used to evaluate the analgesic response to the conditioning stimulus). In this study, the conditioning stimulus will be a cold pressor test (two-minutes immersion of one hand in ice water) and the test stimulus will be a two-minutes thermal noxious stimulus delivered by a contact thermode.

Also known as: CPM, Pain modulation, Diffuse noxious inhibitory control, DNIC, Hetero-segmental counter-irritation

Intervention

Placebo Oral Tablet DRUG

A placebo is a substance (or treatment) with no active therapeutic effect. The placebo effect (analgesia) in this study will be induced by the oral administration of one inert tablet (sugar pill). The tablet is a round, hard, white, flat-faced tablet with no active ingredient. The participant is told that the tablet is an active drug, more specifically an analgesic or a painkiller, that is used to achieve analgesia, relief from pain. This placebo condition is used to induce a diffuse analgesic effect in participants.

Also known as: Placebo analgesia, Placebo effect, Placebo

Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being an healthy adult aged 18-45 years old with no prior experience of hypnosis.

You may not qualify if:

• Having difficulty understanding french language
• Having a vulnerability to dissociative or psychotic episodes
• Having a diagnosed medical condition or diagnosis of chronic pain leading to kidney, liver, dermatological, respiratory, hematological, immunological, cardiovascular, inflammatory, rheumatologic, endocrine, metabolic, neurological or psychiatric pathologies
• Being pregnant or breast-feeding
• Having a body mass index over 40
• Using medication, recreational drugs or other agents that affect the central nervous system or the perception of pain (e.g., analgesics, opioids, antiepileptics, muscle relaxers)

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

CRCHUS: Centre de recherche du centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H5N4, Canada

Location

MeSH Terms

Conditions

Agnosia; Pain

Interventions

Hypnosis; Meditation; Mindfulness; Diffuse Noxious Inhibitory Control; Placebo Effect

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Cognitive Behavioral Therapy; Analgesia; Anesthesia and Analgesia; Effect Modifier, Epidemiologic; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Serge Marchand, Ph.D.

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

• Guillaume Leonard, Ph.D.

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Repeated measures on a single group of participants

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 23, 2018
• Study Start: November 14, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 31, 2018

Record last verified: 2017-10

Locations

CA (1)