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HypnosisNCT03407937

The Effect of Hypnosis on Blood Concentrations of Endocannabinoids

A study testing Hypnosis, Meditation and Conditioned pain modulation in people with Hypnosis and Endocannabinoids, run by Université de Sherbrooke at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Hypnosis, Endocannabinoids, Analgesia
What is being tested?
Hypnosis, Meditation and Conditioned pain modulation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
1 siteCanada
Study dates
14 Nov 2017to 1 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • CRCHUS: Centre de recherche du centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H5N4

Other trials in Canada

About this study

Official title: The Role of the Endocannabinoids During the Analgesia Caused by Hypnosis and Meditation

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.

Being tested
Hypnosis, Meditation, Conditioned pain modulation, Placebo Oral Tablet
Keywords
Hypnosis, Meditation, Conditioned pain modulation, Placebo, Endocannabinoids, Opioid peptides, Norepinephrine, Pain, Analgesia, Genes, Heart rate variability
Medical subject headings
Agnosia, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HypnosisBehavioural

    Also called Hypnotic suggestions

    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.

  • MeditationBehavioural

    Also called Mindfulness meditation

    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.

  • Conditioned pain modulationOther

    Also called CPM, Pain modulation, Diffuse noxious inhibitory control, DNIC

    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.

  • Placebo Oral TabletDrug

    Also called Placebo analgesia, Placebo effect, Placebo

    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.

Study groups in NCT03407937
Study groupRoleWhat they receive
InterventionOtherReceiving the conditioned pain modulation intervention during the first session and receiving the placebo and the hypnosis or meditation interventions during the second session.
Receives: Behavioral: Hypnosis; Behavioral: Meditation; Other: Conditioned pain modulation; Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Immediately before and after each intervention

Secondary outcomes (5)

  1. Change from baseline concentrations of opioids at the end of the intervention

    Concentrations (ng/ml) of opioids (beta-endorphins, met/leu-enkephalins, and dynorphins) will be measured in the plasma of participants

    Measured: Immediately before and after each intervention

  2. Change from baseline concentrations of norepinephrine at the end of the intervention

    Concentrations (ng/ml) of norepinephrine will be measured in the plasma of participants

    Measured: Immediately before and after each intervention

  3. Quantitative aspect of pain

    Quantitative aspect of pain, or pain intensity, will be measured and averaged for the entire duration (two minutes) of the pain tests on a Computerized Visual Analog Scale (CoVAS). This CoVAS scale ranges from 0% to 100%. Higher values on this scale represent more intense pain.

    Measured: Immediately before and after each intervention

  4. Measure of the autonomic nervous system

    This outcome will be measured by heart rate variability

    Measured: Immediately before, during and immediately after each intervention

  5. DNA in salivary sample

    DNA polymorphisms potentially associated with analgesia, endocannabinoids, opioids or norepinephrine

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2018
  2. Study start14 Nov 2017
  3. Primary completion1 Sep 2018
  4. Study completion1 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
Repeated measures on a single group of participants
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03407937
Sponsor's protocol ID
2017-1477
Status last verified
Oct 2017
First submitted
8 Jan 2018
Last updated
31 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Hypnosis, Meditation and Conditioned pain modulation in people with Hypnosis and Endocannabinoids, run by Université de Sherbrooke at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline concentration of endocannabinoids at the end of the intervention (time frame: Immediately before and after each intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03407937.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.

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