Study of the ANI Validity on Evaluation of Nociception in State of Hypnosis

University Hospital, Brest35 enrolled

Overview

Healthy subjects should assess pain on a numerical scale (EN), during painful skin stimuli of variable intensity delivered by a CO2 laser used at the power of 0.3 W, known for its safety. ANI (Analgesia Nociception Index) will be raised simultaneously. This sequence will be made on subjects at rest and in a state of hypnosis using the technique of "remembering a pleasant memory" and the ideo-sensory technique of "protective glove". The average value of the ANI will be compared to the value of the EVN of pain intensity.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

CO2 laser and ANI monitorDEVICE

Painful skin stimuli of variable intensity will be delivered by a CO2 laser used at the power of 0.3 W for each stimulation (6/phases) and this for each of the 3 phases (critical consciousness or hypnosis). During each stimulation, ANI values will be identified by the Physiodoloris ® monitor, through 3 standard ECG electrodes placed on the thorax of the subject.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Knowledge of the state of hypnosis * Healthy volunteers * Capable adults * Free and informed consent Exclusion Criteria: * Heart diseases * Medication affecting the heart rate * Medication affecting the skin sensitivity

Locations (1)

Centre Hospitalier Privé Saint-Grégoire

Saint-Grégoire, France

Outcomes

Primary Outcomes

EVN value of pain intensity versus average value of the ANI

ANI value (0 to 100, without unit of measure) recorded continuously for 60 seconds after the painful stimulation compared to the EVN value of the pain intensity, from zero to ten (numerical verval scale), and this for each of 6 painful stimuli intensities of each three consecutive phases of the study.

Time frame: ANI average value : measured continuously for 60 seconds after the painful stimulation. EVN value : raised a few seconds after the painful stimulation

Secondary Outcomes

EVN value of the arduousness of pain perception versus ANI value

EVN value of the arduousness of pain perception, from zéro to ten, for a stimulation intensity, depending on the phase of the study, compared to the ANI.

Time frame: ANI average value : measured continuously for 60 seconds after the painful stimulation. EVN value : raised a few seconds after the painful stimulation

Data from ClinicalTrials.gov

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