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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Pilot Study of the ANI (Analgesia Nociception Index) Validity on the Nociception Assessment in Healthy Volunteers in State of Hypnosis, Compared to Painful Numerical Verbal Scale (EVN).

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: CO2 laser and ANI monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: painful stimuli<br>No drug and no placebo will be used in this study. The study participants will only rate their pain on a numerical scale (EN) following cutaneous painful stimulation (6 for each phase) of variable intensity, delivered by a CO2 laser. ANI (Analgesia Nociception Index) will be raised simultaneously by the ANI monitor. This sequence will be performed on subjects at rest and in a state of hypnosis by the technique of remembering a pleasant memory and the ideo-sensory technique of protective glove. | Device: CO2 laser and ANI monitor<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | ANI average value : measured continuously for 60 seconds after the painful stimulation. EVN value : raised a few seconds after the painful stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | ANI average value : measured continuously for 60 seconds after the painful stimulation. EVN value : raised a few seconds after the painful stimulation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy volunteers, critical awareness, hypnosis, Analgesia Nociception Index, numerical verbal scale, Determine the validity of the index (ANI), nociception in critical awareness