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

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).

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: CO2 laser and ANI monitor

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Grégoire, France, 35768
    • Centre Hospitalier Prive Saint-Gregoire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: painful stimuli; 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; 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.

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

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Hervé MUSELLEC, Saint-Gregoire Private Hospital Center

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 10, 2014
• First Submitted That Met QC Criteria: November 26, 2014
• First Posted (Estimate): November 27, 2014

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 5, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: healthy volunteers; hypnosis; Analgesia Nociception Index; numerical verbal scale; critical awareness; Determine the validity of the index (ANI); nociception in critical awareness
• Other Study ID Numbers: RB 13.186 ANI-HYPNOSE