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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: CO2 laser and ANI monitor

• Registration Number: NCT02302313
• Lead Sponsor: University Hospital, Brest

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-11-26
• Study First Posted: 2014-11-27
• Study Start: 2015-03
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-05
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
painful stimuli	CO2 laser and ANI monitor	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".

Primary Outcome Measures

Name	Time	Method
EVN value of pain intensity versus average value of the ANI	ANI average value : measured continuously for 60 seconds after the painful stimulation. EVN value : raised a few seconds after the painful stimulation	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.

Secondary Outcome Measures

Name	Time	Method
EVN value of the arduousness of pain perception versus ANI value	ANI average value : measured continuously for 60 seconds after the painful stimulation. EVN value : raised a few seconds after the painful stimulation	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.

Trial Locations

Locations (1)

Centre Hospitalier Privé Saint-Grégoire; 🇫🇷 Saint-Grégoire, France