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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).

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02302313
Enrollment
35
Registered
2014-11-27
Start date
2015-03-31
Completion date
2015-12-31
Last updated
2018-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

healthy volunteers, critical awareness, hypnosis, Analgesia Nociception Index, numerical verbal scale, Determine the validity of the index (ANI), nociception in critical awareness

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.

Interventions

DEVICECO2 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.

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
EVN value of pain intensity versus average value of the ANIANI average value : measured continuously for 60 seconds after the painful stimulation. EVN value : raised a few seconds after the painful stimulationANI 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

MeasureTime frameDescription
EVN value of the arduousness of pain perception versus ANI valueANI average value : measured continuously for 60 seconds after the painful stimulation. EVN value : raised a few seconds after the painful stimulationEVN 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026