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Clinical Trials/NCT02302313
NCT02302313
Completed
Not Applicable

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).

University Hospital, Brest1 site in 1 country35 target enrollmentMarch 2015
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
University Hospital, Brest
Enrollment
35
Locations
1
Primary Endpoint
EVN value of pain intensity versus average value of the ANI
Status
Completed
Last Updated
8 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
December 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

EVN value of pain intensity versus average value of 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

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 Outcomes

  • 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)

Study Sites (1)

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