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

R

Regional University Hospital Center (CHRU)

Status

Completed

Conditions

Healthy

Treatments

Device: CO2 laser and ANI monitor

Study type

Interventional

Funder types

Other

Identifiers

NCT02302313
RB 13.186 ANI-HYPNOSE

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Single Blind

35 participants in 1 patient group

painful stimuli
Other group
Description:
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".
Treatment:
Device: CO2 laser and ANI monitor

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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