Study of the ANI Validity on Evaluation of Nociception in State of Hypnosis
NCT ID: NCT02302313
Last Updated: 2018-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
35 participants
INTERVENTIONAL
2015-03-31
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The average value of the ANI will be compared to the value of the EVN of pain intensity.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
ADVANCE: Assessment for Defining Variability in Anesthesia Through Novel Clinical EEG
NCT00689130
Distraction Techniques in Periocular Anesthesia: Tapping vs Vibration
NCT06355817
Stimulation and Validation of the Pupillary Dilation for the Detection of Pain in Analgosedated Patients Under Mechanically Ventilation in Intensive Care Unit
NCT04078113
International Focus Group Discussion on Neuromuscular Monitoring.
NCT06945341
Measurement of the Skin Sympathetic Nerve Activity
NCT03658057
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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".
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Healthy volunteers
* Capable adults
* Free and informed consent
Exclusion Criteria
* Medication affecting the heart rate
* Medication affecting the skin sensitivity
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Brest
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hervé MUSELLEC
Role: PRINCIPAL_INVESTIGATOR
Saint-Gregoire Private Hospital Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre Hospitalier Privé Saint-Grégoire
Saint-Grégoire, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RB 13.186 ANI-HYPNOSE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.