HealthyNCT02302313
Study of the ANI Validity on Evaluation of Nociception in State of Hypnosis
A study testing CO2 laser and ANI monitor in people with Healthy, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CO2 laser and ANI monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Knowledge of the state of hypnosis
- Healthy volunteers
- Capable adults
- Free and informed consent
Who cannot join
- Heart diseases
- Medication affecting the heart rate
- Medication affecting the skin sensitivity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
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.
- Conditions
- Healthy
- Being tested
- CO2 laser and ANI monitor
- Keywords
- healthy volunteers, critical awareness, hypnosis, Analgesia Nociception Index, numerical verbal scale, Determine the validity of the index (ANI), nociception in critical awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 laser and ANI monitorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| painful stimuli | Other | 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". Receives: Device: CO2 laser and ANI monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
EVN value of pain intensity versus average value of the ANI
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.
Measured: ANI average value : measured continuously for 60 seconds after the painful stimulation. EVN value : raised a few seconds after the painful stimulation
Secondary outcomes (1)
EVN value of the arduousness of pain perception versus ANI value
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.
Measured: ANI average value : measured continuously for 60 seconds after the painful stimulation. EVN value : raised a few seconds after the painful stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé MUSELLEC, Principal investigator, Saint-Gregoire Private Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302313
- Sponsor's protocol ID
- RB 13.186 ANI-HYPNOSE
- Status last verified
- Jan 2018
- First submitted
- 10 Sep 2014
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT02302313
- Acronym / sponsor ID
- RB 13.186 ANI-HYPNOSE
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| painful stimuli | Other | Device: CO2 laser and ANI monitorNo 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". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Knowledge of the state of hypnosis
- Healthy volunteers
- Capable adults
- Free and informed consent
Key exclusion criteria (3 listed)
- Heart diseases
- Medication affecting the heart rate
- Medication affecting the skin sensitivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2 laser and ANI monitorPainful 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. | Device | painful stimuli |
Primary outcome
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.
1 secondary outcome
EVN value of the arduousness of pain perception versus ANI value
Time frame: ANI average value : measured continuously for 60 seconds after the painful stimulation. EVN value : raised a few seconds after the painful stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hervé MUSELLEC principal investigator
Saint-Gregoire Private Hospital Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 laser and ANI monitor in people with Healthy, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2018.