<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02971852</url>
  </required_header>
  <id_info>
    <org_study_id>Hypnotic glove anesthesia</org_study_id>
    <nct_id>NCT02971852</nct_id>
  </id_info>
  <brief_title>Effects of Hypnosis on Skin Temperature</brief_title>
  <official_title>Hypnotic Glove Anesthesia: Effects of Hypnosis on Skin Temperature Measured by Infrared Thermography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Claude Bernard University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre Clinical, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Saint-Gregoire Private Hospital Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut Émergences, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Claude Bernard University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypnotic glove anesthesia is a hypnosis technique wherein the patient, following the&#xD;
      suggestions of the hypnotherapist, is mentally capable to create a loss of sensation in areas&#xD;
      of the hand that would be covered by a glove. We investigated the effects of hypnotic glove&#xD;
      anesthesia on skin temperature measured by thermography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After 20 min installation and temperature equilibration (T0), the subject skin temperature&#xD;
      was recorded in 5 regions of both hands (1 = distal hand, 2 = proximal hand, 3 = wrist, 4 =&#xD;
      distal forearm, 5 = proximal forearm) using infrared thermography.&#xD;
&#xD;
      After 10 min of latency, skin temperature was recorded again in both hands (T1).&#xD;
&#xD;
      A first noxious stimulus (NOX1) is then applied by the hypnotherapist by pinching the webbing&#xD;
      between the thumb and index fingers of the dominant hand between the thumb and the index.&#xD;
      Pain intensity is assessed on a 0-10 (0 = no pain, 10 = maximal pain imaginable) numerical&#xD;
      rating scale (NRS1).&#xD;
&#xD;
      The hypnotic glove is then mentally created by the subject on his dominant hand following the&#xD;
      suggestions of the hypnotherapist (T2). To assess the efficacy of the hypnotic glove, a&#xD;
      second noxious stimulus (NOX2) is applied similarly to NOX1 and the NRS was recorded (NRS2).&#xD;
&#xD;
      The subject is then invited to mentally wear off the glove (T3). Skin temperature is then&#xD;
      recorded in both hands, and a third noxious stimulus (NOX3) is applied similarly to NOX1 and&#xD;
      NOX2 to verify the disappearance of hypnotic anesthesia.&#xD;
&#xD;
      A last record of skin temperature in both hands is performed 5 min after the glove is&#xD;
      withdrawn (T4).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in skin temperature during the experiment in the hand and forearm</measure>
    <time_frame>During the study experiment, from the beginning of the experiment, after 20 min installation and temperature equilibration, to the end of the experiment, 5 min after the glove is mentally withdrawn (approximately 1 h).</time_frame>
    <description>Comparison of skin temperature between the dominant (&quot;wearing&quot; the hypnotic glove) and the non-dominant hand and forearm in the 5 predefined regions from Time 0 to Time 4.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in pain intensity during the experiment following noxious stimulation</measure>
    <time_frame>During the study experiment, from 10 min after the beginning of the experiment to 5 min before the end of the experiment, when the glove is mentally withdrawn (approximately 45 min).</time_frame>
    <description>Comparison of pain intensity following noxious stimulation assessed by 0-10 NRS scale at Time 1, Time 2 and Time 3 in the dominant hand (&quot;wearing&quot; the hypnotic glove).</description>
  </secondary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Hypnosis</condition>
  <condition>Healthy Volunteers</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers aged from 18 to 75&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurologic or psychiatric disorder&#xD;
&#xD;
          -  Upper limb amputation&#xD;
&#xD;
          -  Microcirculation abnormalities (e.g. Raynaud syndrome)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xavier Paqueron, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Clinical, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Émergences</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier privé Saint-Grégoire</name>
      <address>
        <city>Saint-Grégoire</city>
        <zip>35768</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Clinical</name>
      <address>
        <city>Soyaux</city>
        <zip>16800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>July 18, 2017</last_update_submitted>
  <last_update_submitted_qc>July 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Claude Bernard University</investigator_affiliation>
    <investigator_full_name>Emmanuel Boselli</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Hypnosis</keyword>
  <keyword>Anesthesia</keyword>
  <keyword>Suggestion</keyword>
  <keyword>Thermography</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02971852
org study id: Hypnotic glove anesthesia
nct id: NCT02971852
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Hypnotic glove anesthesia is a hypnosis technique wherein the patient, following the
      suggestions of the hypnotherapist, is mentally capable to create a loss of sensation in areas
      of the hand that would be covered by a glove. We investigated the effects of hypnotic glove
      anesthesia on skin temperature measured by thermography.
After 20 min installation and temperature equilibration (T0), the subject skin temperature
      was recorded in 5 regions of both hands (1 = distal hand, 2 = proximal hand, 3 = wrist, 4 =
      distal forearm, 5 = proximal forearm) using infrared thermography.

      After 10 min of latency, skin temperature was recorded again in both hands (T1).

      A first noxious stimulus (NOX1) is then applied by the hypnotherapist by pinching the webbing
      between the thumb and index fingers of the dominant hand between the thumb and the index.
      Pain intensity is assessed on a 0-10 (0 = no pain, 10 = maximal pain imaginable) numerical
      rating scale (NRS1).

      The hypnotic glove is then mentally created by the subject on his dominant hand following the
      suggestions of the hypnotherapist (T2). To assess the efficacy of the hypnotic glove, a
      second noxious stimulus (NOX2) is applied similarly to NOX1 and the NRS was recorded (NRS2).

      The subject is then invited to mentally wear off the glove (T3). Skin temperature is then
      recorded in both hands, and a third noxious stimulus (NOX3) is applied similarly to NOX1 and
      NOX2 to verify the disappearance of hypnotic anesthesia.

      A last record of skin temperature in both hands is performed 5 min after the glove is
      withdrawn (T4).
observational model: Cohort
time perspective: Prospective
measure: Change in skin temperature during the experiment in the hand and forearm
time frame: During the study experiment, from the beginning of the experiment, after 20 min installation and temperature equilibration, to the end of the experiment, 5 min after the glove is mentally withdrawn (approximately 1 h).
description: Comparison of skin temperature between the dominant ("wearing" the hypnotic glove) and the non-dominant hand and forearm in the 5 predefined regions from Time 0 to Time 4.
measure: Change in pain intensity during the experiment following noxious stimulation
time frame: During the study experiment, from 10 min after the beginning of the experiment to 5 min before the end of the experiment, when the glove is mentally withdrawn (approximately 45 min).
description: Comparison of pain intensity following noxious stimulation assessed by 0-10 NRS scale at Time 1, Time 2 and Time 3 in the dominant hand ("wearing" the hypnotic glove).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xavier Paqueron, MD, PhD
role: Principal Investigator
affiliation: Centre Clinical, France
facility: 
facility: 
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Claude Bernard University
investigator full name: Emmanuel Boselli
investigator title: MD, PhD
sharing ipd: No