<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/NCT04423874</url>
  </required_header>
  <id_info>
    <org_study_id>19CH215</org_study_id>
    <secondary_id>2020-A00274-35</secondary_id>
    <nct_id>NCT04423874</nct_id>
  </id_info>
  <brief_title>The Effect of Exposure to Aversive Non-verbal Vocalizations on Pain Tolerance</brief_title>
  <acronym>CRYPAIN</acronym>
  <official_title>The Effect of Exposure to Aversive Non-verbal Vocalizations on Pain Tolerance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Laboratoire ENES-CNPS (Université Lyon/Saint Etienne)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Humans produce non-verbal vocalizations (shouting, growling, screaming), laughter, ...) in&#xD;
      various contexts that are likely to perform biological functions.&#xD;
&#xD;
      and important social issues. Yet despite their importance in the human vocal repertoire, the&#xD;
      mechanisms and functions of non-verbal vocalizations remain little studied and poorly&#xD;
      understood including in humans.&#xD;
&#xD;
      In this context, the investigators wish to examine how the perception of vocalizations&#xD;
      non-verbal aversive behaviours influence pain tolerance in healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Humans produce nonverbal vocalisations such as screams, grunts, roars, cries and laughter&#xD;
      across a variety of contexts. Yet despite the prominence and apparent importance of these&#xD;
      nonverbal sounds in human communication, the investigators still know very little about their&#xD;
      influence on human perception and behaviour. That's why, in this study, the investigators&#xD;
      will examine specifically the influence of nonverbal vocal perception on pain tolerance.&#xD;
&#xD;
      The remainder of the study will involve up to three trials of a pain tolerance (cold pressor)&#xD;
      task, during which the investigators will ask participants to listen to vocalisations (e.g.,&#xD;
      babies' cries or babbling) while submerging the participant's hand in bath of circulating&#xD;
      cold water.&#xD;
&#xD;
      The results of the study will contribute to theoretical understanding of the functions of&#xD;
      nonverbal vocal communication in humans, in particular the influence of nonverbal vocal and&#xD;
      perception (of babies' cries) on pain tolerance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 25, 2022</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain tolerance</measure>
    <time_frame>at inclusion</time_frame>
    <description>Delay (in seconds) in removing the hand when testing the Cold Pressor.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Onset of pain</measure>
    <time_frame>at inclusion</time_frame>
    <description>Participant verbally indicates when he or she begins to feel the sensation of pain (time of onset measured in seconds).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>at inclusion</time_frame>
    <description>Subjective assessment of maximum pain intensity by participants for a given trial.&#xD;
Measured by scale of 0 (no pain) at 100 (extreme pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between NOL index and video pupillometry results</measure>
    <time_frame>at inclusion</time_frame>
    <description>Measurement of the NOL index (index ranging from 0 to 100) and measurement of pupillary diameter and its variations (in mm) in response to nociceptive stimuli by video pupillometry.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">104</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Healthy adult population aged 18 to 60 years.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Their pain tolerance will be tested using the Cold Pressor Task while listening to vocalisations. Physiological measures will be taken using two techniques: Nociception Level Index and video pupillometry.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cold pressor task (CPT)</intervention_name>
    <description>The cold pressor test is among the most common and established methods for studying human reactions to pain and pain tolerance.&#xD;
Participants submerge a hand in cold water (approx. 5°C) and are asked to keep their hand submerged for as long as can (until the sensation is intolerable), up to a maximum of 5 min.&#xD;
The procedure is safe because the hand is removed before adverse effects can occur.&#xD;
The participant will be given a break of 5 min in between trials, and will interchange hands between trials.&#xD;
During this break hand may to be place in warm water (25-35°C) for up to 4 min to normalise hand temperature, which will be measured before and after each trial using a digital thermometer held firmly in the palm of the hand. Each participant will complete no more than three trials (conditions) in a randomised order.</description>
    <arm_group_label>Healthy adult population aged 18 to 60 years.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>index NOL</intervention_name>
    <description>Measurement of the index NOL™: Four sensors, placed non-invasively on one of the four participants' fingers, will make it possible to calculate a dozen physiological parameters converts in real time into a pain index called NOL (for Nociception Level Index).</description>
    <arm_group_label>Healthy adult population aged 18 to 60 years.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Playback Experiments</intervention_name>
    <description>During the experience, participants are led to listen, via headphones, to aversive non-verbal vocalizations (baby crying). The sound levels used to broadcast the non-verbal vocalisations will be scrupulously measured using approved and certified equipment during the preparation of the experiments. These sound volumes will be chosen so as not to inconvenience participants.</description>
    <arm_group_label>Healthy adult population aged 18 to 60 years.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Video-pupillometry</intervention_name>
    <description>This technique is based on the observation of the dilatation of the pupil during the perception of a nociceptive stimulus in test persons.</description>
    <arm_group_label>Healthy adult population aged 18 to 60 years.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant in good health&#xD;
&#xD;
          -  Affiliated or entitled participant in a social security scheme&#xD;
&#xD;
          -  Participant who received informed information about the study and co-signed, with the&#xD;
             investigator, a consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic pain&#xD;
&#xD;
          -  High blood pressure or poor circulation&#xD;
&#xD;
          -  Cardiac or vascular disease, or a heart condition (including symptoms of Raynaud's&#xD;
             syndrome)&#xD;
&#xD;
          -  Allergy or hypersensitivity to cold&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Recent serious injury&#xD;
&#xD;
          -  Neurological or psychiatric condition known to affect pain tolerance (e.g., peripheral&#xD;
             neuropathy, schizophrenia)&#xD;
&#xD;
          -  History of fainting or seizures&#xD;
&#xD;
          -  History of frostbite&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roland PEYRON, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU SAINT-ETIENNE</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Roland PEYRON, MD</last_name>
    <phone>(0)477127805</phone>
    <phone_ext>+33</phone_ext>
    <email>roland.peyron@chu-st-etienne.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hélène RAINGARD, CRA</last_name>
    <phone>(0)4.77.82.97.03</phone>
    <phone_ext>+33</phone_ext>
    <email>helene.raingard@chu-st-etienne.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire SAINT-ETIENNE</name>
      <address>
        <city>Saint-Étienne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Roland PEYRON, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kasia PISANSKI, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Clément CORNEC, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>nonverbal vocal communication</keyword>
  <keyword>babies cries</keyword>
  <keyword>pain tolerance</keyword>
  <keyword>cold pressor test</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/NCT04423874
org study id: 19CH215
secondary id: 2020-A00274-35
nct id: NCT04423874
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Humans produce non-verbal vocalizations (shouting, growling, screaming), laughter, ...) in
      various contexts that are likely to perform biological functions.

      and important social issues. Yet despite their importance in the human vocal repertoire, the
      mechanisms and functions of non-verbal vocalizations remain little studied and poorly
      understood including in humans.

      In this context, the investigators wish to examine how the perception of vocalizations
      non-verbal aversive behaviours influence pain tolerance in healthy adults.
Humans produce nonverbal vocalisations such as screams, grunts, roars, cries and laughter
      across a variety of contexts. Yet despite the prominence and apparent importance of these
      nonverbal sounds in human communication, the investigators still know very little about their
      influence on human perception and behaviour. That's why, in this study, the investigators
      will examine specifically the influence of nonverbal vocal perception on pain tolerance.

      The remainder of the study will involve up to three trials of a pain tolerance (cold pressor)
      task, during which the investigators will ask participants to listen to vocalisations (e.g.,
      babies' cries or babbling) while submerging the participant's hand in bath of circulating
      cold water.

      The results of the study will contribute to theoretical understanding of the functions of
      nonverbal vocal communication in humans, in particular the influence of nonverbal vocal and
      perception (of babies' cries) on pain tolerance.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pain tolerance
time frame: at inclusion
description: Delay (in seconds) in removing the hand when testing the Cold Pressor.
measure: Onset of pain
time frame: at inclusion
description: Participant verbally indicates when he or she begins to feel the sensation of pain (time of onset measured in seconds).
measure: Pain intensity
time frame: at inclusion
description: Subjective assessment of maximum pain intensity by participants for a given trial.
Measured by scale of 0 (no pain) at 100 (extreme pain).
measure: Correlation between NOL index and video pupillometry results
time frame: at inclusion
description: Measurement of the NOL index (index ranging from 0 to 100) and measurement of pupillary diameter and its variations (in mm) in response to nociceptive stimuli by video pupillometry.
arm group label: Healthy adult population aged 18 to 60 years.
arm group type: Experimental
description: Their pain tolerance will be tested using the Cold Pressor Task while listening to vocalisations. Physiological measures will be taken using two techniques: Nociception Level Index and video pupillometry.
intervention type: Behavioral
intervention name: Cold pressor task (CPT)
description: The cold pressor test is among the most common and established methods for studying human reactions to pain and pain tolerance.
Participants submerge a hand in cold water (approx. 5°C) and are asked to keep their hand submerged for as long as can (until the sensation is intolerable), up to a maximum of 5 min.
The procedure is safe because the hand is removed before adverse effects can occur.
The participant will be given a break of 5 min in between trials, and will interchange hands between trials.
During this break hand may to be place in warm water (25-35°C) for up to 4 min to normalise hand temperature, which will be measured before and after each trial using a digital thermometer held firmly in the palm of the hand. Each participant will complete no more than three trials (conditions) in a randomised order.
arm group label: Healthy adult population aged 18 to 60 years.
intervention type: Diagnostic Test
intervention name: index NOL
description: Measurement of the index NOL™: Four sensors, placed non-invasively on one of the four participants' fingers, will make it possible to calculate a dozen physiological parameters converts in real time into a pain index called NOL (for Nociception Level Index).
arm group label: Healthy adult population aged 18 to 60 years.
intervention type: Behavioral
intervention name: Playback Experiments
description: During the experience, participants are led to listen, via headphones, to aversive non-verbal vocalizations (baby crying). The sound levels used to broadcast the non-verbal vocalisations will be scrupulously measured using approved and certified equipment during the preparation of the experiments. These sound volumes will be chosen so as not to inconvenience participants.
arm group label: Healthy adult population aged 18 to 60 years.
intervention type: Diagnostic Test
intervention name: Video-pupillometry
description: This technique is based on the observation of the dilatation of the pupil during the perception of a nociceptive stimulus in test persons.
arm group label: Healthy adult population aged 18 to 60 years.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Roland PEYRON, MD
role: Principal Investigator
affiliation: CHU SAINT-ETIENNE
last name: Roland PEYRON, MD
phone: (0)477127805
phone ext: +33
email: roland.peyron@chu-st-etienne.fr
last name: Hélène RAINGARD, CRA
phone: (0)4.77.82.97.03
phone ext: +33
email: helene.raingard@chu-st-etienne.fr
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
sharing ipd: No