<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/NCT03773198</url>
  </required_header>
  <id_info>
    <org_study_id>DAUVERGNE APPARA 2017</org_study_id>
    <nct_id>NCT03773198</nct_id>
  </id_info>
  <brief_title>Effectiveness of Energy Resonance by Skin Stimulation in the Management of Anxious Patients Who Require Scheduled Orthopaedic Surgery</brief_title>
  <acronym>ERESCAO</acronym>
  <official_title>Effectiveness of Energy Resonance by Skin Stimulation in the Management of Anxious Patients Who Require Scheduled Orthopaedic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The need for a surgical procedure may cause a patient to experience reactive anxiety. This&#xD;
      reaction is appropriate if it is of low to moderate intensity. On the other hand, various&#xD;
      studies have shown that postoperative awakening is more complicated if the patient&#xD;
      experiences major preoperative anxiety. Thus, reducing anxiety could be a tool for preventing&#xD;
      chronic pain.&#xD;
&#xD;
      For several years now, the investigator's facility has been implementing Energy Resonance&#xD;
      through Cutaneous Stimulation (ERCS), a method based on &quot;listening&quot; to the body's vibrations&#xD;
      through the fingers on points based on the mapping of meridians in Chinese medicine.&#xD;
&#xD;
      ERCS practitioners have noted the benefits of this method, particularly in soothing patients.&#xD;
      It therefore seems necessary to detect and manage this anxiety beforehand and ERCS seems&#xD;
      appropriate in this situation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 5, 2019</start_date>
  <completion_date type="Anticipated">March 2022</completion_date>
  <primary_completion_date type="Anticipated">October 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>anxiety-state</measure>
    <time_frame>During the surgical procedure</time_frame>
    <description>Evolution of the patient's anxiety, between the entry and exit of the surgical department measured by the Spielberger state anxiety inventory, which is intended to evaluate an emotional reaction at a given time represented here by the operating room.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">86</enrollment>
  <condition>Patient Requiring Scheduled Conventional Orthopedic Surgical Intervention of the Upper or Lower Limb</condition>
  <arm_group>
    <arm_group_label>ERCS Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Energy Resonance through Cutaneous Stimulation</intervention_name>
    <description>The ERCS method involves &quot;listening&quot; to the body by applying fingers to the acupuncture skin points, developed according to the energy imbalance caused by illness, pain and emotional disorders.</description>
    <arm_group_label>ERCS Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaires</intervention_name>
    <description>Measurement of anxiety-trait and state-anxiety (Spielberger), pain ( numerical scale) and satisfaction (numerical satisfaction scale)</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>ERCS Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient who has given oral consent&#xD;
&#xD;
          -  Adult patient requiring scheduled conventional orthopedic surgery of the upper limb&#xD;
             (wrist, elbow, shoulder) or lower limb (ankle, foot, knee, hip)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient not affiliated to a national health insurance system,&#xD;
&#xD;
          -  Patient subject to a legal protection measure (curatorship, guardianship)&#xD;
&#xD;
          -  Patient subject to a justice protection measure&#xD;
&#xD;
          -  Pregnant, parturient or breastfeeding woman&#xD;
&#xD;
          -  Patient unable to give consent&#xD;
&#xD;
          -  Minor&#xD;
&#xD;
          -  Patient with a pace maker&#xD;
&#xD;
          -  Patient with cognitive problems: Alzheimer's, senile dementia&#xD;
&#xD;
          -  Patient who has already received ERCS as part of surgery&#xD;
&#xD;
          -  Patient who does not speak or understand French&#xD;
&#xD;
          -  Patient with psychiatric disorders: major depression, bipolar disorder, addictive&#xD;
             disorders, psychotic disorders (psychosis, schizophrenia, acute delirium)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Isabelle DAUVERGNE</last_name>
    <phone>+33 385818490</phone>
    <email>isabelle.dauvergne@ch-paray.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu Dijon Bourogne</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Isabelle DAUVERGNE</last_name>
      <phone>+33 385818490</phone>
      <email>isabelle.dauvergne@ch-paray.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>May 13, 2019</last_update_submitted>
  <last_update_submitted_qc>May 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03773198
org study id: DAUVERGNE APPARA 2017
nct id: NCT03773198
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The need for a surgical procedure may cause a patient to experience reactive anxiety. This
      reaction is appropriate if it is of low to moderate intensity. On the other hand, various
      studies have shown that postoperative awakening is more complicated if the patient
      experiences major preoperative anxiety. Thus, reducing anxiety could be a tool for preventing
      chronic pain.

      For several years now, the investigator's facility has been implementing Energy Resonance
      through Cutaneous Stimulation (ERCS), a method based on "listening" to the body's vibrations
      through the fingers on points based on the mapping of meridians in Chinese medicine.

      ERCS practitioners have noted the benefits of this method, particularly in soothing patients.
      It therefore seems necessary to detect and manage this anxiety beforehand and ERCS seems
      appropriate in this situation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: anxiety-state
time frame: During the surgical procedure
description: Evolution of the patient's anxiety, between the entry and exit of the surgical department measured by the Spielberger state anxiety inventory, which is intended to evaluate an emotional reaction at a given time represented here by the operating room.
arm group label: ERCS Group
arm group type: Experimental
arm group label: Control Group
arm group type: Placebo Comparator
intervention type: Other
intervention name: Energy Resonance through Cutaneous Stimulation
description: The ERCS method involves "listening" to the body by applying fingers to the acupuncture skin points, developed according to the energy imbalance caused by illness, pain and emotional disorders.
arm group label: ERCS Group
intervention type: Other
intervention name: questionnaires
description: Measurement of anxiety-trait and state-anxiety (Spielberger), pain ( numerical scale) and satisfaction (numerical satisfaction scale)
arm group label: Control Group
arm group label: ERCS Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Isabelle DAUVERGNE
phone: +33 385818490
email: isabelle.dauvergne@ch-paray.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor