<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/NCT03250871</url>
  </required_header>
  <id_info>
    <org_study_id>2017-A01936-47</org_study_id>
    <nct_id>NCT03250871</nct_id>
  </id_info>
  <brief_title>Hypnosis in Interventional Electrophysiology</brief_title>
  <acronym>PAINLESS</acronym>
  <official_title>Hypnosis Contribution to Interventional Electrophysiology Performed Under Local Anesthesia and Morphine Titration Study PAINLESS : Does Hypnosis Reduce Pain in Electrophysiology Procedures ?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poitiers University Hospital</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>
      Hypnosis has already shown to decrease pain and anxiety in different surgical specialities.&#xD;
      Nevertheless, its input has never been studied in cardiology. This research is a prospective,&#xD;
      monocentric, controlled and randomized study.&#xD;
&#xD;
      Patients over 18 years old and hospitalized for atrial flutter ablation may be included and&#xD;
      randomized into one of the arms: placebo or hypnosis.&#xD;
&#xD;
      Global pain will be assessed by a visual analogue pain scale. Anxiety, morphine consumption,&#xD;
      and patient sedation will also be assessed.&#xD;
&#xD;
      The aim of this study is to improve the care given to patient undergoing atrial flutter&#xD;
      ablation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">September 26, 2019</completion_date>
  <primary_completion_date type="Actual">September 23, 2019</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Global pain self-assessment during the procedure</measure>
    <time_frame>Collected 45 min after the procedure</time_frame>
    <description>Assessed with visual analogue pain scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety during the procedure</measure>
    <time_frame>Collected after the procedure</time_frame>
    <description>Visual analog scale self-assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morphine consumption</measure>
    <time_frame>Collected after the procedure</time_frame>
    <description>milligram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient sedation evaluation</measure>
    <time_frame>Collected after the procedure</time_frame>
    <description>numerical rating scale; Externally assessed by the electrophysiologist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessed prospectively during the procedure;</measure>
    <time_frame>Evaluated every 5 minutes during the procedure;</time_frame>
    <description>Numerical rating scale score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">116</enrollment>
  <condition>Flutter, Atrial</condition>
  <condition>Over 18 Years Old</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo will be the suggestion of self-relaxation methods (for example, &quot;try to relax&quot; ,&quot;try to think of pleasant moment &quot;) and the diffusion of &quot;white noise&quot; during surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypnosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hypnosis will be associated with the usual anesthesia. Hypnosis is a temporary modification of consciousness technique based on suggestion.&#xD;
It is divided into three phases:&#xD;
induction: attention of the patient fixed on an object or a part of the body,&#xD;
the dissociation where the patient cuts off auditory, visual and tactile perceptions,&#xD;
and finally the opening towards a hypnotic experience thanks to the imaginary.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hypnosis</intervention_name>
    <description>Hypnosis will be supervised by a nurse trained by the French Institute of Hypnosis.</description>
    <arm_group_label>Hypnosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo consists in non-hypnotic relaxation suggestions and in hearing white noise through headphones</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18 years old&#xD;
&#xD;
          -  Surgery ablation of atrial flutter&#xD;
&#xD;
          -  Agreement to participate of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Person who does not speak French or deaf&#xD;
&#xD;
          -  Chronic pain with the visual analogue scale &gt; 5&#xD;
&#xD;
          -  Psychiatric pathology&#xD;
&#xD;
          -  Contraindication to paracetamol, lidocaine, morphine&#xD;
&#xD;
          -  Pregnant women, or breast-feeding women or without effective contraception&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU DE Poitiers</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>February 6, 2020</last_update_submitted>
  <last_update_submitted_qc>February 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Flutter</mesh_term>
  </condition_browse>
  <!-- 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/NCT03250871
org study id: 2017-A01936-47
nct id: NCT03250871
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Hypnosis has already shown to decrease pain and anxiety in different surgical specialities.
      Nevertheless, its input has never been studied in cardiology. This research is a prospective,
      monocentric, controlled and randomized study.

      Patients over 18 years old and hospitalized for atrial flutter ablation may be included and
      randomized into one of the arms: placebo or hypnosis.

      Global pain will be assessed by a visual analogue pain scale. Anxiety, morphine consumption,
      and patient sedation will also be assessed.

      The aim of this study is to improve the care given to patient undergoing atrial flutter
      ablation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Global pain self-assessment during the procedure
time frame: Collected 45 min after the procedure
description: Assessed with visual analogue pain scale
measure: Anxiety during the procedure
time frame: Collected after the procedure
description: Visual analog scale self-assessment
measure: Morphine consumption
time frame: Collected after the procedure
description: milligram
measure: Patient sedation evaluation
time frame: Collected after the procedure
description: numerical rating scale; Externally assessed by the electrophysiologist
measure: Pain assessed prospectively during the procedure;
time frame: Evaluated every 5 minutes during the procedure;
description: Numerical rating scale score
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo will be the suggestion of self-relaxation methods (for example, "try to relax" ,"try to think of pleasant moment ") and the diffusion of "white noise" during surgery.
arm group label: Hypnosis
arm group type: Experimental
description: Hypnosis will be associated with the usual anesthesia. Hypnosis is a temporary modification of consciousness technique based on suggestion.
It is divided into three phases:
induction: attention of the patient fixed on an object or a part of the body,
the dissociation where the patient cuts off auditory, visual and tactile perceptions,
and finally the opening towards a hypnotic experience thanks to the imaginary.
intervention type: Other
intervention name: Hypnosis
description: Hypnosis will be supervised by a nurse trained by the French Institute of Hypnosis.
arm group label: Hypnosis
intervention type: Other
intervention name: Placebo
description: Placebo consists in non-hypnotic relaxation suggestions and in hearing white noise through headphones
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Atrial Flutter