<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/NCT03273816</url>
  </required_header>
  <id_info>
    <org_study_id>35RC16_9805</org_study_id>
    <nct_id>NCT03273816</nct_id>
  </id_info>
  <brief_title>Evaluation of the Benefit Provided by Sessions of Sophrology on the Per Operative Management of Parkinsonian Patients Planned for a Deep Brain Stimulation Surgery.</brief_title>
  <acronym>SOPHROSTIM</acronym>
  <official_title>Evaluation of the Benefit Provided by Sessions of Sophrology on the Intraoperative Management of Parkinsonian Patients in the Context of Deep Brain Stimulation Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      Deep brain stimulation surgery, which consists of intracerebral implantation of electrodes,&#xD;
      is considered one of the most effective techniques for controlling the motor fluctuations of&#xD;
      Parkinson's disease. The particularity of this surgery is the necessity of the awakening of&#xD;
      the patient for the correct positioning of the electrodes, it is therefore a difficult test&#xD;
      for the patient.&#xD;
&#xD;
      Medical sophrology is an ideal strategy to optimize the comfort of the patient during the&#xD;
      operation thanks to its anxiolytic and analgesic virtues while guaranteeing the maintenance&#xD;
      of a good patient vigilance favoring the cooperation with the operating room team. Indeed,&#xD;
      sophrology is a body-mediated set of techniques, at the crossroads between hypnosis and yoga,&#xD;
      which makes it possible to find a balance between emotions, thoughts and behaviors. It has&#xD;
      already been applied in other fields such as oncology, pain management, preparation for&#xD;
      childbirth, and for 5 years at the CHU of Rennes for preparation for the intervention of deep&#xD;
      brain stimulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    insufficient recruitment rate&#xD;
  </why_stopped>
  <start_date type="Actual">December 14, 2017</start_date>
  <completion_date type="Actual">March 1, 2022</completion_date>
  <primary_completion_date type="Actual">February 22, 2022</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>
    <intervention_model_description>Randomized, controlled, bi-centric (national), superiority, open-label, blind-blind (evaluator) trial comparing sophrology to routine care in preparation for deep brain stimulation. The distribution of patients will be balanced between the two groups.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The primary endpoint is taken by a nurse who does not know the randomization arm.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Patient anxiety</measure>
    <time_frame>at one hour after the beginning of the intervention</time_frame>
    <description>patient anxiety evaluated by the STAI-YA (State Trait Anxiety Inventory), retranscribed by a caregiver of the block, the patient being unable in practice to fill in a questionnaire at that time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Per operative pain</measure>
    <time_frame>intraoperative (at the beginning of the intervention)</time_frame>
    <description>Per operative pain judged by a visual scale analogous</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Per operative pain</measure>
    <time_frame>at one hour after the begginnig of the intervention</time_frame>
    <description>Per operative pain judged by a visual scale analogous</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Per operative pain</measure>
    <time_frame>Intraoperative (At the end of the first electrode placement)</time_frame>
    <description>Per operative pain judged by a visual scale analogous</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the anxiety</measure>
    <time_frame>At one hour before the procedure</time_frame>
    <description>Evaluation of the anxiety measured by the STAI YA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the anxiety</measure>
    <time_frame>Intraoperative (At the end of the first electrode placement)</time_frame>
    <description>Evaluation of the anxiety measured by the STAI YA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interaction between the patient and the surgical team during the procedure</measure>
    <time_frame>At Day 0</time_frame>
    <description>interaction is judged by a visual analogue scale to be completed by the neurologist and the neurosurgeon</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The duration of the intervention in minutes</measure>
    <time_frame>intraoperative</time_frame>
    <description>The duration of the intervention in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>At one hour after the beginning of the intervention</time_frame>
    <description>Heart rate in beat per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>At one hour after the beginning of the intervention</time_frame>
    <description>Blood pressure in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Experience of the surgical intervention</measure>
    <time_frame>At 24 hours after surgery</time_frame>
    <description>experience of the surgical intervention by the patient evaluated on a visual analog scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Experience of the surgical intervention</measure>
    <time_frame>one week after surgery</time_frame>
    <description>experience of the surgical intervention by the patient evaluated on a visual analog scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Experience of the perioperative period by the patient</measure>
    <time_frame>one week after surgery</time_frame>
    <description>Qualitative analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence adverse event</measure>
    <time_frame>Through study completion (Day 0 to Week 1)</time_frame>
    <description>Occurrence of hematoma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence adverse event</measure>
    <time_frame>Through study completion (Day 0 to Week 1)</time_frame>
    <description>Occurrence of infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence adverse event</measure>
    <time_frame>Through study completion (Day 0 to Week 1)</time_frame>
    <description>Occurrence of dysfunction of material</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-group comparison of the evolution of anxiety</measure>
    <time_frame>between the inclusion (Month -3) and the beginning of the intervention (Hour O)</time_frame>
    <description>Inter-group comparison of the evolution of anxiety by the STAI-YA</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Deep Brain Stimulation</condition>
  <arm_group>
    <arm_group_label>Patients without sessions of sophrology</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group is also composed of Parkinsonian patients waiting for deep brain surgery but will not have any special preparation for the procedure. They will be subjected to the same assessments at the same time as the sophrology group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with sessions of sophrology</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group is composed of patients with Parkinson's waiting for deep brain surgery. They will benefit from 10 sessions of sophrology in preparation for the intervention 5 weeks before this one.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>sessions of sophrology</intervention_name>
    <description>10 sessions of sophrology in preparation for the intervention 5 weeks before this one.</description>
    <arm_group_label>Patients with sessions of sophrology</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient (age greater than or equal to 18 years)&#xD;
&#xD;
          -  Patient with idiopathic Parkinson's disease with programmed deep brain stimulation&#xD;
             (VIM target, NST, single or bilateral GPI);&#xD;
&#xD;
          -  Planned intervention in an awake patient (implying MOCA&gt; 21 (Montreal Cognitive&#xD;
             Assessment));&#xD;
&#xD;
          -  Patient understanding the course of the study;&#xD;
&#xD;
          -  Patient who has given informed consent in writing;&#xD;
&#xD;
          -  Patient benefiting from a system of social insurance.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Intervention under general anesthesia;&#xD;
&#xD;
          -  Pregnant or nursing women;&#xD;
&#xD;
          -  Major person under protective measures (safeguard of justice, curatorship and&#xD;
             guardianship);&#xD;
&#xD;
          -  Person deprived of liberty.&#xD;
&#xD;
          -  Patient having already had a practice in yoga, sophrology, hypnotherapy superior or&#xD;
             equal to 5 sessions&#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_official>
    <last_name>Marc VERIN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rennes University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rennes University Hospital</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>February 17, 2023</last_update_submitted>
  <last_update_submitted_qc>February 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</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>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03273816
org study id: 35RC16_9805
nct id: NCT03273816
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Deep brain stimulation surgery, which consists of intracerebral implantation of electrodes,
      is considered one of the most effective techniques for controlling the motor fluctuations of
      Parkinson's disease. The particularity of this surgery is the necessity of the awakening of
      the patient for the correct positioning of the electrodes, it is therefore a difficult test
      for the patient.

      Medical sophrology is an ideal strategy to optimize the comfort of the patient during the
      operation thanks to its anxiolytic and analgesic virtues while guaranteeing the maintenance
      of a good patient vigilance favoring the cooperation with the operating room team. Indeed,
      sophrology is a body-mediated set of techniques, at the crossroads between hypnosis and yoga,
      which makes it possible to find a balance between emotions, thoughts and behaviors. It has
      already been applied in other fields such as oncology, pain management, preparation for
      childbirth, and for 5 years at the CHU of Rennes for preparation for the intervention of deep
      brain stimulation.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, controlled, bi-centric (national), superiority, open-label, blind-blind (evaluator) trial comparing sophrology to routine care in preparation for deep brain stimulation. The distribution of patients will be balanced between the two groups.
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: The primary endpoint is taken by a nurse who does not know the randomization arm.
measure: Patient anxiety
time frame: at one hour after the beginning of the intervention
description: patient anxiety evaluated by the STAI-YA (State Trait Anxiety Inventory), retranscribed by a caregiver of the block, the patient being unable in practice to fill in a questionnaire at that time
measure: Per operative pain
time frame: intraoperative (at the beginning of the intervention)
description: Per operative pain judged by a visual scale analogous
measure: Per operative pain
time frame: at one hour after the begginnig of the intervention
description: Per operative pain judged by a visual scale analogous
measure: Per operative pain
time frame: Intraoperative (At the end of the first electrode placement)
description: Per operative pain judged by a visual scale analogous
measure: Evaluation of the anxiety
time frame: At one hour before the procedure
description: Evaluation of the anxiety measured by the STAI YA
measure: Evaluation of the anxiety
time frame: Intraoperative (At the end of the first electrode placement)
description: Evaluation of the anxiety measured by the STAI YA
measure: Interaction between the patient and the surgical team during the procedure
time frame: At Day 0
description: interaction is judged by a visual analogue scale to be completed by the neurologist and the neurosurgeon
measure: The duration of the intervention in minutes
time frame: intraoperative
description: The duration of the intervention in minutes
measure: Heart rate
time frame: At one hour after the beginning of the intervention
description: Heart rate in beat per minute
measure: Blood pressure
time frame: At one hour after the beginning of the intervention
description: Blood pressure in mmHg
measure: Experience of the surgical intervention
time frame: At 24 hours after surgery
description: experience of the surgical intervention by the patient evaluated on a visual analog scale
measure: Experience of the surgical intervention
time frame: one week after surgery
description: experience of the surgical intervention by the patient evaluated on a visual analog scale
measure: Experience of the perioperative period by the patient
time frame: one week after surgery
description: Qualitative analysis
measure: Occurrence adverse event
time frame: Through study completion (Day 0 to Week 1)
description: Occurrence of hematoma
measure: Occurrence adverse event
time frame: Through study completion (Day 0 to Week 1)
description: Occurrence of infection
measure: Occurrence adverse event
time frame: Through study completion (Day 0 to Week 1)
description: Occurrence of dysfunction of material
measure: Inter-group comparison of the evolution of anxiety
time frame: between the inclusion (Month -3) and the beginning of the intervention (Hour O)
description: Inter-group comparison of the evolution of anxiety by the STAI-YA
arm group label: Patients without sessions of sophrology
arm group type: No Intervention
description: The control group is also composed of Parkinsonian patients waiting for deep brain surgery but will not have any special preparation for the procedure. They will be subjected to the same assessments at the same time as the sophrology group.
arm group label: Patients with sessions of sophrology
arm group type: Experimental
description: The experimental group is composed of patients with Parkinson's waiting for deep brain surgery. They will benefit from 10 sessions of sophrology in preparation for the intervention 5 weeks before this one.
intervention type: Behavioral
intervention name: sessions of sophrology
description: 10 sessions of sophrology in preparation for the intervention 5 weeks before this one.
arm group label: Patients with sessions of sophrology
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc VERIN
role: Principal Investigator
affiliation: Rennes University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: Undecided