<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/NCT03030482</url>
  </required_header>
  <id_info>
    <org_study_id>P14/10_REaLAX</org_study_id>
    <nct_id>NCT03030482</nct_id>
  </id_info>
  <brief_title>Evaluation of Touch Massage on Anxiety in Critically Ill Patients</brief_title>
  <acronym>REaLAX</acronym>
  <official_title>Evaluation of Touch Massage on Anxiety in Critically Ill Patients : a Randomised Controlled Trial Study (REaLAX)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Versailles Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Versailles 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>
      Anxiety is a common problem encountered in a about 43 % of critically ill patients. Its&#xD;
      occurrence can be related to several causes, mainly dominated by invasive procedures.&#xD;
&#xD;
      anxiety management is typically based on a combination of prevention, evaluation, and&#xD;
      therapeutic agents. However, it appears important to develop adjuvant approaches. Touch&#xD;
      massage is one of them and that has been evaluated in various medical conditions.&#xD;
&#xD;
      The aim of our study is to evaluate the anxiolytic effect of touch massage in critically ill&#xD;
      patients during potentially painful nursing procedures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 20, 2017</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure the anxiolytic value of touch massage to critically ill patient, awake, communicating</measure>
    <time_frame>60 minutes</time_frame>
    <description>Total score variation of the Spielberger STAI Y-A anxiety scale (short form) before and after the touch massage session (score 6-24) or standard care ICU.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure the correlation between the Spielberger STAI Y-A (short form) anxiety scale and the Anxiety Visual Anxiety Scale (EVA-A).</measure>
    <time_frame>60 minutes</time_frame>
    <description>Patient anxiety will be evaluated by the score of anxiety measured in millimeters from 0 to 100 using a Visual analogue scale of anxiety (EVA - A) before and after touch massage session or standard care ICU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure the analgesic effect of touch massage to critically ill patient awake, communicating</measure>
    <time_frame>60 minutes</time_frame>
    <description>Pain will be evaluated by the pain score measured in millimeters of 0 and 100 with scale visual analog pain (EVA) before and touch massage session or standard care ICU.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Touch massage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will have a touch massage session during 30 minutes the intervention will take place remotely (1 h) of all events that can generate anxiety</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>standard care ICU</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>touch massage</intervention_name>
    <description>Patients will have a touch massage session during 30 minutes the intervention will take place remotely (1 h) of all events that can generate anxiety</description>
    <arm_group_label>Touch massage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients (age≥18 years) hospitalized in Intensive Care Unit &gt; 24 h&#xD;
&#xD;
          -  Requiring mechanical ventilation or not&#xD;
&#xD;
          -  Securité Sociale affiliated&#xD;
&#xD;
          -  Patient with accessible zone for touch massage (head-face, arms-hands, feet, legs and&#xD;
             back)&#xD;
&#xD;
          -  No significant event (invasive procedure, diagnostic ad, CAT,MRI) before enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Legal guardianship&#xD;
&#xD;
          -  Neurological failure : stroke ischemic or hemorrhagic, meningitis, status&#xD;
             epilepticus,polytrauma( including head trauma),meningo encephalitis, meningism,&#xD;
&#xD;
          -  Patient with upper limbs neuromuscular disorders&#xD;
&#xD;
          -  Cutaneous lesion (zone of touch massage)&#xD;
&#xD;
          -  Temperature ≥ 38,5°C&#xD;
&#xD;
          -  A positive score of CAM ICU scale&#xD;
&#xD;
          -  Patient refuse to participate&#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>Versailles Hospital</name>
      <address>
        <city>Le Chesnay</city>
        <state>Yvelines</state>
        <zip>78150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 21, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>February 11, 2021</last_update_submitted>
  <last_update_submitted_qc>February 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Versailles Hospital</investigator_affiliation>
    <investigator_full_name>Melot Karine</investigator_full_name>
    <investigator_title>Study principal investigator</investigator_title>
  </responsible_party>
  <keyword>Anxiety</keyword>
  <keyword>intensive care</keyword>
  <keyword>mechanical ventilation</keyword>
  <keyword>touch massage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <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/NCT03030482
org study id: P14/10_REaLAX
nct id: NCT03030482
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Anxiety is a common problem encountered in a about 43 % of critically ill patients. Its
      occurrence can be related to several causes, mainly dominated by invasive procedures.

      anxiety management is typically based on a combination of prevention, evaluation, and
      therapeutic agents. However, it appears important to develop adjuvant approaches. Touch
      massage is one of them and that has been evaluated in various medical conditions.

      The aim of our study is to evaluate the anxiolytic effect of touch massage in critically ill
      patients during potentially painful nursing procedures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Measure the anxiolytic value of touch massage to critically ill patient, awake, communicating
time frame: 60 minutes
description: Total score variation of the Spielberger STAI Y-A anxiety scale (short form) before and after the touch massage session (score 6-24) or standard care ICU.
measure: Measure the correlation between the Spielberger STAI Y-A (short form) anxiety scale and the Anxiety Visual Anxiety Scale (EVA-A).
time frame: 60 minutes
description: Patient anxiety will be evaluated by the score of anxiety measured in millimeters from 0 to 100 using a Visual analogue scale of anxiety (EVA - A) before and after touch massage session or standard care ICU.
measure: Measure the analgesic effect of touch massage to critically ill patient awake, communicating
time frame: 60 minutes
description: Pain will be evaluated by the pain score measured in millimeters of 0 and 100 with scale visual analog pain (EVA) before and touch massage session or standard care ICU.
arm group label: Touch massage
arm group type: Experimental
description: Patients will have a touch massage session during 30 minutes the intervention will take place remotely (1 h) of all events that can generate anxiety
arm group label: control
arm group type: No Intervention
description: standard care ICU
intervention type: Procedure
intervention name: touch massage
description: Patients will have a touch massage session during 30 minutes the intervention will take place remotely (1 h) of all events that can generate anxiety
arm group label: Touch massage
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Versailles Hospital
investigator full name: Melot Karine
investigator title: Study principal investigator
mesh term: Anxiety Disorders
sharing ipd: No