<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/NCT03820700</url>
  </required_header>
  <id_info>
    <org_study_id>VRHICUliège</org_study_id>
    <nct_id>NCT03820700</nct_id>
  </id_info>
  <brief_title>Using Hypnosis and Virtual Reality During Pre and Postoperative Cardiovascular Surgery.</brief_title>
  <acronym>VRHypnICU</acronym>
  <official_title>The Influence of Non-pharmacological Medical Approaches Such as Hypnosis and Virtual Reality to Reduce Pain and Anxiety Before and After a Cardiovascular Surgery. A Randomized Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Liege</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Liege</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>
      Nowadays, the use of cognitive behavioral therapies has become quite common in the clinical&#xD;
      care. Different non-pharmacological techniques, including hypnosis and virtual reality are&#xD;
      currently used as complementary tools in the treatment of acute and chronic pain (Pourmand et&#xD;
      al., 2017; Vanhaudenhuyse et al., 2009). A new technique called 'virtual reality hypnosis'&#xD;
      (VRH) (Patterson et al., 2004), which encompasses a combination of both tools, is regularly&#xD;
      used although its actual function remains unknown to this date. With the goal to improve our&#xD;
      understanding of VRH combination effects, it is necessary to elaborate randomized and&#xD;
      controlled research studies in order to understand their actual function in individual's&#xD;
      perception.&#xD;
&#xD;
      100 patients who are undergoing a cardiovascular surgery at the Liège University Hospital&#xD;
      will be randomly assigned to four conditions (control, hypnosis, VR and VRH). Each&#xD;
      participant will receive two sessions of one of the techniques: one the day before the&#xD;
      surgery and one other session the day after, in intensive care units.&#xD;
&#xD;
      Physiological parameters will be taken and participants will fill in a questionnaire which&#xD;
      evaluates their level of perceived immersion, their level of anxiety, fatigue, pain and&#xD;
      relaxation. A short interview will also be conducted to give participants the opportunity to&#xD;
      openly describe their experience.&#xD;
&#xD;
      This study will help to expand the knowledge regarding the influence of these techniques on&#xD;
      patient's cognition, perception and sensation .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary outcome (anxiety) and secondary outcomes (pain, fatigue, relaxation and physiological&#xD;
      parameters) will be investigated at four measurement times: the day before the surgery (Day&#xD;
      -1) before the intervention (T0: baseline) and after the intervention (T1); the day after the&#xD;
      surgery (Day+1) before the intervention (T2) and after (T3).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 6, 2018</start_date>
  <completion_date type="Anticipated">December 28, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 28, 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)</time_frame>
    <description>Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No anxiety = 0, maximum anxiety = 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain perception</measure>
    <time_frame>Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)</time_frame>
    <description>Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No pain = 0, maximum pain = 10.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physiological parameters</measure>
    <time_frame>Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)</time_frame>
    <description>Arterial pressure, heartbeat, pupil size, oxygen saturation, respiratory rates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)</time_frame>
    <description>Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No fatigue = 0, maximum fatigue = 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relaxation</measure>
    <time_frame>Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)</time_frame>
    <description>Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No relaxation = 0, maximum relaxation = 10.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Participant's tendency to be absorbed and dissociated</measure>
    <time_frame>Day-1 before surgery (T0 before the intervention)</time_frame>
    <description>Dissociative Experience Scale (DES) 28-items (Beirnstein, 1986). This scale measures the dissociative experiences someone can experiment in everyday life.</description>
  </other_outcome>
  <other_outcome>
    <measure>Participant's opinion about the tool</measure>
    <time_frame>Day-1 before surgery (T1 after the intervention)</time_frame>
    <description>Satisfaction questionnaire created by our lab to understand if patients have a good adherence about the tool or not.</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of absorption at the moment</measure>
    <time_frame>Day-1 before surgery (T1 after intervention), Day+1 after surgery (T3 after the intervention)</time_frame>
    <description>Absorption will be measured as the two components of hypnosis. We will measure absorption and dissociation using the Visual Analogical Scales (VAS). VAS is from 0 to 10. 0 is not absorbed and 10 is really absorbed. When responding to a VAS item, participants will be asked to specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of dissociation at the moment</measure>
    <time_frame>Day-1 before surgery (T1 after intervention), Day+1 after surgery (T3 after the intervention)</time_frame>
    <description>Dissociation will be measured as the two components of hypnosis. We will measure absorption and dissociation using the Visual Analogical Scales (VAS). When responding to a VAS item, participants will be asked to specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.</description>
  </other_outcome>
  <other_outcome>
    <measure>Time perception</measure>
    <time_frame>Day-1 before surgery (T1 after intervention), Day+1 after surgery (T3 after the intervention)</time_frame>
    <description>We will ask to the patient his perception of time during the session.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Thoracic Surgery</condition>
  <condition>Pain, Postoperative</condition>
  <condition>Anxiety</condition>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>[Randomized] Patients in control group will receive regular nursing care but no behavioral therapy intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypnosis (Hypn)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>[Randomized] Patients will receive a hypnosis recorded audiotape.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Virtual reality (VR)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>[Randomized] Patients will see a 3D movie with a beautiful landscape.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Virtual reality hypnosis (VRH)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>[Randomized] Patients will see the same 3D film combined with a hypnotic voice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Hypnosis (Hypn)</intervention_name>
    <description>The hypnosis session will consist of a 20-minute hypnosis recording created by Marie-Elisabeth Faymonville and recorded by Anne-Sophie Nyssen, both professionals in hypnosis from University of Liège. The recording includes suggestions about relaxation, corporal sensations, respiratory techniques and visual imaginative stimuli about a beautiful landscape. With this tool, the hypnosis session is standardized for all patients and there is no need of a psychotherapist to deliver hypnosis.</description>
    <arm_group_label>Hypnosis (Hypn)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Virtual reality (VR)</intervention_name>
    <description>VR sessions. This session will consist in using a head-mounted 3D graphical display with goggles. With this tool, participants will be able to visualize a 3D immersive landscape for 20 minutes consisting of a shed near a lake at sunrise followed by a relaxing moment in the clouds. The session ends on the lake's edge.</description>
    <arm_group_label>Virtual reality (VR)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Virtual reality hypnosis (VRH)</intervention_name>
    <description>The combined tool sessions. Participants will be simultaneously subjected to the same hypnosis recording and 3D visual stimuli used in the Hypn and VR conditions.</description>
    <arm_group_label>Virtual reality hypnosis (VRH)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults undergoing cardiac surgery&#xD;
&#xD;
          -  Who have given consent for their participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychiatric antecedents&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Acrophobia,&#xD;
&#xD;
          -  Heavy hearing&#xD;
&#xD;
          -  Visual impairment&#xD;
&#xD;
          -  Infectious cases (example: conjunctivitis)&#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>Audrey Vanhaudenhuyse, PhD</last_name>
    <role>Study Director</role>
    <affiliation>CHU of Liège</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anne-Sophie Nyssen, Professor</last_name>
    <role>Study Director</role>
    <affiliation>University of Liege</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Floriane Rousseaux</last_name>
    <phone>003243663462</phone>
    <email>floriane.rousseaux@uliege.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Liège</name>
      <address>
        <city>Liège</city>
        <state>Province De Liège</state>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Floriane Rousseaux</last_name>
      <phone>003243663462</phone>
      <email>floriane.rousseaux@uliege.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 2, 2020</last_update_submitted>
  <last_update_submitted_qc>January 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Liege</investigator_affiliation>
    <investigator_full_name>Audrey Vanhaudenhuyse</investigator_full_name>
    <investigator_title>PhD, Responsible of the Sensation and Perception Research Group, in the GIGA CONSCIOUSNESS department</investigator_title>
  </responsible_party>
  <keyword>Virtual Reality</keyword>
  <keyword>Hypnosis</keyword>
  <keyword>Intensive care units</keyword>
  <keyword>Cardiac surgery</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Pain</keyword>
  <keyword>Cognition and perception</keyword>
  <keyword>Recovery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <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/NCT03820700
org study id: VRHICUliège
nct id: NCT03820700
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Nowadays, the use of cognitive behavioral therapies has become quite common in the clinical
      care. Different non-pharmacological techniques, including hypnosis and virtual reality are
      currently used as complementary tools in the treatment of acute and chronic pain (Pourmand et
      al., 2017; Vanhaudenhuyse et al., 2009). A new technique called 'virtual reality hypnosis'
      (VRH) (Patterson et al., 2004), which encompasses a combination of both tools, is regularly
      used although its actual function remains unknown to this date. With the goal to improve our
      understanding of VRH combination effects, it is necessary to elaborate randomized and
      controlled research studies in order to understand their actual function in individual's
      perception.

      100 patients who are undergoing a cardiovascular surgery at the Liège University Hospital
      will be randomly assigned to four conditions (control, hypnosis, VR and VRH). Each
      participant will receive two sessions of one of the techniques: one the day before the
      surgery and one other session the day after, in intensive care units.

      Physiological parameters will be taken and participants will fill in a questionnaire which
      evaluates their level of perceived immersion, their level of anxiety, fatigue, pain and
      relaxation. A short interview will also be conducted to give participants the opportunity to
      openly describe their experience.

      This study will help to expand the knowledge regarding the influence of these techniques on
      patient's cognition, perception and sensation .
Primary outcome (anxiety) and secondary outcomes (pain, fatigue, relaxation and physiological
      parameters) will be investigated at four measurement times: the day before the surgery (Day
      -1) before the intervention (T0: baseline) and after the intervention (T1); the day after the
      surgery (Day+1) before the intervention (T2) and after (T3).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Anxiety
time frame: Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)
description: Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No anxiety = 0, maximum anxiety = 10.
measure: Pain perception
time frame: Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)
description: Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No pain = 0, maximum pain = 10.
measure: Physiological parameters
time frame: Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)
description: Arterial pressure, heartbeat, pupil size, oxygen saturation, respiratory rates
measure: Fatigue
time frame: Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)
description: Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No fatigue = 0, maximum fatigue = 10.
measure: Relaxation
time frame: Day-1 before surgery (T0 before intervention; T1 after intervention), Day+1 after surgery (T2 before intervention; T3 after the intervention)
description: Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No relaxation = 0, maximum relaxation = 10.
measure: Participant's tendency to be absorbed and dissociated
time frame: Day-1 before surgery (T0 before the intervention)
description: Dissociative Experience Scale (DES) 28-items (Beirnstein, 1986). This scale measures the dissociative experiences someone can experiment in everyday life.
measure: Participant's opinion about the tool
time frame: Day-1 before surgery (T1 after the intervention)
description: Satisfaction questionnaire created by our lab to understand if patients have a good adherence about the tool or not.
measure: Level of absorption at the moment
time frame: Day-1 before surgery (T1 after intervention), Day+1 after surgery (T3 after the intervention)
description: Absorption will be measured as the two components of hypnosis. We will measure absorption and dissociation using the Visual Analogical Scales (VAS). VAS is from 0 to 10. 0 is not absorbed and 10 is really absorbed. When responding to a VAS item, participants will be asked to specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
measure: Level of dissociation at the moment
time frame: Day-1 before surgery (T1 after intervention), Day+1 after surgery (T3 after the intervention)
description: Dissociation will be measured as the two components of hypnosis. We will measure absorption and dissociation using the Visual Analogical Scales (VAS). When responding to a VAS item, participants will be asked to specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
measure: Time perception
time frame: Day-1 before surgery (T1 after intervention), Day+1 after surgery (T3 after the intervention)
description: We will ask to the patient his perception of time during the session.
arm group label: Control group
arm group type: No Intervention
description: [Randomized] Patients in control group will receive regular nursing care but no behavioral therapy intervention.
arm group label: Hypnosis (Hypn)
arm group type: Experimental
description: [Randomized] Patients will receive a hypnosis recorded audiotape.
arm group label: Virtual reality (VR)
arm group type: Experimental
description: [Randomized] Patients will see a 3D movie with a beautiful landscape.
arm group label: Virtual reality hypnosis (VRH)
arm group type: Experimental
description: [Randomized] Patients will see the same 3D film combined with a hypnotic voice.
intervention type: Behavioral
intervention name: Hypnosis (Hypn)
description: The hypnosis session will consist of a 20-minute hypnosis recording created by Marie-Elisabeth Faymonville and recorded by Anne-Sophie Nyssen, both professionals in hypnosis from University of Liège. The recording includes suggestions about relaxation, corporal sensations, respiratory techniques and visual imaginative stimuli about a beautiful landscape. With this tool, the hypnosis session is standardized for all patients and there is no need of a psychotherapist to deliver hypnosis.
arm group label: Hypnosis (Hypn)
intervention type: Behavioral
intervention name: Virtual reality (VR)
description: VR sessions. This session will consist in using a head-mounted 3D graphical display with goggles. With this tool, participants will be able to visualize a 3D immersive landscape for 20 minutes consisting of a shed near a lake at sunrise followed by a relaxing moment in the clouds. The session ends on the lake's edge.
arm group label: Virtual reality (VR)
intervention type: Behavioral
intervention name: Virtual reality hypnosis (VRH)
description: The combined tool sessions. Participants will be simultaneously subjected to the same hypnosis recording and 3D visual stimuli used in the Hypn and VR conditions.
arm group label: Virtual reality hypnosis (VRH)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Audrey Vanhaudenhuyse, PhD
role: Study Director
affiliation: CHU of Liège
last name: Anne-Sophie Nyssen, Professor
role: Study Director
affiliation: University of Liege
last name: Floriane Rousseaux
phone: 003243663462
email: floriane.rousseaux@uliege.be
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University of Liege
investigator full name: Audrey Vanhaudenhuyse
investigator title: PhD, Responsible of the Sensation and Perception Research Group, in the GIGA CONSCIOUSNESS department
mesh term: Pain, Postoperative
mesh term: Anxiety Disorders
sharing ipd: No