xml: <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/NCT06038370</url>
    </required_header>
    <id_info>
      <org_study_id>2015-85</org_study_id>
      <nct_id>NCT06038370</nct_id>
    </id_info>
    <brief_title>Self-induced Cognitive Trance for Chronic Pain Management</brief_title>
    <official_title>Self-induced Cognitive Trance to Improve Quality of Life of Patients With Chronic</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>
        The need to find complementary approaches, based on a holistic perspective of the human&#xD;
        being, takes on its full meaning in a political context that recommends efficient health&#xD;
        programs. Self-induced cognitive trance is one of these complementary approaches, which&#xD;
        induce a non-ordinary state of consciousness. The aim of this work is to evaluate whether&#xD;
        learning self-induced cognitive trance can improve the quality of life of people with chronic&#xD;
        pain. Participants will participate in two times two days workshop aiming at learning how to&#xD;
        self-induce cognitive trance. Pain, Fatigue, anxiety, depression, attitudes towards pain, and&#xD;
        quality of life will be assessed before and after each workshops. Two follow-ups at 6 and 12&#xD;
        months afer the last workshop will be caried out were outomes will be assessed. Furthmore,&#xD;
        questionnaires related to the phenomenology of self-induced cognitive trance will be&#xD;
        adeministrered. Investigators also proceeded to interveiwes after the second workshop to&#xD;
        gather qualitative information.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 15, 2023</start_date>
    <completion_date type="Anticipated">January 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">February 10, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain intensity</measure>
      <time_frame>Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up</time_frame>
      <description>Visual Analog Scale will be used to assess pain, at the present moment, at its weakest and strongest, on a scale of 0 (no pain) to 10 (worst pain imaginable)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fatigue intensity</measure>
      <time_frame>Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up</time_frame>
      <description>Visual Analog Scale will be used to assess pain, at the present moment, at its weakest and strongest, on a scale of 0 (no pain) to 10 (worst pain imaginable)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Anxiety</measure>
      <time_frame>Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up</time_frame>
      <description>Hospital Anxiety and Depression scale comprises 14 items subdivided into 7 sub-items, each linked to a subscale, one for the level of anxiety and one for the level of depression, for a total score ranging from 0 to 21 for each of these subscales. A score of 0 to 7 is equivalent to a &quot;normal&quot; state, a score of 8 to 10 suggests only the presence of a mood disorder, a score of 11 to 15 indicates the probable presence of a moderate mood disorder, and finally, a score above 16 indicates a severe mood disorder.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Depression</measure>
      <time_frame>Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up</time_frame>
      <description>Hospital Anxiety and Depression scale comprises 14 items subdivided into 7 sub-items, each linked to a subscale, one for the level of anxiety and one for the level of depression, for a total score ranging from 0 to 21 for each of these subscales. A score of 0 to 7 is equivalent to a &quot;normal&quot; state, a score of 8 to 10 suggests only the presence of a mood disorder, a score of 11 to 15 indicates the probable presence of a moderate mood disorder, and finally, a score above 16 indicates a severe mood disorder.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Attitudes towards pain</measure>
      <time_frame>Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up</time_frame>
      <description>The Survey of Pain Attitude-35. It is composed of 7 subscales: perceived disability measures the belief that disability is caused by pain; pain-injury link assesses the belief that pain is a physical injury; medication measures the belief that medication is the only remedy, solicitude measures the belief that those around patients should assist them in their painful experience, expectation of cure measures the belief that doctors are responsible for reducing their pain, perceived control assesses the feeling of perceived control, and finally, emotion measures the feeling that emotions have an impact on pain. Scores are specific to each scale. The higher the score, the more patients hold this belief.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of life</measure>
      <time_frame>Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up</time_frame>
      <description>The Short From Health Survey assesses overall quality of life. It comprises 36 items subdivided into 9 subscales: physical functioning, limitations resulting from physical health, limitations resulting from emotional health, vitality (energy/fatigue), emotional well-being, social functioning, pain, general state of health and, finally, changes in state of health. Each of these scales is weighted by a score ranging from 0 to 100. The first 8 dimensions of the SF-36 are grouped into 2 synthetic scores. A physical score (PCS) groups the 8 dimensions according to a weighting that favors the physical component, while the mental score (MCS) summarizes the mental component of the dimension scores. The higher the scores, the better the mental and physical health. The final item assesses perceived change in health status.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Global Impression of change</measure>
      <time_frame>Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up</time_frame>
      <description>Global Impression of change assesses patients' beliefs about the effectiveness of their treatment on their disease. It's a simple scale that goes up to 7 points, equivalent to the best possible improvement.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Positive affect</measure>
      <time_frame>Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up</time_frame>
      <description>The Positive Affect and Negative Affect Schedule is dedicated to measuring mood and feelings. The questionnaire comprises two scales. The first measures positive affect, the second negative affect. Each scale comprises 10 items, for a total of 20 items, and each item is rated on a scale from 1 (very little or not at all) to 5 (very much or not at all).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Negative affect</measure>
      <time_frame>Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up</time_frame>
      <description>The Positive Affect and Negative Affect Schedule is dedicated to measuring mood and feelings. The questionnaire comprises two scales. The first measures positive affect, the second negative affect. Each scale comprises 10 items, for a total of 20 items, and each item is rated on a scale from 1 (very little or not at all) to 5 (very much or not at all).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ego-Dissolution</measure>
      <time_frame>Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up</time_frame>
      <description>Ego-Dissolution Inventory comprises 16 items subdivided into 2 subscales representing ego inflation and ego dissolution, each scale comprising 8 items. Each item is monitored by a numerical score ranging from 0 (no, no more than usual) to 100 (yes, entirely or completely).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mystical Experience</measure>
      <time_frame>Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up</time_frame>
      <description>Mystical Experiences Questionnaire comprises 30 items divided into 4 subscales representing mysticism, which qualifies experiences of communication with a reality that cannot be discerned by common sense, positive mood, transcendence of time and space, and ineffability, which represents the experience of being able to communicate with a reality that cannot be discerned by common sense. considers that the experience cannot be described in words, each item is evaluated with a score ranging from 0 (none, not at all) to 5 (extreme, more than any other moment in my life and more than 4).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phenomenology of trance</measure>
      <time_frame>Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up</time_frame>
      <description>Assessed through a self-made questionnaire. It consists of 10 questions, each of which is evaluated by a score ranging from 1 (strongly disagree) to 7 (strongly agree).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Experience with trance</measure>
      <time_frame>Immediately after the second workshop</time_frame>
      <description>Semi-structured interview</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">6</enrollment>
    <condition>Chronic Pain</condition>
    <arm_group>
      <arm_group_label>Self-induced cognitive trance</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Self-induced cognitive trance</intervention_name>
      <description>The cognitive trance-based intervention will consist of a two-day workshop in groups of approximately 10 participants, where they will learn how to induce the cognitive trance, with the use of different sound-loops that can induce trance in untrained people in a safe way. After two weeks of home practice, participants will redo a two-day consolidation training. At-home practice is encouraged between sessions.</description>
      <arm_group_label>Self-induced cognitive trance</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  French speacking&#xD;
  &#xD;
            -  Chronic pain&#xD;
  &#xD;
            -  On stable pharmacological treatment over the last four months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Psychiatric disorders,&#xD;
  &#xD;
            -  drug addiction&#xD;
  &#xD;
            -  alcoholism&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Aminata Aminata, PhD</last_name>
      <email>abicego@uliege.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Vanhaudenhuyse Audrey, PhD</last_name>
      <phone>003243238033</phone>
      <email>avanhaudenhuyse@chuliege.be</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CHU of Liège</name>
        <address>
          <city>Liège</city>
          <zip>4000</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Aminata Bicego, PhD</last_name>
        <phone>003243663499</phone>
        <email>abicego@uliege.be</email>
      </contact>
      <contact_backup>
        <last_name>Audrey Vanhaudenhuyse, PI</last_name>
        <phone>003243668033</phone>
        <email>avanhaudenhuyse@chuliege.be</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>University of Liège</name>
        <address>
          <city>Liège</city>
          <zip>4000</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Audrey Vanhaudenhuyse, PhD</last_name>
        <phone>+3243668482</phone>
        <email>avanhaudenhuyse@chuliege.be</email>
      </contact>
      <contact_backup>
        <last_name>Aminata Bicego, PhD</last_name>
        <phone>+3243663499</phone>
        <email>abicego@uliege.be</email>
      </contact_backup>
      <investigator>
        <last_name>Olivia Gosseries, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</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>Head</investigator_title>
    </responsible_party>
    <keyword>Self-induced cognitive trance</keyword>
    <keyword>Non-ordinary state of consciousness</keyword>
    <keyword>Pain</keyword>
    <keyword>Quality of life</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Chronic Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06038370
  org study id: 2015-85
  nct id: NCT06038370
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The need to find complementary approaches, based on a holistic perspective of the human
        being, takes on its full meaning in a political context that recommends efficient health
        programs. Self-induced cognitive trance is one of these complementary approaches, which
        induce a non-ordinary state of consciousness. The aim of this work is to evaluate whether
        learning self-induced cognitive trance can improve the quality of life of people with chronic
        pain. Participants will participate in two times two days workshop aiming at learning how to
        self-induce cognitive trance. Pain, Fatigue, anxiety, depression, attitudes towards pain, and
        quality of life will be assessed before and after each workshops. Two follow-ups at 6 and 12
        months afer the last workshop will be caried out were outomes will be assessed. Furthmore,
        questionnaires related to the phenomenology of self-induced cognitive trance will be
        adeministrered. Investigators also proceeded to interveiwes after the second workshop to
        gather qualitative information.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Pain intensity
  time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
  description: Visual Analog Scale will be used to assess pain, at the present moment, at its weakest and strongest, on a scale of 0 (no pain) to 10 (worst pain imaginable)
  measure: Fatigue intensity
  time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
  description: Visual Analog Scale will be used to assess pain, at the present moment, at its weakest and strongest, on a scale of 0 (no pain) to 10 (worst pain imaginable)
  measure: Anxiety
  time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
  description: Hospital Anxiety and Depression scale comprises 14 items subdivided into 7 sub-items, each linked to a subscale, one for the level of anxiety and one for the level of depression, for a total score ranging from 0 to 21 for each of these subscales. A score of 0 to 7 is equivalent to a "normal" state, a score of 8 to 10 suggests only the presence of a mood disorder, a score of 11 to 15 indicates the probable presence of a moderate mood disorder, and finally, a score above 16 indicates a severe mood disorder.
  measure: Depression
  time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
  description: Hospital Anxiety and Depression scale comprises 14 items subdivided into 7 sub-items, each linked to a subscale, one for the level of anxiety and one for the level of depression, for a total score ranging from 0 to 21 for each of these subscales. A score of 0 to 7 is equivalent to a "normal" state, a score of 8 to 10 suggests only the presence of a mood disorder, a score of 11 to 15 indicates the probable presence of a moderate mood disorder, and finally, a score above 16 indicates a severe mood disorder.
  measure: Attitudes towards pain
  time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
  description: The Survey of Pain Attitude-35. It is composed of 7 subscales: perceived disability measures the belief that disability is caused by pain; pain-injury link assesses the belief that pain is a physical injury; medication measures the belief that medication is the only remedy, solicitude measures the belief that those around patients should assist them in their painful experience, expectation of cure measures the belief that doctors are responsible for reducing their pain, perceived control assesses the feeling of perceived control, and finally, emotion measures the feeling that emotions have an impact on pain. Scores are specific to each scale. The higher the score, the more patients hold this belief.
  measure: Quality of life
  time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
  description: The Short From Health Survey assesses overall quality of life. It comprises 36 items subdivided into 9 subscales: physical functioning, limitations resulting from physical health, limitations resulting from emotional health, vitality (energy/fatigue), emotional well-being, social functioning, pain, general state of health and, finally, changes in state of health. Each of these scales is weighted by a score ranging from 0 to 100. The first 8 dimensions of the SF-36 are grouped into 2 synthetic scores. A physical score (PCS) groups the 8 dimensions according to a weighting that favors the physical component, while the mental score (MCS) summarizes the mental component of the dimension scores. The higher the scores, the better the mental and physical health. The final item assesses perceived change in health status.
  measure: Global Impression of change
  time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
  description: Global Impression of change assesses patients' beliefs about the effectiveness of their treatment on their disease. It's a simple scale that goes up to 7 points, equivalent to the best possible improvement.
  measure: Positive affect
  time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
  description: The Positive Affect and Negative Affect Schedule is dedicated to measuring mood and feelings. The questionnaire comprises two scales. The first measures positive affect, the second negative affect. Each scale comprises 10 items, for a total of 20 items, and each item is rated on a scale from 1 (very little or not at all) to 5 (very much or not at all).
  measure: Negative affect
  time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
  description: The Positive Affect and Negative Affect Schedule is dedicated to measuring mood and feelings. The questionnaire comprises two scales. The first measures positive affect, the second negative affect. Each scale comprises 10 items, for a total of 20 items, and each item is rated on a scale from 1 (very little or not at all) to 5 (very much or not at all).
  measure: Ego-Dissolution
  time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
  description: Ego-Dissolution Inventory comprises 16 items subdivided into 2 subscales representing ego inflation and ego dissolution, each scale comprising 8 items. Each item is monitored by a numerical score ranging from 0 (no, no more than usual) to 100 (yes, entirely or completely).
  measure: Mystical Experience
  time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
  description: Mystical Experiences Questionnaire comprises 30 items divided into 4 subscales representing mysticism, which qualifies experiences of communication with a reality that cannot be discerned by common sense, positive mood, transcendence of time and space, and ineffability, which represents the experience of being able to communicate with a reality that cannot be discerned by common sense. considers that the experience cannot be described in words, each item is evaluated with a score ranging from 0 (none, not at all) to 5 (extreme, more than any other moment in my life and more than 4).
  measure: Phenomenology of trance
  time frame: Assessed before the intervention, immediately after the first workshop, immediately after the second workshop and at 6- and 12-month follow-up
  description: Assessed through a self-made questionnaire. It consists of 10 questions, each of which is evaluated by a score ranging from 1 (strongly disagree) to 7 (strongly agree).
  measure: Experience with trance
  time frame: Immediately after the second workshop
  description: Semi-structured interview
  arm group label: Self-induced cognitive trance
  arm group type: Experimental
  intervention type: Behavioral
  intervention name: Self-induced cognitive trance
  description: The cognitive trance-based intervention will consist of a two-day workshop in groups of approximately 10 participants, where they will learn how to induce the cognitive trance, with the use of different sound-loops that can induce trance in untrained people in a safe way. After two weeks of home practice, participants will redo a two-day consolidation training. At-home practice is encouraged between sessions.
  arm group label: Self-induced cognitive trance
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Aminata Aminata, PhD
  email: abicego@uliege.be
  last name: Vanhaudenhuyse Audrey, PhD
  phone: 003243238033
  email: avanhaudenhuyse@chuliege.be
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Belgium
  responsible party type: Principal Investigator
  investigator affiliation: University of Liege
  investigator full name: Audrey Vanhaudenhuyse
  investigator title: Head
  mesh term: Chronic Pain
  sharing ipd: Undecided