<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/NCT02261155</url>
  </required_header>
  <id_info>
    <org_study_id>LMU 137/06</org_study_id>
    <nct_id>NCT02261155</nct_id>
  </id_info>
  <brief_title>Changes in Sensory Perception During Hypnotic Relaxation</brief_title>
  <official_title>Veränderungen Der Sensibilität Durch Medizinische Hypnose</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ludwig-Maximilians - University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ludwig-Maximilians - University of Munich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Changes in sensory thresholds and pain thresholds will be measured with quantitative sensory&#xD;
      testing (QST) before and during hypnotic relaxation in healthy volunteers. Hypnotic&#xD;
      susceptibility will be assessed before QST.&#xD;
&#xD;
      QST data before and during hypnosis will be compared. Observed sensory changes will be&#xD;
      evaluated in relation to the assessed hypnotic susceptibility&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Healthy volunteers will be recruited and tested regarding their hypnotic susceptibility with&#xD;
      Harvard Group Scale. In a second session QST will be performed on the right hand.Then&#xD;
      hypnosis will be induced with the fixation method. After that the hypnotherapist will ask&#xD;
      them to focus their attention on imagining an individual situation of well-being and calmness&#xD;
      the volunteers had described before hypnosis. Then QST will be performed a second time on the&#xD;
      same location. Results be compared using student's ttest.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2006</start_date>
  <completion_date type="Actual">August 2007</completion_date>
  <primary_completion_date type="Actual">August 2007</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Quantitative Sensory Testing</measure>
    <time_frame>1 hour</time_frame>
    <description>Quantitative Sensory Testing, in detail the following thresholds are included in the testing: Thermal thresholds Cold detection threshold, CDT (°C from baseline 32°C) Warm detection threshold, WDT (°C from baseline 32°C) Thermal sensory limen, TSL (°C) Paradox heat sensation, PHS (x/3) Cold pain threshold, CPT (°C) Heat pain threshold, HPT (°C) Mechanical detection threshold, MDT (mN) Mechanical pain threshold, MPT (mN) Mechanical pain sensitivity, (MPS) Dynamic mechanical allodynia, (DMA) Wind-up, (WUR) Vibration detection threshold, (VDT) (x/8) Pressure pain threshold, (PPT; Pa)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Observed sensory changes during hypnosis compared to hypnotic susceptibility</measure>
    <time_frame>1 hour</time_frame>
    <description>The correlation between the obeserved changes as described above and the degree of hypnotic susceptibility</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Hypnosis</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>hypnotic induction followed by relaxation and pleasant imagery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hypnosis</intervention_name>
    <description>hypnotic Relaxation without specific analgesic suggestion</description>
    <arm_group_label>Hypnosis</arm_group_label>
    <other_name>hypnotic relaxation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  health conditions of any Kind&#xD;
&#xD;
          -  inability to read and/ or sign informed consent&#xD;
&#xD;
          -  previous hypnosis experience&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dominik Irnich, Pd Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Multidisciplinary Pain Centre, Department of Anesthesiology, University of Munich</affiliation>
  </overall_official>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>October 6, 2014</last_update_submitted>
  <last_update_submitted_qc>October 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ludwig-Maximilians - University of Munich</investigator_affiliation>
    <investigator_full_name>Dominik Irnich</investigator_full_name>
    <investigator_title>PD Dr. med.; Head of the Multidisciplinary Pain Centre</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypnotics and Sedatives</mesh_term>
  </intervention_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/NCT02261155
org study id: LMU 137/06
nct id: NCT02261155
lead sponsor: 
has dmc: No
Changes in sensory thresholds and pain thresholds will be measured with quantitative sensory
      testing (QST) before and during hypnotic relaxation in healthy volunteers. Hypnotic
      susceptibility will be assessed before QST.

      QST data before and during hypnosis will be compared. Observed sensory changes will be
      evaluated in relation to the assessed hypnotic susceptibility
Healthy volunteers will be recruited and tested regarding their hypnotic susceptibility with
      Harvard Group Scale. In a second session QST will be performed on the right hand.Then
      hypnosis will be induced with the fixation method. After that the hypnotherapist will ask
      them to focus their attention on imagining an individual situation of well-being and calmness
      the volunteers had described before hypnosis. Then QST will be performed a second time on the
      same location. Results be compared using student's ttest.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Changes in Quantitative Sensory Testing
time frame: 1 hour
description: Quantitative Sensory Testing, in detail the following thresholds are included in the testing: Thermal thresholds Cold detection threshold, CDT (°C from baseline 32°C) Warm detection threshold, WDT (°C from baseline 32°C) Thermal sensory limen, TSL (°C) Paradox heat sensation, PHS (x/3) Cold pain threshold, CPT (°C) Heat pain threshold, HPT (°C) Mechanical detection threshold, MDT (mN) Mechanical pain threshold, MPT (mN) Mechanical pain sensitivity, (MPS) Dynamic mechanical allodynia, (DMA) Wind-up, (WUR) Vibration detection threshold, (VDT) (x/8) Pressure pain threshold, (PPT; Pa)
measure: Observed sensory changes during hypnosis compared to hypnotic susceptibility
time frame: 1 hour
description: The correlation between the obeserved changes as described above and the degree of hypnotic susceptibility
arm group label: Hypnosis
arm group type: Other
description: hypnotic induction followed by relaxation and pleasant imagery
intervention type: Procedure
intervention name: Hypnosis
description: hypnotic Relaxation without specific analgesic suggestion
arm group label: Hypnosis
other name: hypnotic relaxation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dominik Irnich, Pd Dr. med.
role: Principal Investigator
affiliation: Multidisciplinary Pain Centre, Department of Anesthesiology, University of Munich
responsible party type: Principal Investigator
investigator affiliation: Ludwig-Maximilians - University of Munich
investigator full name: Dominik Irnich
investigator title: PD Dr. med.; Head of the Multidisciplinary Pain Centre
mesh term: Hypnotics and Sedatives