<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/NCT04473014</url>
  </required_header>
  <id_info>
    <org_study_id>Heat Pain</org_study_id>
    <nct_id>NCT04473014</nct_id>
  </id_info>
  <brief_title>The Role of Sensory Processing Sensitivity in Pediatric Chronic Pain</brief_title>
  <official_title>Towards a Deeper Understanding of Chronic Pediatric Pain: Exploring the Role of Sensory Processing Sensitivity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this project is to increase scientific understanding of whether the trait of SPS&#xD;
      can help explain increased pain sensitivity and hence vulnerability for chronic pain.&#xD;
      Additionally, it will be tested whether participants with high SPS report differences in pain&#xD;
      intensity in response to positive, negative, or neutral mood induction compared to&#xD;
      individuals with lower SPS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Pain is defined as an unpleasant sensory and emotional experience and in its&#xD;
      chronic form, pain is highly prevalent, up to 25% of children and adolescents are affected by&#xD;
      it. The exact etiology of many forms of chronic pain remains unknown. One mechanism that has&#xD;
      been proposed to underlie increased pain sensitivity is central sensitization, i.e.,&#xD;
      increased efficacy of the nervous system in transmitting pain signals, which manifests itself&#xD;
      as a lower pain threshold. A lower pain threshold in turn has been recognized as a risk&#xD;
      factor for the development of chronic pain. Being more sensitive to pain is one feature&#xD;
      commonly shared by those with high sensory processing sensitivity (SPS), who are thought to&#xD;
      react more strongly to both positive and negative environmental influences. The relationship&#xD;
      between this increased sensitivity and pain tolerance has not been studied to date, but could&#xD;
      contribute to our understanding of why some children and adolescents are more vulnerable to&#xD;
      developing chronic pain than others.&#xD;
&#xD;
      Objectives and Aims: The aim of this project is to increase scientific understanding of&#xD;
      whether the trait of SPS can help explain increased pain sensitivity and hence vulnerability&#xD;
      for chronic pain. Additionally, it will be tested whether participants with high SPS report&#xD;
      differences in pain intensity in response to positive, negative, or neutral mood induction&#xD;
      compared to individuals with lower SPS.&#xD;
&#xD;
      Methods: To examine differences in pain perception of an experimentally induced pain stimulus&#xD;
      between people with varying levels of SPS and whether pain perception can modulated by&#xD;
      positive, negative, or neutral mood induction, I will apply a heat pain paradigm in a sample&#xD;
      of healthy adolescents. Participants will be randomized to either neutral, positive or&#xD;
      negative mood induction and I will test whether their pain sensitivity differs as a function&#xD;
      of their scores on a high sensitivity scale and with regard to mood induction.&#xD;
&#xD;
      Expected Results: We expect highly sensitive adolescents to have a lower pain threshold and&#xD;
      tolerance and to react more strongly to positive (with decreased pain ratings) and negative&#xD;
      (with increased pain ratings) mood induction compared to those with lower scores on the&#xD;
      sensitivity scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 21, 2021</start_date>
  <completion_date type="Actual">May 15, 2022</completion_date>
  <primary_completion_date type="Actual">April 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Threshold</measure>
    <time_frame>1 day</time_frame>
    <description>Temperature point where participants feel it changing from &quot;hot&quot; to &quot;painful&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Tolerance</measure>
    <time_frame>1 day</time_frame>
    <description>the time in seconds elapsed from the onset of the pain stimulus to a participant's withdrawal from the stimulus</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Positive Mood</arm_group_label>
    <description>This group will be exposed to a positive mood induction prior to heat pain.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Negative Mood</arm_group_label>
    <description>This group will be exposed to a negative mood induction prior to heat pain.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neutral Mood</arm_group_label>
    <description>This group will be exposed to a neutral mood induction prior to heat pain.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Heat Pain Paradigm</intervention_name>
    <description>A standardized heat pain paradigm will be applied. Pain threshold will be determined with the self-controlled search method starting at 32°C, with a mouse-click-induced increase of 0.1°C per click. Pain tolerance is defined as the time in seconds elapsed from the onset of the pain stimulus to a participant's withdrawal from the stimulus. Participants will be instructed to continue with the task for as long as they can and to press a button if it becomes too uncomfortable or painful. Temperature will then return to baseline. To avoid physical injury, the measurement will stop automatically at a maximum temperature of 50°C.</description>
    <arm_group_label>Negative Mood</arm_group_label>
    <arm_group_label>Neutral Mood</arm_group_label>
    <arm_group_label>Positive Mood</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be recruited from local schools and at the University of Basel,&#xD;
        Switzerland.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adolescents aged 16-19 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic pain or another chronic condition&#xD;
&#xD;
          -  Skin pathologies&#xD;
&#xD;
          -  Sensory abnormalities affecting the tactile or thermal modality&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Current medication&#xD;
&#xD;
          -  Current psychological or psychiatric treatment&#xD;
&#xD;
          -  Insufficient language skills to understand the instructions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helen Koechlin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Basel, Switzerland; Boston Children's Hospital, Boston, MA, USA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Psychology, University of Basel</name>
      <address>
        <city>Basel</city>
        <zip>40555</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Basel, Switzerland</investigator_affiliation>
    <investigator_full_name>Helen Koechlin</investigator_full_name>
    <investigator_title>Adjunct Senior Researcher</investigator_title>
  </responsible_party>
  <keyword>sensory processing sensitivity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <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>


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/NCT04473014
org study id: Heat Pain
nct id: NCT04473014
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this project is to increase scientific understanding of whether the trait of SPS
      can help explain increased pain sensitivity and hence vulnerability for chronic pain.
      Additionally, it will be tested whether participants with high SPS report differences in pain
      intensity in response to positive, negative, or neutral mood induction compared to
      individuals with lower SPS.
Background: Pain is defined as an unpleasant sensory and emotional experience and in its
      chronic form, pain is highly prevalent, up to 25% of children and adolescents are affected by
      it. The exact etiology of many forms of chronic pain remains unknown. One mechanism that has
      been proposed to underlie increased pain sensitivity is central sensitization, i.e.,
      increased efficacy of the nervous system in transmitting pain signals, which manifests itself
      as a lower pain threshold. A lower pain threshold in turn has been recognized as a risk
      factor for the development of chronic pain. Being more sensitive to pain is one feature
      commonly shared by those with high sensory processing sensitivity (SPS), who are thought to
      react more strongly to both positive and negative environmental influences. The relationship
      between this increased sensitivity and pain tolerance has not been studied to date, but could
      contribute to our understanding of why some children and adolescents are more vulnerable to
      developing chronic pain than others.

      Objectives and Aims: The aim of this project is to increase scientific understanding of
      whether the trait of SPS can help explain increased pain sensitivity and hence vulnerability
      for chronic pain. Additionally, it will be tested whether participants with high SPS report
      differences in pain intensity in response to positive, negative, or neutral mood induction
      compared to individuals with lower SPS.

      Methods: To examine differences in pain perception of an experimentally induced pain stimulus
      between people with varying levels of SPS and whether pain perception can modulated by
      positive, negative, or neutral mood induction, I will apply a heat pain paradigm in a sample
      of healthy adolescents. Participants will be randomized to either neutral, positive or
      negative mood induction and I will test whether their pain sensitivity differs as a function
      of their scores on a high sensitivity scale and with regard to mood induction.

      Expected Results: We expect highly sensitive adolescents to have a lower pain threshold and
      tolerance and to react more strongly to positive (with decreased pain ratings) and negative
      (with increased pain ratings) mood induction compared to those with lower scores on the
      sensitivity scale.
observational model: Other
time perspective: Other
measure: Pain Threshold
time frame: 1 day
description: Temperature point where participants feel it changing from "hot" to "painful"
measure: Pain Tolerance
time frame: 1 day
description: the time in seconds elapsed from the onset of the pain stimulus to a participant's withdrawal from the stimulus
arm group label: Positive Mood
description: This group will be exposed to a positive mood induction prior to heat pain.
arm group label: Negative Mood
description: This group will be exposed to a negative mood induction prior to heat pain.
arm group label: Neutral Mood
description: This group will be exposed to a neutral mood induction prior to heat pain.
intervention type: Behavioral
intervention name: Heat Pain Paradigm
description: A standardized heat pain paradigm will be applied. Pain threshold will be determined with the self-controlled search method starting at 32°C, with a mouse-click-induced increase of 0.1°C per click. Pain tolerance is defined as the time in seconds elapsed from the onset of the pain stimulus to a participant's withdrawal from the stimulus. Participants will be instructed to continue with the task for as long as they can and to press a button if it becomes too uncomfortable or painful. Temperature will then return to baseline. To avoid physical injury, the measurement will stop automatically at a maximum temperature of 50°C.
arm group label: Negative Mood
arm group label: Neutral Mood
arm group label: Positive Mood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Helen Koechlin, PhD
role: Principal Investigator
affiliation: University of Basel, Switzerland; Boston Children's Hospital, Boston, MA, USA
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Basel, Switzerland
investigator full name: Helen Koechlin
investigator title: Adjunct Senior Researcher
mesh term: Hypersensitivity
mesh term: Chronic Pain
sharing ipd: Undecided