<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/NCT02987725</url>
  </required_header>
  <id_info>
    <org_study_id>F32sarahmartin2</org_study_id>
    <nct_id>NCT02987725</nct_id>
  </id_info>
  <brief_title>Laboratory-based Hypnosis Intervention on Pain Responsivity in Adolescents With Sickle Cell Disease</brief_title>
  <official_title>Laboratory-based Hypnosis Intervention on Pain Responsivity in Adolescents With Sickle Cell Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</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 purpose of this study is to test the effects of a laboratory-based hypnosis session&#xD;
      compared to an attention control condition on peripheral blood flow, autonomic stress&#xD;
      responses, and acute pain responses in adolescents (ages 12-21) with sickle cell disease, and&#xD;
      examine how perceived disease-related stigma may affect these responses.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 16, 2018</start_date>
  <completion_date type="Actual">November 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in peripheral blood flow before and during the intervention</measure>
    <time_frame>Beginning 15 minutes prior to the intervention (hypnosis or attention control) and continuing during 30 minutes of the intervention</time_frame>
    <description>Peripheral blood flow will be measured using continuous readings of oxygen saturation, pulse rate, and pulse waveform from the thumb and change in blood flow will be assessed by comparing levels of blood flow during the pre-intervention period (15 minutes prior to intervention to a minute before the start of intervention) from blood flow during the intervention period (from the start of the intervention until 30 minutes after the start of the intervention).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in pain threshold temperature</measure>
    <time_frame>12 minutes before the start of the intervention and 15 minutes after the start of the intervention.</time_frame>
    <description>Pain threshold temperature will be determined by when participants report they first feel pain and change in pain threshold temperature will be assessed by comparing pain threshold temperature during the pre-intervention period (12 minutes before the start of the intervention) from pain threshold temperature during the intervention period (15 minutes after the start of the intervention).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain tolerance temperature</measure>
    <time_frame>9 minutes before the start of the intervention and 18 minutes after the start of the intervention.</time_frame>
    <description>Pain tolerance temperature will be determined by when participants report they can no longer tolerate the pain and change in pain tolerance temperature will be assessed by comparing pain tolerance temperature during the pre-intervention period (9 minutes before the start of the intervention) from pain tolerance temperature during the intervention period (18 minutes after the start of the intervention).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in heat pulse pain intensity ratings</measure>
    <time_frame>5 minutes before the start of the intervention and 21 minutes after the start of the intervention.</time_frame>
    <description>Heat pulse pain intensity ratings will be determined by participants' self-report of heat pulse pain intensity (rated on a 0-10 scale, with 0 being no pain and 10 being worst pain), and change in heat pulse pain intensity will be assessed by comparing pain tolerance temperature during the pre-intervention period (5 minutes before the start of the intervention) from heat pulse pain intensity during the intervention period (21 minutes after the start of the intervention).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the effect of the intervention on peripheral blood flow at different levels of disease-related stigma</measure>
    <time_frame>15 minutes prior to the start of the intervention to a minute before the start of the intervention and from the start of the intervention to 30 minutes after the start of the intervention</time_frame>
    <description>Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing levels of blood flow during the pre-intervention period (15 minutes prior to intervention to a minute before the start of intervention) from blood flow during the intervention period (from the start of the intervention until 30 minutes after the start of the intervention).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the effect of the intervention on pain threshold temperature at different levels of disease-related stigma</measure>
    <time_frame>12 minutes before the start of the intervention and 15 minutes after the start of the intervention</time_frame>
    <description>Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing pain threshold collected 12 minutes before the start of the intervention and 15 minutes after the start of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the effect of the intervention on pain tolerance temperature at different levels of disease-related stigma</measure>
    <time_frame>9 minutes before the start of the intervention and 18 minutes after the start of the intervention.</time_frame>
    <description>Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing pain tolerance collected 9 minutes before the start of the intervention and 18 minutes after the start of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the effect of the intervention on heat pulse pain intensity ratings at different levels of disease-related stigma</measure>
    <time_frame>5 minutes before the start of the intervention and 21 minutes after the start of the intervention.</time_frame>
    <description>Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing pain intensity collected 5 minutes before the start of the intervention and 21 minutes after the start of the intervention.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in the effect of the intervention on Skin Conductance Response (SCR)</measure>
    <time_frame>12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention</time_frame>
    <description>Skin Conductance Response (SCR) will be measured using continuous readings of electrical properties of the skin on the index finger and change in SCR will be assessed by comparing levels of SCR during the pre-intervention period (12-5 minutes prior to intervention to the start of intervention) from SCR during the intervention period (15-21 minutes after the start of the intervention).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in the effect of the intervention on Heart Rate Variability</measure>
    <time_frame>12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention</time_frame>
    <description>Heart Rate Variability (HRV) will be measured using continuous readings of heartbeat intervals and change in HRV will be assessed by comparing HRV during the pre-intervention period (12-5 minutes prior to intervention to the start of intervention) from HRV during the intervention period (15-21 minutes after the start of the intervention).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Sickle Cell Disease</condition>
  <arm_group>
    <arm_group_label>Attention Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will listen to a 30-minute historical story.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypnosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a 30-minute hypnosis session</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Hypnosis</intervention_name>
    <description>A 30-minute Hypnosis session with a trained clinician focused on relaxation and hypnotic suggestions for pain relief and reduced stress responses.</description>
    <arm_group_label>Hypnosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Attention Control</intervention_name>
    <description>A 30-minute historical story read by a research clinician.</description>
    <arm_group_label>Attention Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of sickle cell disease&#xD;
&#xD;
          -  Age 12-21 years old&#xD;
&#xD;
          -  Fluent in English (the intervention will be delivered in English)&#xD;
&#xD;
          -  Participant is cognitively able to provide informed signed consent or assent&#xD;
&#xD;
          -  Participant is cognitively able to follow instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 12 years of age or over 21 years of age&#xD;
&#xD;
          -  Not fluent in English&#xD;
&#xD;
          -  Pain medication prescription has changed or if they have been hospitalized for a&#xD;
             vaso-occlusive episode within 30 days of study participation.&#xD;
&#xD;
          -  Diagnosis of a condition (e.g., neurological disorder affecting peripheral sensation,&#xD;
             skin abnormality over the stimulus site, obstructive sleep apnea, diabetes, ischemic&#xD;
             heart disease) or cognitive impairment that may affect data integrity or the ability&#xD;
             to complete study procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lonnie K Zeltzer, MD</last_name>
    <role>Study Chair</role>
    <affiliation>UCLA Pediatric Pain and Palliative Care Program</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Sarah R. Martin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Adolescence</keyword>
  <keyword>Autonomic Nervous System</keyword>
  <keyword>Hypnosis</keyword>
  <keyword>Pain</keyword>
  <keyword>Sickle Cell Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Sickle Cell</mesh_term>
  </condition_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/NCT02987725
org study id: F32sarahmartin2
nct id: NCT02987725
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test the effects of a laboratory-based hypnosis session
      compared to an attention control condition on peripheral blood flow, autonomic stress
      responses, and acute pain responses in adolescents (ages 12-21) with sickle cell disease, and
      examine how perceived disease-related stigma may affect these responses.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in peripheral blood flow before and during the intervention
time frame: Beginning 15 minutes prior to the intervention (hypnosis or attention control) and continuing during 30 minutes of the intervention
description: Peripheral blood flow will be measured using continuous readings of oxygen saturation, pulse rate, and pulse waveform from the thumb and change in blood flow will be assessed by comparing levels of blood flow during the pre-intervention period (15 minutes prior to intervention to a minute before the start of intervention) from blood flow during the intervention period (from the start of the intervention until 30 minutes after the start of the intervention).
measure: Change in pain threshold temperature
time frame: 12 minutes before the start of the intervention and 15 minutes after the start of the intervention.
description: Pain threshold temperature will be determined by when participants report they first feel pain and change in pain threshold temperature will be assessed by comparing pain threshold temperature during the pre-intervention period (12 minutes before the start of the intervention) from pain threshold temperature during the intervention period (15 minutes after the start of the intervention).
measure: Change in pain tolerance temperature
time frame: 9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
description: Pain tolerance temperature will be determined by when participants report they can no longer tolerate the pain and change in pain tolerance temperature will be assessed by comparing pain tolerance temperature during the pre-intervention period (9 minutes before the start of the intervention) from pain tolerance temperature during the intervention period (18 minutes after the start of the intervention).
measure: Change in heat pulse pain intensity ratings
time frame: 5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
description: Heat pulse pain intensity ratings will be determined by participants' self-report of heat pulse pain intensity (rated on a 0-10 scale, with 0 being no pain and 10 being worst pain), and change in heat pulse pain intensity will be assessed by comparing pain tolerance temperature during the pre-intervention period (5 minutes before the start of the intervention) from heat pulse pain intensity during the intervention period (21 minutes after the start of the intervention).
measure: Change in the effect of the intervention on peripheral blood flow at different levels of disease-related stigma
time frame: 15 minutes prior to the start of the intervention to a minute before the start of the intervention and from the start of the intervention to 30 minutes after the start of the intervention
description: Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing levels of blood flow during the pre-intervention period (15 minutes prior to intervention to a minute before the start of intervention) from blood flow during the intervention period (from the start of the intervention until 30 minutes after the start of the intervention).
measure: Change in the effect of the intervention on pain threshold temperature at different levels of disease-related stigma
time frame: 12 minutes before the start of the intervention and 15 minutes after the start of the intervention
description: Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing pain threshold collected 12 minutes before the start of the intervention and 15 minutes after the start of the intervention.
measure: Change in the effect of the intervention on pain tolerance temperature at different levels of disease-related stigma
time frame: 9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
description: Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing pain tolerance collected 9 minutes before the start of the intervention and 18 minutes after the start of the intervention.
measure: Change in the effect of the intervention on heat pulse pain intensity ratings at different levels of disease-related stigma
time frame: 5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
description: Stigma will be assessed via a questionnaire completed prior to the start of the laboratory session and will be compared to the change in effect, which is assessed by comparing pain intensity collected 5 minutes before the start of the intervention and 21 minutes after the start of the intervention.
measure: Change in the effect of the intervention on Skin Conductance Response (SCR)
time frame: 12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention
description: Skin Conductance Response (SCR) will be measured using continuous readings of electrical properties of the skin on the index finger and change in SCR will be assessed by comparing levels of SCR during the pre-intervention period (12-5 minutes prior to intervention to the start of intervention) from SCR during the intervention period (15-21 minutes after the start of the intervention).
measure: Change in the effect of the intervention on Heart Rate Variability
time frame: 12-5 minutes prior to the start of the intervention and 15-21 minutes after the start of the intervention
description: Heart Rate Variability (HRV) will be measured using continuous readings of heartbeat intervals and change in HRV will be assessed by comparing HRV during the pre-intervention period (12-5 minutes prior to intervention to the start of intervention) from HRV during the intervention period (15-21 minutes after the start of the intervention).
arm group label: Attention Control
arm group type: Active Comparator
description: Participants will listen to a 30-minute historical story.
arm group label: Hypnosis
arm group type: Experimental
description: Participants will receive a 30-minute hypnosis session
intervention type: Behavioral
intervention name: Hypnosis
description: A 30-minute Hypnosis session with a trained clinician focused on relaxation and hypnotic suggestions for pain relief and reduced stress responses.
arm group label: Hypnosis
intervention type: Behavioral
intervention name: Attention Control
description: A 30-minute historical story read by a research clinician.
arm group label: Attention Control
criteria: 
gender: All
minimum age: 12 Years
maximum age: 21 Years
healthy volunteers: No
last name: Lonnie K Zeltzer, MD
role: Study Chair
affiliation: UCLA Pediatric Pain and Palliative Care Program
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Sarah R. Martin
investigator title: Principal Investigator
mesh term: Anemia, Sickle Cell