<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/NCT03809195</url>
  </required_header>
  <id_info>
    <org_study_id>181436</org_study_id>
    <nct_id>NCT03809195</nct_id>
  </id_info>
  <brief_title>Clinical Hypnosis in Pediatric Crohn's Disease</brief_title>
  <acronym>HypnoCrohns</acronym>
  <official_title>Clinical Hypnosis in Pediatric Crohn's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</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>
      Inflammatory bowel disease (IBD), which includes Crohn's disease (CD) and ulcerative colitis&#xD;
      (UC), is a chronic, immune-mediated disease increasingly prevalent in youth. Patients with&#xD;
      IBD experience pain, fatigue, altered bowel habits, psychological distress, and reduced&#xD;
      quality of life. Regardless of disease activity, persistent pain and psychiatric&#xD;
      comorbidities both have a negative impact on quality of life. Alongside standard&#xD;
      pharmacologic and nutritional therapies, clinical hypnosis is a complementary therapy that&#xD;
      may improve physical and psychosocial outcomes in these patients. Clinical hypnosis consists&#xD;
      of guiding the patient into a relaxed and focused state and providing therapeutic suggestions&#xD;
      to induce desired physiologic and psychologic change. Children and adolescents are excellent&#xD;
      candidates for hypnosis by virtue of their vivid imaginations. Hypnosis is effective in&#xD;
      management of functional abdominal pain, irritable bowel syndrome, anxiety, chronic pain, and&#xD;
      distress related to medical procedures. To date, there are no clinical trials that evaluate&#xD;
      the effects of hypnosis in pediatric patients with IBD, but there is strong conceptual&#xD;
      support for its role in improving pain and psychological distress in these patients. In&#xD;
      addition to genetic, environmental, and microbial influences, a growing body of evidence&#xD;
      supports the role of a dysregulated brain-gut axis and chronic stress in IBD. Animal and&#xD;
      human studies demonstrate the effect of stress on the immune system and gastrointestinal&#xD;
      tract. Studies show that the benefits of hypnosis may extend to its role in increasing vagal&#xD;
      tone and regulating the immune system via the brain-gut axis. Adults with UC receiving a&#xD;
      hypnosis intervention demonstrated improved remission and decreased inflammatory markers.&#xD;
      Case series suggest that children with inflammatory bowel disease benefit from hypnosis, and&#xD;
      it can be safely and easily delivered via audio recordings. Patients with IBD are interested&#xD;
      in integrative therapies to reduce symptoms and improve quality of life, and a&#xD;
      biopsychosocial approach is essential in their care. The addition of hypnosis may improve&#xD;
      outcomes through influence on stress, inflammation, coping, symptom perception, and quality&#xD;
      of life.&#xD;
&#xD;
      The investigators hypothesize that pediatric patients with CD participating in a clinical&#xD;
      hypnosis intervention as an adjunct to standard of care will report improved quality of life&#xD;
      compared to a waitlist control group. The specific aims of the study are as follows: (1) To&#xD;
      implement hypnosis as an adjunctive therapy in adolescents with CD. (2) To evaluate the&#xD;
      impact of hypnosis in CD on measures of quality of life. (3) To evaluate the impact of&#xD;
      hypnosis in CD on pain, depression, anxiety, sleep, and coping.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2019</start_date>
  <completion_date type="Actual">May 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</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>
    <intervention_model_description>intervention group versus control group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IMPACT-III</measure>
    <time_frame>Change from baseline to 8 weeks.</time_frame>
    <description>Pediatric inflammatory bowel disease-specific health-related quality of life measure. &quot;IMPACT&quot; is not an abbreviation, but rather the name of the scale. Minimum score 0 to maximum score 100, with higher signifying better quality of life. Subjects get a total score (0 to 100) and a score for each of six subscales (0 to 100): Bowel Symptoms (7 items), Treatment/Interventions (3 items), Social Functioning (12 items), Emotional Functioning (7 items), Body Image (3 items), Systemic Symptoms (3 items). Each of the 35 total items has five multiple choice options and is given a score of 0, 25, 50, 75, or 100 points. The subscale scores are an average of the scores for each item that corresponds to that subscale. The total score is an average of all item scores.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Cantril Ladder</measure>
    <time_frame>Change from baseline to 8 weeks.</time_frame>
    <description>Single item quality of life measure. From 0 to 10, with 10 representing the best quality of life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PedsQL 4.0 Generic Core Scale, Parent Proxy</measure>
    <time_frame>Change from baseline to 8 weeks.</time_frame>
    <description>&quot;PedsQL&quot; refers to Pediatric Quality of Life. This is a pediatric 23-item measure of health-related quality of life. Questions fall under one of five domains: Physical Functioning (8 items), Emotional Functioning (5), Social Functioning (5 items), School Functioning (5 items). Yields a total score and two summary scores-Physical Health (comprised of physical functioning domain) and Psychosocial Health (comprised of each item in the 5-item emotional, social, and school functioning domains). Each item is rated on a 5-point Likert scale. Total score and the two summary scores are linearly transformed into a 0 to 100 point scale, with higher scores representing better quality of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PROMIS Pediatric Anxiety, short form</measure>
    <time_frame>Change from baseline to 8 weeks.</time_frame>
    <description>PROMIS stands for Patient-Reported Outcomes Measurement Information System. This measure is 8 items each scored from 1 to 5 points, with the lowest possible raw score being 8 and the highest possible raw score being 40. Higher scores indicate greater anxiety, i.e. worse. The raw score is translated into a T-score. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Pediatric Depressive Symptoms, short form</measure>
    <time_frame>Change from baseline to 8 weeks.</time_frame>
    <description>PROMIS stands for Patient-Reported Outcomes Measurement Information System. This measure is 8 items each scored from 1 to 5 points, with the lowest possible raw score being 8 and the highest possible raw score being 40. Higher scores indicate greater depressive symptoms, i.e. worse. The raw score is translated into a T-score. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Pediatric Sleep Disturbance, short form</measure>
    <time_frame>Change from baseline to 8 weeks.</time_frame>
    <description>PROMIS stands for Patient-Reported Outcomes Measurement Information System. This measure is 8 items each scored from 1 to 5 points, with the lowest possible raw score being 8 and the highest possible raw score being 40. Higher scores indicate greater sleep disturbance, i.e. worse sleep. The raw score is translated into a T-score. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Beliefs Questionnaire, short form</measure>
    <time_frame>Change from baseline to 8 weeks.</time_frame>
    <description>This is an 18-item measure designed assess youth's beliefs about their abdominal pain. It is comprised of three subscales each with 6 items-Pain Threat, Problem-Focused Coping Efficacy (PFCE), and Emotion-Focused Coping Efficacy (EFCE). The respondent rates each item on how true the statement is for them on a 5-point scale ranging from 0 (&quot;not at all true&quot;) to 4 (&quot;very true&quot;). Subscale scores are computed by averaging the items pertaining to each subscale. For Pain Threat, higher score indicates stronger beliefs that one's pain represents a personal threat. For the PFCE and EFCE subscales, higher scores indicate a stronger belief in one's ability to cope with pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abdominal Pain Intensity</measure>
    <time_frame>Change from baseline to 8 weeks.</time_frame>
    <description>Two items combined for a total score, range from 0 to 20, with higher scores representing greater pain intensity. Each item rated on a scale from 0 (no pain) to 10 (most possible pain). The first item assesses the respondent's worst pain in the past week, and the second item assesses the usual intensity of the pain experienced during the past week. Adapted from the Abdominal Pain Index, with permission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare utilization</measure>
    <time_frame>Change from baseline to 8 weeks.</time_frame>
    <description>By parent report, total number of contacts health care provider for their child in the past 8 weeks, other than previously scheduled check-ups, including emergency department visits, urgent care visits, and phone calls or messages to the doctor's office</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>School absences</measure>
    <time_frame>Change from baseline to 8 weeks.</time_frame>
    <description>By parent report, number of days of school the child has missed in the past 8 weeks (choices: 0, 1-3, 4-6, 7-10, more than 10 days). If on school break, parent asked to estimate as if school was in session--for example, how many days the child had to miss usual activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abdominal Pain Frequency</measure>
    <time_frame>Change from baseline to 8 weeks.</time_frame>
    <description>How many days did the respondent experience pain in the past week, with options being never, 1-2 days, 3-4 days, 5-6 days, or daily, with greater frequency of pain being worse. Adapted from the Abdominal Pain Index, with permission.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>IMPACT-III</measure>
    <time_frame>Change from baseline to secondary time point at 16 weeks.</time_frame>
    <description>Pediatric inflammatory bowel disease-specific health-related quality of life measure. &quot;IMPACT&quot; is not an abbreviation, but rather the name of the scale. Minimum score 0 to maximum score 100, with higher signifying better quality of life. Subjects get a total score (0 to 100) and a score for each of six subscales (0 to 100): Bowel Symptoms (7 items), Treatment/Interventions (3 items), Social Functioning (12 items), Emotional Functioning (7 items), Body Image (3 items), Systemic Symptoms (3 items). Each of the 35 total items has five multiple choice options and is given a score of 0, 25, 50, 75, or 100 points. The subscale scores are an average of the scores for each item that corresponds to that subscale. The total score is an average of all item scores.</description>
  </other_outcome>
  <other_outcome>
    <measure>PedsQL 4.0 Generic Core Scale, Parent Proxy</measure>
    <time_frame>Change from baseline to secondary time point at 16 weeks.</time_frame>
    <description>&quot;PedsQL&quot; refers to Pediatric Quality of Life. This is a pediatric 23-item measure of health-related quality of life. Questions fall under one of five domains: Physical Functioning (8 items), Emotional Functioning (5), Social Functioning (5 items), School Functioning (5 items). Yields a total score and two summary scores-Physical Health (comprised of physical functioning domain) and Psychosocial Health (comprised of each item in the 5-item emotional, social, and school functioning domains). Each item is rated on a 5-point Likert scale. Total score and the two summary scores are linearly transformed into a 0 to 100 point scale, with higher scores representing better quality of life.</description>
  </other_outcome>
  <other_outcome>
    <measure>Modified Cantril Ladder</measure>
    <time_frame>change over time monitored weekly for 8 weeks then at secondary time point at 16 weeks</time_frame>
    <description>Single item quality of life measure. From 0 to 10, with 10 representing the best quality of life.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Pediatric Crohns Disease</condition>
  <arm_group>
    <arm_group_label>Hypnosis Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention is clinical hypnosis--a single in-person session followed by instructions to listen to audio recordings at home. The sessions consist of the provider's voice guiding the participant into a relaxed and focused state and providing therapeutic suggestions--for example, to replace discomfort with a more pleasant sensation, to ease anxiety, and to increase energy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will serve as a control comparison and be offered the intervention after control data collection is complete.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Clinical Hypnosis</intervention_name>
    <description>See information in arm/group description. Four different audio recordings are provided electronically, each approximately 20 minutes in length. Participants are encouraged to listen to one daily.</description>
    <arm_group_label>Hypnosis Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with Crohn's disease at least 3 months prior to enrollment&#xD;
&#xD;
          -  Inactive, mild, or moderate disease activity by Improve Care Now Physician's Global&#xD;
             Assessment (ICN PGA) at most recent GI clinic visit&#xD;
&#xD;
          -  Ages 12-18 years at time of enrollment&#xD;
&#xD;
          -  English-speaking and with the normal cognitive development required to understand the&#xD;
             verbal instructions/suggestions provided in the hypnosis session/audio recordings and&#xD;
             to understand and complete the written surveys&#xD;
&#xD;
          -  Has daily access to an electronic device (ex. smartphone, computer) that can receive&#xD;
             text messages or e-mail, on which online surveys can be completed, and on which the&#xD;
             participant can access and listen to audio recordings.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with Crohn's disease less than 3 months prior to enrollment&#xD;
&#xD;
          -  Severe disease activity per ICN PGA at most recent GI clinic visit&#xD;
&#xD;
          -  Age &lt; 12 years or &gt; 18 years&#xD;
&#xD;
          -  Non-English speaking or having a cognitive disability that precludes understanding the&#xD;
             verbal instructions/suggestions provided in the hypnosis session/audio recordings and&#xD;
             the completion of written surveys&#xD;
&#xD;
          -  Lacks daily access to an electronic device (ex. smartphone, computer) that can receive&#xD;
             text messages or e-mail, on which online surveys can be completed, and on which the&#xD;
             participant can access and listen to audio recordings.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amanda D Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Stone AL, Walker LS, Laird KT, Shirkey KC, Smith CA. Pediatric Pain Beliefs Questionnaire: Psychometric Properties of the Short Form. J Pain. 2016 Sep;17(9):1036-44. doi: 10.1016/j.jpain.2016.06.006. Epub 2016 Jun 27.</citation>
    <PMID>27363626</PMID>
  </reference>
  <reference>
    <citation>Forrest CB, Meltzer LJ, Marcus CL, de la Motte A, Kratchman A, Buysse DJ, Pilkonis PA, Becker BD, Bevans KB. Development and validation of the PROMIS Pediatric Sleep Disturbance and Sleep-Related Impairment item banks. Sleep. 2018 Jun 1;41(6). doi: 10.1093/sleep/zsy054.</citation>
    <PMID>29546286</PMID>
  </reference>
  <reference>
    <citation>Zhang YZ, Li YY. Inflammatory bowel disease: pathogenesis. World J Gastroenterol. 2014 Jan 7;20(1):91-9. doi: 10.3748/wjg.v20.i1.91.</citation>
    <PMID>24415861</PMID>
  </reference>
  <reference>
    <citation>Mackner LM, Greenley RN, Szigethy E, Herzer M, Deer K, Hommel KA. Psychosocial issues in pediatric inflammatory bowel disease: report of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2013 Apr;56(4):449-58. doi: 10.1097/MPG.0b013e3182841263.</citation>
    <PMID>23287808</PMID>
  </reference>
  <reference>
    <citation>Kunz JH, Hommel KA, Greenley RN. Health-related quality of life of youth with inflammatory bowel disease: a comparison with published data using the PedsQL 4.0 generic core scales. Inflamm Bowel Dis. 2010 Jun;16(6):939-46. doi: 10.1002/ibd.21128.</citation>
    <PMID>19998462</PMID>
  </reference>
  <reference>
    <citation>Vlieger AM, Menko-Frankenhuis C, Wolfkamp SC, Tromp E, Benninga MA. Hypnotherapy for children with functional abdominal pain or irritable bowel syndrome: a randomized controlled trial. Gastroenterology. 2007 Nov;133(5):1430-6. doi: 10.1053/j.gastro.2007.08.072. Epub 2007 Sep 2.</citation>
    <PMID>17919634</PMID>
  </reference>
  <reference>
    <citation>Palsson OS. Hypnosis Treatment of Gastrointestinal Disorders: A Comprehensive Review of the Empirical Evidence. Am J Clin Hypn. 2015 Oct;58(2):134-58. doi: 10.1080/00029157.2015.1039114.</citation>
    <PMID>26264539</PMID>
  </reference>
  <reference>
    <citation>Bonaz BL, Bernstein CN. Brain-gut interactions in inflammatory bowel disease. Gastroenterology. 2013 Jan;144(1):36-49. doi: 10.1053/j.gastro.2012.10.003. Epub 2012 Oct 12.</citation>
    <PMID>23063970</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Amanda Lee</investigator_full_name>
    <investigator_title>Clinical Fellow</investigator_title>
  </responsible_party>
  <keyword>hypnosis</keyword>
  <keyword>inflammatory bowel disease</keyword>
  <keyword>mind-body</keyword>
  <keyword>brain-gut</keyword>
  <keyword>hypnotherapy</keyword>
  <keyword>quality of life</keyword>
  <keyword>psychosocial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</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/NCT03809195
org study id: 181436
nct id: NCT03809195
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Inflammatory bowel disease (IBD), which includes Crohn's disease (CD) and ulcerative colitis
      (UC), is a chronic, immune-mediated disease increasingly prevalent in youth. Patients with
      IBD experience pain, fatigue, altered bowel habits, psychological distress, and reduced
      quality of life. Regardless of disease activity, persistent pain and psychiatric
      comorbidities both have a negative impact on quality of life. Alongside standard
      pharmacologic and nutritional therapies, clinical hypnosis is a complementary therapy that
      may improve physical and psychosocial outcomes in these patients. Clinical hypnosis consists
      of guiding the patient into a relaxed and focused state and providing therapeutic suggestions
      to induce desired physiologic and psychologic change. Children and adolescents are excellent
      candidates for hypnosis by virtue of their vivid imaginations. Hypnosis is effective in
      management of functional abdominal pain, irritable bowel syndrome, anxiety, chronic pain, and
      distress related to medical procedures. To date, there are no clinical trials that evaluate
      the effects of hypnosis in pediatric patients with IBD, but there is strong conceptual
      support for its role in improving pain and psychological distress in these patients. In
      addition to genetic, environmental, and microbial influences, a growing body of evidence
      supports the role of a dysregulated brain-gut axis and chronic stress in IBD. Animal and
      human studies demonstrate the effect of stress on the immune system and gastrointestinal
      tract. Studies show that the benefits of hypnosis may extend to its role in increasing vagal
      tone and regulating the immune system via the brain-gut axis. Adults with UC receiving a
      hypnosis intervention demonstrated improved remission and decreased inflammatory markers.
      Case series suggest that children with inflammatory bowel disease benefit from hypnosis, and
      it can be safely and easily delivered via audio recordings. Patients with IBD are interested
      in integrative therapies to reduce symptoms and improve quality of life, and a
      biopsychosocial approach is essential in their care. The addition of hypnosis may improve
      outcomes through influence on stress, inflammation, coping, symptom perception, and quality
      of life.

      The investigators hypothesize that pediatric patients with CD participating in a clinical
      hypnosis intervention as an adjunct to standard of care will report improved quality of life
      compared to a waitlist control group. The specific aims of the study are as follows: (1) To
      implement hypnosis as an adjunctive therapy in adolescents with CD. (2) To evaluate the
      impact of hypnosis in CD on measures of quality of life. (3) To evaluate the impact of
      hypnosis in CD on pain, depression, anxiety, sleep, and coping.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: intervention group versus control group
primary purpose: Treatment
masking: None (Open Label)
measure: IMPACT-III
time frame: Change from baseline to 8 weeks.
description: Pediatric inflammatory bowel disease-specific health-related quality of life measure. "IMPACT" is not an abbreviation, but rather the name of the scale. Minimum score 0 to maximum score 100, with higher signifying better quality of life. Subjects get a total score (0 to 100) and a score for each of six subscales (0 to 100): Bowel Symptoms (7 items), Treatment/Interventions (3 items), Social Functioning (12 items), Emotional Functioning (7 items), Body Image (3 items), Systemic Symptoms (3 items). Each of the 35 total items has five multiple choice options and is given a score of 0, 25, 50, 75, or 100 points. The subscale scores are an average of the scores for each item that corresponds to that subscale. The total score is an average of all item scores.
measure: Modified Cantril Ladder
time frame: Change from baseline to 8 weeks.
description: Single item quality of life measure. From 0 to 10, with 10 representing the best quality of life.
measure: PedsQL 4.0 Generic Core Scale, Parent Proxy
time frame: Change from baseline to 8 weeks.
description: "PedsQL" refers to Pediatric Quality of Life. This is a pediatric 23-item measure of health-related quality of life. Questions fall under one of five domains: Physical Functioning (8 items), Emotional Functioning (5), Social Functioning (5 items), School Functioning (5 items). Yields a total score and two summary scores-Physical Health (comprised of physical functioning domain) and Psychosocial Health (comprised of each item in the 5-item emotional, social, and school functioning domains). Each item is rated on a 5-point Likert scale. Total score and the two summary scores are linearly transformed into a 0 to 100 point scale, with higher scores representing better quality of life.
measure: PROMIS Pediatric Anxiety, short form
time frame: Change from baseline to 8 weeks.
description: PROMIS stands for Patient-Reported Outcomes Measurement Information System. This measure is 8 items each scored from 1 to 5 points, with the lowest possible raw score being 8 and the highest possible raw score being 40. Higher scores indicate greater anxiety, i.e. worse. The raw score is translated into a T-score. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.
measure: PROMIS Pediatric Depressive Symptoms, short form
time frame: Change from baseline to 8 weeks.
description: PROMIS stands for Patient-Reported Outcomes Measurement Information System. This measure is 8 items each scored from 1 to 5 points, with the lowest possible raw score being 8 and the highest possible raw score being 40. Higher scores indicate greater depressive symptoms, i.e. worse. The raw score is translated into a T-score. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.
measure: PROMIS Pediatric Sleep Disturbance, short form
time frame: Change from baseline to 8 weeks.
description: PROMIS stands for Patient-Reported Outcomes Measurement Information System. This measure is 8 items each scored from 1 to 5 points, with the lowest possible raw score being 8 and the highest possible raw score being 40. Higher scores indicate greater sleep disturbance, i.e. worse sleep. The raw score is translated into a T-score. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.
measure: Pain Beliefs Questionnaire, short form
time frame: Change from baseline to 8 weeks.
description: This is an 18-item measure designed assess youth's beliefs about their abdominal pain. It is comprised of three subscales each with 6 items-Pain Threat, Problem-Focused Coping Efficacy (PFCE), and Emotion-Focused Coping Efficacy (EFCE). The respondent rates each item on how true the statement is for them on a 5-point scale ranging from 0 ("not at all true") to 4 ("very true"). Subscale scores are computed by averaging the items pertaining to each subscale. For Pain Threat, higher score indicates stronger beliefs that one's pain represents a personal threat. For the PFCE and EFCE subscales, higher scores indicate a stronger belief in one's ability to cope with pain.
measure: Abdominal Pain Intensity
time frame: Change from baseline to 8 weeks.
description: Two items combined for a total score, range from 0 to 20, with higher scores representing greater pain intensity. Each item rated on a scale from 0 (no pain) to 10 (most possible pain). The first item assesses the respondent's worst pain in the past week, and the second item assesses the usual intensity of the pain experienced during the past week. Adapted from the Abdominal Pain Index, with permission.
measure: Healthcare utilization
time frame: Change from baseline to 8 weeks.
description: By parent report, total number of contacts health care provider for their child in the past 8 weeks, other than previously scheduled check-ups, including emergency department visits, urgent care visits, and phone calls or messages to the doctor's office
measure: School absences
time frame: Change from baseline to 8 weeks.
description: By parent report, number of days of school the child has missed in the past 8 weeks (choices: 0, 1-3, 4-6, 7-10, more than 10 days). If on school break, parent asked to estimate as if school was in session--for example, how many days the child had to miss usual activities.
measure: Abdominal Pain Frequency
time frame: Change from baseline to 8 weeks.
description: How many days did the respondent experience pain in the past week, with options being never, 1-2 days, 3-4 days, 5-6 days, or daily, with greater frequency of pain being worse. Adapted from the Abdominal Pain Index, with permission.
measure: IMPACT-III
time frame: Change from baseline to secondary time point at 16 weeks.
description: Pediatric inflammatory bowel disease-specific health-related quality of life measure. "IMPACT" is not an abbreviation, but rather the name of the scale. Minimum score 0 to maximum score 100, with higher signifying better quality of life. Subjects get a total score (0 to 100) and a score for each of six subscales (0 to 100): Bowel Symptoms (7 items), Treatment/Interventions (3 items), Social Functioning (12 items), Emotional Functioning (7 items), Body Image (3 items), Systemic Symptoms (3 items). Each of the 35 total items has five multiple choice options and is given a score of 0, 25, 50, 75, or 100 points. The subscale scores are an average of the scores for each item that corresponds to that subscale. The total score is an average of all item scores.
measure: PedsQL 4.0 Generic Core Scale, Parent Proxy
time frame: Change from baseline to secondary time point at 16 weeks.
description: "PedsQL" refers to Pediatric Quality of Life. This is a pediatric 23-item measure of health-related quality of life. Questions fall under one of five domains: Physical Functioning (8 items), Emotional Functioning (5), Social Functioning (5 items), School Functioning (5 items). Yields a total score and two summary scores-Physical Health (comprised of physical functioning domain) and Psychosocial Health (comprised of each item in the 5-item emotional, social, and school functioning domains). Each item is rated on a 5-point Likert scale. Total score and the two summary scores are linearly transformed into a 0 to 100 point scale, with higher scores representing better quality of life.
measure: Modified Cantril Ladder
time frame: change over time monitored weekly for 8 weeks then at secondary time point at 16 weeks
description: Single item quality of life measure. From 0 to 10, with 10 representing the best quality of life.
arm group label: Hypnosis Intervention
arm group type: Experimental
description: The intervention is clinical hypnosis--a single in-person session followed by instructions to listen to audio recordings at home. The sessions consist of the provider's voice guiding the participant into a relaxed and focused state and providing therapeutic suggestions--for example, to replace discomfort with a more pleasant sensation, to ease anxiety, and to increase energy.
arm group label: Waitlist Control
arm group type: No Intervention
description: This group will serve as a control comparison and be offered the intervention after control data collection is complete.
intervention type: Behavioral
intervention name: Clinical Hypnosis
description: See information in arm/group description. Four different audio recordings are provided electronically, each approximately 20 minutes in length. Participants are encouraged to listen to one daily.
arm group label: Hypnosis Intervention
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: No
last name: Amanda D Lee, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
citation: Stone AL, Walker LS, Laird KT, Shirkey KC, Smith CA. Pediatric Pain Beliefs Questionnaire: Psychometric Properties of the Short Form. J Pain. 2016 Sep;17(9):1036-44. doi: 10.1016/j.jpain.2016.06.006. Epub 2016 Jun 27.
PMID: 27363626
citation: Forrest CB, Meltzer LJ, Marcus CL, de la Motte A, Kratchman A, Buysse DJ, Pilkonis PA, Becker BD, Bevans KB. Development and validation of the PROMIS Pediatric Sleep Disturbance and Sleep-Related Impairment item banks. Sleep. 2018 Jun 1;41(6). doi: 10.1093/sleep/zsy054.
PMID: 29546286
citation: Zhang YZ, Li YY. Inflammatory bowel disease: pathogenesis. World J Gastroenterol. 2014 Jan 7;20(1):91-9. doi: 10.3748/wjg.v20.i1.91.
PMID: 24415861
citation: Mackner LM, Greenley RN, Szigethy E, Herzer M, Deer K, Hommel KA. Psychosocial issues in pediatric inflammatory bowel disease: report of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2013 Apr;56(4):449-58. doi: 10.1097/MPG.0b013e3182841263.
PMID: 23287808
citation: Kunz JH, Hommel KA, Greenley RN. Health-related quality of life of youth with inflammatory bowel disease: a comparison with published data using the PedsQL 4.0 generic core scales. Inflamm Bowel Dis. 2010 Jun;16(6):939-46. doi: 10.1002/ibd.21128.
PMID: 19998462
citation: Vlieger AM, Menko-Frankenhuis C, Wolfkamp SC, Tromp E, Benninga MA. Hypnotherapy for children with functional abdominal pain or irritable bowel syndrome: a randomized controlled trial. Gastroenterology. 2007 Nov;133(5):1430-6. doi: 10.1053/j.gastro.2007.08.072. Epub 2007 Sep 2.
PMID: 17919634
citation: Palsson OS. Hypnosis Treatment of Gastrointestinal Disorders: A Comprehensive Review of the Empirical Evidence. Am J Clin Hypn. 2015 Oct;58(2):134-58. doi: 10.1080/00029157.2015.1039114.
PMID: 26264539
citation: Bonaz BL, Bernstein CN. Brain-gut interactions in inflammatory bowel disease. Gastroenterology. 2013 Jan;144(1):36-49. doi: 10.1053/j.gastro.2012.10.003. Epub 2012 Oct 12.
PMID: 23063970
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Amanda Lee
investigator title: Clinical Fellow
mesh term: Crohn Disease
sharing ipd: No