<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/NCT04471857</url>
  </required_header>
  <id_info>
    <org_study_id>IRB15-00864</org_study_id>
    <nct_id>NCT04471857</nct_id>
  </id_info>
  <brief_title>Hypnosis for Children Undergoing Anorectal Manometry</brief_title>
  <official_title>Using Medical Hypnotherapy in Children With Defecation Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nationwide Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nationwide Children's Hospital</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>
      Partially blinded randomized controlled trial investigating the effect of a brief session of&#xD;
      hypnosis prior to anorectal manometry in children&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to COVID-19 recruitement stopped since intended sample size was an estimation and not based&#xD;
    on power calculation&#xD;
  </why_stopped>
  <start_date type="Actual">January 9, 2017</start_date>
  <completion_date type="Actual">March 4, 2020</completion_date>
  <primary_completion_date type="Actual">March 4, 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>Single (Outcomes Assessor)</masking>
    <masking_description>A blinded observer assessed child distress during anorectal manometry</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The primary outcome of this study will be the assessment of distress as measured by the non-blinded observer.</measure>
    <time_frame>Periprocedural</time_frame>
    <description>The non-blinded observer will use the Observation Scale of Behavioral Distress (OSBD) to assess the periprocedural distress of the child. The OSBD records the presence or absence of thirteen operationally-defined behaviors, which indicate discomfort (e.g. cry, verbal resistance, information seeking) at 15-second intervals throughout the procedure. The behaviors are given a score ranging from 1 to 4 according to the severity of distress that is expressed by that behavior. The recorded score during a 15-second interval can range from zero (no distress) to 33.5 (extreme distress). The total scores will be summed up and then divided by the number of 15-second intervals to obtain a mean distress score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Periprocedural distress as measured by the blinded observer</measure>
    <time_frame>Periprocedural</time_frame>
    <description>The blinded observer rates the child's distress on a 4-point Likert scale ranging from 0 (not anxious at all) to 3 (extremely anxious). Ratings are based on facial features, crying, and physical movements. The blinded observer reports the highest (i.e. peak), most common (i.e. typical),and the lowest level of distress. We will compare the highest and most common levels of distress between groups, as we believed these levels of distress are most clinically relevant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child-reported levels of distress</measure>
    <time_frame>Right after anorectal manometry (same day)</time_frame>
    <description>The child will be asked to rate the amount of distress experienced (unpleasantness, nervousness, and anxiety) during the manometry on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). They are also asked to rate the pain of the procedure on an analogous scale of 0 (no pain) to 10 (extremely painful). Children who received hypnosis are asked if they believed that it helped them to relax on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent-reported levels of distress</measure>
    <time_frame>Right after anorectal manometry (same day)</time_frame>
    <description>The parent accompanying the child will be asked to rate the amount of distress of the child (unpleasantness, nervousness, and anxiety) during the manometry on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). They are also asked to rate the pain of the procedure on an analogous scale of 0 (no pain) to 10 (extremely painful). Parents of children who received hypnosis are asked if they believed that it helped the child to relax on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difficulty of procedure</measure>
    <time_frame>Right after anorectal manometry (same day)</time_frame>
    <description>The motility nurse will report if all parts of the procedure could be performed properly and rates the degree of difficulty of the procedure on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difficulty of hypnosis</measure>
    <time_frame>Right after anorectal manometry (same day)</time_frame>
    <description>The hypnotherapist rates the degree of difficulty of the hypnosis on a similar 5-point Likert scale ranging from 0 (not at all) to 4 (very much).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Manometry outcomes</measure>
    <time_frame>Periprocedural</time_frame>
    <description>Procedural outcomes of the children undergoing anorectal manometry will be recorded and compared between groups. This includes: resting pressure, squeeze pressure, squeeze duration, push test, duration of procedure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>Hypnosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A brief session of hypnosis just before child starts with anorectal manometry</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No hypnosis session, standard care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Hypnosis</intervention_name>
    <arm_group_label>Hypnosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 4-18 who are scheduled to undergo anorectal manometry testinf.&#xD;
&#xD;
          -  ASA classification I to II.&#xD;
&#xD;
          -  Both parents and children have sufficient English language proficiency.&#xD;
&#xD;
          -  Both parents and children are willing to fill out the questionnaires involved in this&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA classification III, IV (children with a chronic or severe disease).&#xD;
&#xD;
          -  Children with a metabolic, endocrine or neuromuscular disorder or mental illness.&#xD;
&#xD;
          -  Children with anorectal malformations or previous anorectal surgery.&#xD;
&#xD;
          -  Children with developmental delay&#xD;
&#xD;
          -  Children with diagnosed emotional or behavioral disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</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 15, 2020</study_first_posted>
  <last_update_submitted>July 10, 2020</last_update_submitted>
  <last_update_submitted_qc>July 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Frederick Woodley</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>hypnosis</keyword>
  <keyword>anorectal manometry</keyword>
  <keyword>child</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</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/NCT04471857
org study id: IRB15-00864
nct id: NCT04471857
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Partially blinded randomized controlled trial investigating the effect of a brief session of
      hypnosis prior to anorectal manometry in children
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: A blinded observer assessed child distress during anorectal manometry
measure: The primary outcome of this study will be the assessment of distress as measured by the non-blinded observer.
time frame: Periprocedural
description: The non-blinded observer will use the Observation Scale of Behavioral Distress (OSBD) to assess the periprocedural distress of the child. The OSBD records the presence or absence of thirteen operationally-defined behaviors, which indicate discomfort (e.g. cry, verbal resistance, information seeking) at 15-second intervals throughout the procedure. The behaviors are given a score ranging from 1 to 4 according to the severity of distress that is expressed by that behavior. The recorded score during a 15-second interval can range from zero (no distress) to 33.5 (extreme distress). The total scores will be summed up and then divided by the number of 15-second intervals to obtain a mean distress score.
measure: Periprocedural distress as measured by the blinded observer
time frame: Periprocedural
description: The blinded observer rates the child's distress on a 4-point Likert scale ranging from 0 (not anxious at all) to 3 (extremely anxious). Ratings are based on facial features, crying, and physical movements. The blinded observer reports the highest (i.e. peak), most common (i.e. typical),and the lowest level of distress. We will compare the highest and most common levels of distress between groups, as we believed these levels of distress are most clinically relevant.
measure: Child-reported levels of distress
time frame: Right after anorectal manometry (same day)
description: The child will be asked to rate the amount of distress experienced (unpleasantness, nervousness, and anxiety) during the manometry on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). They are also asked to rate the pain of the procedure on an analogous scale of 0 (no pain) to 10 (extremely painful). Children who received hypnosis are asked if they believed that it helped them to relax on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).
measure: Parent-reported levels of distress
time frame: Right after anorectal manometry (same day)
description: The parent accompanying the child will be asked to rate the amount of distress of the child (unpleasantness, nervousness, and anxiety) during the manometry on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). They are also asked to rate the pain of the procedure on an analogous scale of 0 (no pain) to 10 (extremely painful). Parents of children who received hypnosis are asked if they believed that it helped the child to relax on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).
measure: Difficulty of procedure
time frame: Right after anorectal manometry (same day)
description: The motility nurse will report if all parts of the procedure could be performed properly and rates the degree of difficulty of the procedure on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).
measure: Difficulty of hypnosis
time frame: Right after anorectal manometry (same day)
description: The hypnotherapist rates the degree of difficulty of the hypnosis on a similar 5-point Likert scale ranging from 0 (not at all) to 4 (very much).
measure: Manometry outcomes
time frame: Periprocedural
description: Procedural outcomes of the children undergoing anorectal manometry will be recorded and compared between groups. This includes: resting pressure, squeeze pressure, squeeze duration, push test, duration of procedure.
arm group label: Hypnosis
arm group type: Experimental
description: A brief session of hypnosis just before child starts with anorectal manometry
arm group label: Control
arm group type: No Intervention
description: No hypnosis session, standard care
intervention type: Behavioral
intervention name: Hypnosis
arm group label: Hypnosis
criteria: 
gender: All
minimum age: 4 Years
maximum age: 18 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Frederick Woodley
investigator title: PhD
mesh term: Constipation
sharing ipd: No