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Hypnosis for Children Undergoing Anorectal Manometry

Primary Purpose

Constipation

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypnosis
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Constipation focused on measuring hypnosis, anorectal manometry, child

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children aged 4-18 who are scheduled to undergo anorectal manometry testinf.
  • ASA classification I to II.
  • Both parents and children have sufficient English language proficiency.
  • Both parents and children are willing to fill out the questionnaires involved in this study.

Exclusion Criteria:

  • ASA classification III, IV (children with a chronic or severe disease).
  • Children with a metabolic, endocrine or neuromuscular disorder or mental illness.
  • Children with anorectal malformations or previous anorectal surgery.
  • Children with developmental delay
  • Children with diagnosed emotional or behavioral disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Hypnosis

    Control

    Arm Description

    A brief session of hypnosis just before child starts with anorectal manometry

    No hypnosis session, standard care

    Outcomes

    Primary Outcome Measures

    The primary outcome of this study will be the assessment of distress as measured by the non-blinded observer.
    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.

    Secondary Outcome Measures

    Periprocedural distress as measured by the blinded observer
    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.
    Child-reported levels of distress
    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).
    Parent-reported levels of distress
    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).
    Difficulty of procedure
    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).
    Difficulty of hypnosis
    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).
    Manometry outcomes
    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.

    Full Information

    First Posted
    June 30, 2020
    Last Updated
    July 10, 2020
    Sponsor
    Nationwide Children's Hospital
    Collaborators
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04471857
    Brief Title
    Hypnosis for Children Undergoing Anorectal Manometry
    Official Title
    Using Medical Hypnotherapy in Children With Defecation Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Terminated
    Why Stopped
    Due to COVID-19 recruitement stopped since intended sample size was an estimation and not based on power calculation
    Study Start Date
    January 9, 2017 (Actual)
    Primary Completion Date
    March 4, 2020 (Actual)
    Study Completion Date
    March 4, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nationwide Children's Hospital
    Collaborators
    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Partially blinded randomized controlled trial investigating the effect of a brief session of hypnosis prior to anorectal manometry in children

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Constipation
    Keywords
    hypnosis, anorectal manometry, child

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    A blinded observer assessed child distress during anorectal manometry
    Allocation
    Randomized
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hypnosis
    Arm Type
    Experimental
    Arm Description
    A brief session of hypnosis just before child starts with anorectal manometry
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    No hypnosis session, standard care
    Intervention Type
    Behavioral
    Intervention Name(s)
    Hypnosis
    Primary Outcome Measure Information:
    Title
    The primary outcome of this study will be the assessment of distress as measured by the non-blinded observer.
    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.
    Time Frame
    Periprocedural
    Secondary Outcome Measure Information:
    Title
    Periprocedural distress as measured by the blinded observer
    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.
    Time Frame
    Periprocedural
    Title
    Child-reported levels of distress
    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).
    Time Frame
    Right after anorectal manometry (same day)
    Title
    Parent-reported levels of distress
    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).
    Time Frame
    Right after anorectal manometry (same day)
    Title
    Difficulty of procedure
    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).
    Time Frame
    Right after anorectal manometry (same day)
    Title
    Difficulty of hypnosis
    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).
    Time Frame
    Right after anorectal manometry (same day)
    Title
    Manometry outcomes
    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.
    Time Frame
    Periprocedural

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children aged 4-18 who are scheduled to undergo anorectal manometry testinf. ASA classification I to II. Both parents and children have sufficient English language proficiency. Both parents and children are willing to fill out the questionnaires involved in this study. Exclusion Criteria: ASA classification III, IV (children with a chronic or severe disease). Children with a metabolic, endocrine or neuromuscular disorder or mental illness. Children with anorectal malformations or previous anorectal surgery. Children with developmental delay Children with diagnosed emotional or behavioral disorders

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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