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Hypnosis for Chronic Idiopathic Pruritus

Primary Purpose

Chronic Idiopathic Pruritus

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypnosis
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Idiopathic Pruritus

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female of at least 18 years at screening
  • Diagnosis of chronic (at least 6 wks.) idiopathic pruritus
  • Pruritus Numeric Rating Scale > = 4

Exclusion Criteria:

  • Pruritus caused by a dermatological or a systemic conditions
  • Suicidal crisis, moderate, or severe
  • Psychosis (schizophrenia, persistent delusional disorder)
  • Bipolar disorder, not stabilized or decompensating
  • Personality disorder, decompensated

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Hypnosis

    Arm Description

    hyspnosis treatment

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Pruritus Numeric Rating Scale
    Assessment of the intensity of pruritis in Pruritus Numeric Rating Scal; the minimum and maximum values 0 to 10

    Secondary Outcome Measures

    Change From Baseline in Pruritus Verbal Rating Scale
    Assessment of Pruritus by pruritus Verbal Rating Scale; the minimum and maximum values 0 to 4
    Change From Baseline in Sleeping Scale
    assessment in sleeping scale ; the minimum and maximum values 0 to 10
    Change From Baseline in DLQI scale
    assessment in DLQI scale; result between 0 to 30
    Change From Baseline in HAD scale
    assessment in HAD scale; result between 0 to 42
    Change From Baseline in usage of topical steroids
    assessment in usage of topical steroids
    Evaluation of tolerance of hypnosis
    assessment of tolerance of hypnosis with report of adverse event

    Full Information

    First Posted
    March 26, 2021
    Last Updated
    March 31, 2021
    Sponsor
    Centre Hospitalier Universitaire de Nice
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04829578
    Brief Title
    Hypnosis for Chronic Idiopathic Pruritus
    Official Title
    A Prospective Study of Hypnosis for Chronic Idiopathic Pruritus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2021 (Anticipated)
    Primary Completion Date
    July 1, 2021 (Anticipated)
    Study Completion Date
    October 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Nice

    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
    Chronic idiopathic pruritus (CIP) is a frequent and disabling condition, for which there is no specific treatment. It was shown previously that hypnosis can relieve painful sensations. Pain and pruritus share many similarities regarding sensory receptors and pathways, suggesting that hypnosis might help relief CIP.
    Detailed Description
    Chronic idiopathic pruritus (CIP) is a frequent and disabling condition, with significative impact on quality of life. At present, there is no specific treatment for CIP. Topical steroids are frequently used, with partial efficacy, and adverse effects. Hypnosis is a specific state of conscience. It differs from waking state, sleeping state, relaxation, or meditation. In this state, the person is highly responsive to suggestion. In medicine, hypnosis can be used to engage the internal resources of the person against unpleasant feelings. It was shown previously that hypnosis can relieve painful sensations. Pain and pruritus share many similarities regarding sensory receptors and pathways, suggesting that hypnosis might help relief CIP.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Idiopathic Pruritus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hypnosis
    Arm Type
    Other
    Arm Description
    hyspnosis treatment
    Intervention Type
    Other
    Intervention Name(s)
    Hypnosis
    Intervention Description
    Chronic idiopathic pruritus is treated by hypnosis
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Pruritus Numeric Rating Scale
    Description
    Assessment of the intensity of pruritis in Pruritus Numeric Rating Scal; the minimum and maximum values 0 to 10
    Time Frame
    Day 84
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Pruritus Verbal Rating Scale
    Description
    Assessment of Pruritus by pruritus Verbal Rating Scale; the minimum and maximum values 0 to 4
    Time Frame
    Day 84
    Title
    Change From Baseline in Sleeping Scale
    Description
    assessment in sleeping scale ; the minimum and maximum values 0 to 10
    Time Frame
    Day 84
    Title
    Change From Baseline in DLQI scale
    Description
    assessment in DLQI scale; result between 0 to 30
    Time Frame
    Day 84
    Title
    Change From Baseline in HAD scale
    Description
    assessment in HAD scale; result between 0 to 42
    Time Frame
    Day 84
    Title
    Change From Baseline in usage of topical steroids
    Description
    assessment in usage of topical steroids
    Time Frame
    Day 84
    Title
    Evaluation of tolerance of hypnosis
    Description
    assessment of tolerance of hypnosis with report of adverse event
    Time Frame
    Day 84

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female of at least 18 years at screening Diagnosis of chronic (at least 6 wks.) idiopathic pruritus Pruritus Numeric Rating Scale > = 4 Exclusion Criteria: Pruritus caused by a dermatological or a systemic conditions Suicidal crisis, moderate, or severe Psychosis (schizophrenia, persistent delusional disorder) Bipolar disorder, not stabilized or decompensating Personality disorder, decompensated
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    CAUSERET Marion
    Phone
    0492034702
    Email
    causeret.m@chu-nice.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    BAHADORAN PHILIPPE
    Organizational Affiliation
    Centre Hospitalier Universitaire de Nice
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Hypnosis for Chronic Idiopathic Pruritus

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