- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04829578
Hypnosis for Chronic Idiopathic Pruritus
January 11, 2024 updated by: Centre Hospitalier Universitaire de Nice
A Prospective Study of Hypnosis for Chronic Idiopathic Pruritus
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nice, France, 06000
- CHU de Nice
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Hypnosis
hyspnosis treatment
|
Chronic idiopathic pruritus is treated by hypnosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Pruritus Numeric Rating Scale
Time Frame: Day 84
|
Assessment of the intensity of pruritis in Pruritus Numeric Rating Scal; the minimum and maximum values 0 to 10
|
Day 84
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Pruritus Verbal Rating Scale
Time Frame: Day 84
|
Assessment of Pruritus by pruritus Verbal Rating Scale; the minimum and maximum values 0 to 4
|
Day 84
|
Change From Baseline in Sleeping Scale
Time Frame: Day 84
|
assessment in sleeping scale ; the minimum and maximum values 0 to 10
|
Day 84
|
Change From Baseline in DLQI scale
Time Frame: Day 84
|
assessment in DLQI scale; result between 0 to 30
|
Day 84
|
Change From Baseline in HAD scale
Time Frame: Day 84
|
assessment in HAD scale; result between 0 to 42
|
Day 84
|
Change From Baseline in usage of topical steroids
Time Frame: Day 84
|
assessment in usage of topical steroids
|
Day 84
|
Evaluation of tolerance of hypnosis
Time Frame: Day 84
|
assessment of tolerance of hypnosis with report of adverse event
|
Day 84
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: BAHADORAN PHILIPPE, Centre Hospitalier Universitaire de Nice
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 13, 2021
Primary Completion (Actual)
September 13, 2021
Study Completion (Actual)
October 31, 2022
Study Registration Dates
First Submitted
March 26, 2021
First Submitted That Met QC Criteria
March 31, 2021
First Posted (Actual)
April 2, 2021
Study Record Updates
Last Update Posted (Actual)
January 12, 2024
Last Update Submitted That Met QC Criteria
January 11, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-AOIP-01
- 2020-A03263-36 (Other Identifier: CHU de Nice)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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