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HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers (HypnoDA)

Primary Purpose

Dermatitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Réunion
Study Type
Interventional
Intervention
Hypnosis
Sponsored by
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dermatitis

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children aged 8 to 17 years Understanding french With moderate to severe AD clinically diagnosed by a physician (SCORing Atopic Dermatitis (SCORAD) ≥ 25) Referred by their referring physician in the Reunionese therapeutic education program for AD provided within the atopy school of the Reunion University Hospital. - Oral consent of the child and of one of the legal representatives collected. Exclusion Criteria: Children refusing to participate in the hypnosis session Not having the possibility to listen to an audio file, Already practicing self-hypnosis for their AD before inclusion, Having a contraindication to hypnosis (psychiatric disorders, psychosis) Treated by a systemic treatment for their AD.

Sites / Locations

  • CHU de la Réunion

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Therapeutic education program

Therapeutic education program and Hypnosis

Arm Description

Outcomes

Primary Outcome Measures

Patient Recruitment
Evaluate the patient recruitment rate in a pilot, randomized controlled study proposing a hypnosis program to children with moderate to severe AD.

Secondary Outcome Measures

Full Information

First Posted
November 3, 2022
Last Updated
January 6, 2023
Sponsor
Centre Hospitalier Universitaire de la Réunion
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1. Study Identification

Unique Protocol Identification Number
NCT05611346
Brief Title
HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers
Acronym
HypnoDA
Official Title
HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers : Study Protocol of a Pilot Randomized and Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

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

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
Atopic dermatitis (AD) is a chronic inflammatory dermatosis, common in children. It causes pruritus and skin lesions that can have a significant impact on patients' quality of life. AD can be difficult to treat because of its chronicity, demanding local care, corticophobia and the financial cost of non-reimbursed products. Patients are often looking for therapeutic alternatives. Medical hypnosis is a therapeutic alternative via hypnoanalgesia induced by direct suggestions of comfort and skin soothing and via anxiolysis, by working on stress management and self-esteem reinforcement. Four studies are interested in its action in AD and seem to show a reduction in pruritus, skin pain, an improvement in the intensity of atopic dermatitis, sleep, mood and for some a cure of AD. These results are encouraging but limited by the absence of a control group or by the small population included. Therefore, we propose in a first step to evaluate the feasibility of an hypnosis program through a pilot study, designed in the miniature format of a future, larger scale, randomized controlled trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic education program
Arm Type
No Intervention
Arm Title
Therapeutic education program and Hypnosis
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Hypnosis
Intervention Description
The experimental group will receive 2 standardized hypnosis sessions via the "superhero costume" technique performed during this collective therapeutic education program, completed by a reinforcement through the practice of self-hypnosis at home guided by the listening of an audio recording
Primary Outcome Measure Information:
Title
Patient Recruitment
Description
Evaluate the patient recruitment rate in a pilot, randomized controlled study proposing a hypnosis program to children with moderate to severe AD.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children aged 8 to 17 years Understanding french With moderate to severe AD clinically diagnosed by a physician (SCORing Atopic Dermatitis (SCORAD) ≥ 25) Referred by their referring physician in the Reunionese therapeutic education program for AD provided within the atopy school of the Reunion University Hospital. - Oral consent of the child and of one of the legal representatives collected. Exclusion Criteria: Children refusing to participate in the hypnosis session Not having the possibility to listen to an audio file, Already practicing self-hypnosis for their AD before inclusion, Having a contraindication to hypnosis (psychiatric disorders, psychosis) Treated by a systemic treatment for their AD.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juliette MIQUEL, MD
Phone
+262 262 35 90 00
Email
juliette.miquel@chu-reunion.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Camille ESPAGNON, MD
Email
camille.espagnon@laposte.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliette MIQUEL, MD
Organizational Affiliation
CHU de la Réunion
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de la Réunion
City
Saint-Denis
ZIP/Postal Code
97400
Country
Réunion
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliette MIQUEL, MD
Email
juliette.miquel@chu-reunion.fr
First Name & Middle Initial & Last Name & Degree
Camille ESPAGNON, MD
Email
camille.espagnon@laposte.net
First Name & Middle Initial & Last Name & Degree
Juliette MIQUEL, MD
First Name & Middle Initial & Last Name & Degree
Camille ESPAGNON, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers

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