HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers

Study Overview
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Brief Summary
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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.

Official Title
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HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers : Study Protocol of a Pilot Randomized and Controlled Trial

Conditions
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Dermatitis

Intervention / Treatment
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* Behavioral: Hypnosis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Therapeutic education program<br> | |
| Experimental: Therapeutic education program and Hypnosis<br> | Behavioral: Hypnosis<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Recruitment | Evaluate the patient recruitment rate in a pilot, randomized controlled study proposing a hypnosis program to children with moderate to severe AD. | 24 months |