HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers

NCT ID: NCT05611346

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-13

Study Completion Date

2027-12-31

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.

Detailed Description

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Conditions

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Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Therapeutic education program

Group Type NO_INTERVENTION

No interventions assigned to this group

Therapeutic education program and Hypnosis

Group Type EXPERIMENTAL

Hypnosis

Intervention Type BEHAVIORAL

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

Interventions

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Hypnosis

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Children aged 8 to 17 years
* Understanding french
* Have a clinical diagnosis of mild-to-severe AD with a SCORing Atopic Dermatitis (SCORAD)
* 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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juliette MIQUEL, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de la Réunion

Locations

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CHU de la Réunion

Saint-Denis, , Reunion

Site Status RECRUITING

Countries

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Reunion

Central Contacts

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Juliette MIQUEL, MD

Role: CONTACT

+262 262 35 90 00

Camille ESPAGNON, MD

Role: CONTACT

Facility Contacts

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Juliette MIQUEL, MD

Role: primary

Camille ESPAGNON, MD

Role: backup

Other Identifiers

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2022/CHU/15

Identifier Type: -

Identifier Source: org_study_id

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