HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers

NCT05611346 | Recruiting

• 1 other identifier: 2022/CHU/15
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis

Outcome Measures

Primary Outcomes (1)

• Asses the patient recruitment rate

  The recruitment rate is the proportion of patients recruited into the pilot study: number of patients included/number of patients to whom the study was proposed.

  24 months

Secondary Outcomes (6)

• Assess patient compliance with self-hypnosis practice

  At 1 month, 3 months, and 6 months after inclusion

• Patient lost sight of

  At 1 month, 3 months, and 6 months after inclusion

• Patient satisfaction

  At 1 month, 3 months, and 6 months after inclusion

• Improvements to the hypnosis program

  At 6 months after inclusion

• Effectiveness

  At 1 month, 3 months, and 6 months after inclusion

Study Arms (2)

Therapeutic education program

NO INTERVENTION

Therapeutic education program and Hypnosis

EXPERIMENTAL

Behavioral: Hypnosis

Interventions

Hypnosis 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

Therapeutic education program and Hypnosis

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children refusing to participate in the hypnosis session
• Not having the possibility to listen to an audio file,
• Having a contraindication to hypnosis (psychiatric disorders, psychosis)
• Treated by a systemic treatment for their AD.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

CHU de la Réunion

Saint-Denis, 97400, Reunion

RECRUITING

MeSH Terms

Conditions

Dermatitis

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Juliette MIQUEL, MD

  CHU de la Réunion

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliette MIQUEL, MD

CONTACT

+262 262 35 90 00; juliette.miquel@chu-reunion.fr

Camille ESPAGNON, MD

CONTACT

camille.espagnon@laposte.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 10, 2022
• Study Start: August 13, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

RE (1)