HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Asses the patient recruitment rate [Срок оценки: 24 months]

Вторичные конечные точки (6)

• Assess patient compliance with self-hypnosis practice [Срок оценки: At 1 month, 3 months, and 6 months after inclusion]
• Patient lost sight of [Срок оценки: At 1 month, 3 months, and 6 months after inclusion]
• Patient satisfaction [Срок оценки: At 1 month, 3 months, and 6 months after inclusion]
• Improvements to the hypnosis program [Срок оценки: At 6 months after inclusion]
• Effectiveness [Срок оценки: At 1 month, 3 months, and 6 months after inclusion]
• Parents' overall impression [Срок оценки: At 1 month, 3 months, and 6 months after enrollment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Reunion · 1 центр

• CHU de la Réunion — Saint-Denis

Публикации

• Thysebaert Z, Espagnon C, Bocquet V, Bruneau L, Miquel J. Applying medical hypnosis in the management of atopic dermatitis in children and young adolescents: study protocol for a pilot cluster randomised controlled trial (Hypno-AD). BMJ Open. 2026 Mar 18;16(3):e110921. doi: 10.1136/bmjopen-2025-110921. PMID 41857860

Идентификаторы

NCT: NCT05611346 · 2022/CHU/15

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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