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NCT Number: NCT05611346

HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers

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.

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Key information

Conditions

Dermatitis Skin Diseases Skin and Connective Tissue Diseases

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de la Réunion

Saint-Denis, 97400, Reunion

Location status: Recruiting

Location contact

Camille ESPAGNON, MD

CONTACT

[email protected]

Camille ESPAGNON, MD

SUB_INVESTIGATOR

Juliette MIQUEL, MD

CONTACT

[email protected]

Juliette MIQUEL, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Asses the patient recruitment rate

    Time frame: 24 months

    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.

Secondary outcomes

  1. Assess patient compliance with self-hypnosis practice

    Time frame: At 1 month, 3 months, and 6 months after inclusion

    Assess patients' adherence to self-hypnosis practice at home, on a self-reported basis, using an adherence log in the experimental arm by:

    • The adherence rate at M1
    • The variation in the adherence rate over time

  2. Patient lost sight of

    Time frame: At 1 month, 3 months, and 6 months after inclusion

    Evaluate the rate of patient who has been lost sight of(M1, M3, M6) in both arms, measured by the proportion of patients lost sight of/number of patients included at baseline

  3. Patient satisfaction

    Time frame: At 1 month, 3 months, and 6 months after inclusion

    Assess patient satisfaction with the hypnosis program in the experimental arm using a satisfaction questionnaire

  4. Improvements to the hypnosis program

    Time frame: At 6 months after inclusion

    Describe possible improvements to the hypnosis program in the experimental arm at M6 through focus group interviews with a group of volunteers aged 8-11 and a group of volunteers aged 12-17.

  5. Effectiveness

    Time frame: At 1 month, 3 months, and 6 months after inclusion

    Evaluate the effectiveness of a hypnosis program (exploratory)

    • On the control of atopic dermatitis ( The change in the mean AD control score, measured by the ADCT)
    • On the severity of atopic dermatitis (The change in the mean AD severity score, measured by the PO-SCORAD)

  6. Parents' overall impression

    Time frame: At 1 month, 3 months, and 6 months after enrollment

    Assess parents' overall impression of their child's AD progress with the hypnosis program, via a questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Camille ESPAGNON, MD

CONTACT

[email protected]

Juliette MIQUEL, MD

CONTACT

[email protected]

+262 262 35 90 00

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Official study title

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

Acronym: HypnoDA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 10, 2022
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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