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Recruiting NCT05611346

NCT05611346 HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers

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Clinical Trial Summary
NCT ID NCT05611346
Status Recruiting
Phase
Sponsor Centre Hospitalier Universitaire de la Réunion
Condition Dermatitis
Study Type INTERVENTIONAL
Enrollment 32 participants
Start Date 2024-08-13
Primary Completion 2027-02

Eligibility & Interventions

Sex All sexes
Min Age 8 Years
Max Age 17 Years
Study Type INTERVENTIONAL
Interventions
Hypnosis

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 32 participants in total. It began in 2024-08-13 with a primary completion date of 2027-02.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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.

Contact & Investigator

Central Contact

Juliette MIQUEL, MD

✉ juliette.miquel@chu-reunion.fr

📞 +262 262 35 90 00

Principal Investigator

Juliette MIQUEL, MD

PRINCIPAL INVESTIGATOR

CHU de la Réunion

Frequently Asked Questions

Who can join the NCT05611346 clinical trial?

This trial is open to participants of all sexes, aged 8 Years or older, up to 17 Years, studying Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05611346 currently recruiting?

Yes, NCT05611346 is actively recruiting participants. Contact the research team at juliette.miquel@chu-reunion.fr for enrollment information.

Where is the NCT05611346 trial being conducted?

This trial is being conducted at Saint-Denis, Reunion.

Who is sponsoring the NCT05611346 clinical trial?

NCT05611346 is sponsored by Centre Hospitalier Universitaire de la Réunion. The principal investigator is Juliette MIQUEL, MD at CHU de la Réunion. The trial plans to enroll 32 participants.

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