HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers

Not Applicable

Recruiting

• Conditions: Dermatitis

• Registration Number: NCT05611346
• Lead Sponsor: Centre Hospitalier Universitaire de la Réunion

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-03
• Study First Submitted QC: 2022-11-03
• Study First Posted: 2022-11-10
• Study Start: 2024-08-13
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-08
• Last Update Posted: 2025-09-12
• Primary Completion: 2027-02
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Asses the patient recruitment rate	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 Outcome Measures

Name	Time	Method
Assess patient compliance with self-hypnosis practice	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
Patient satisfaction	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
Improvements to the hypnosis program	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.
Parents' overall impression	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
Patient lost sight of	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
Effectiveness	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)

Trial Locations

Locations (1)

CHU de la Réunion; 🇷🇪 Saint-Denis, Reunion