Dermatitis
Conditions
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.
Interventions
BEHAVIORALHypnosis
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
Sponsors
Centre Hospitalier Universitaire de la Réunion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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) |
| 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 |
| 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. |
Countries
Reunion
Contacts
Primary ContactJuliette MIQUEL, MD
Backup ContactCamille ESPAGNON, MD
Outcome results
None listed