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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05611346
Other study ID # 2022/CHU/15
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2024
Est. completion date May 2027

Study information

Verified date March 2024
Source Centre Hospitalier Universitaire de la Réunion
Contact Juliette MIQUEL, MD
Phone +262 262 35 90 00
Email juliette.miquel@chu-reunion.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 32
Est. completion date May 2027
Est. primary completion date November 2026
Accepts healthy volunteers No
Gender All
Age group 8 Years to 17 Years
Eligibility Inclusion Criteria: - Children aged 8 to 17 years - Understanding french - With moderate to severe AD clinically diagnosed by a physician (SCORing Atopic Dermatitis (SCORAD) = 25) - 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


Related Conditions & MeSH terms


Intervention

Behavioral:
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

Locations

Country Name City State
Réunion CHU de la Réunion Saint-Denis

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Recruitment Evaluate the patient recruitment rate in a pilot, randomized controlled study proposing a hypnosis program to children with moderate to severe AD. 24 months
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