HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers

Dermatitis Clinical Trial

— HypnoDA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05611346
• Other study ID #: 2022/CHU/15
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

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