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Clinical Trials/NCT05611346
NCT05611346RecruitingNot Applicable

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

Centre Hospitalier Universitaire de la Réunion2 sites in 1 country32 target enrollmentStarted: August 13, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
32
Locations
2
Primary Endpoint
Asses the patient recruitment rate

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
8 Years to 17 Years (Child)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

Asses the patient recruitment rate

Time Frame: 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 Outcomes

  • Assess patient compliance with self-hypnosis practice(At 1 month, 3 months, and 6 months after inclusion)
  • Patient satisfaction(At 1 month, 3 months, and 6 months after inclusion)
  • Improvements to the hypnosis program(At 6 months after inclusion)
  • Parents' overall impression(At 1 month, 3 months, and 6 months after enrollment)
  • Patient lost sight of(At 1 month, 3 months, and 6 months after inclusion)
  • Effectiveness(At 1 month, 3 months, and 6 months after inclusion)

Investigators

Sponsor
Centre Hospitalier Universitaire de la Réunion
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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