HypnoDA: HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers

Sponsor
Centre Hospitalier Universitaire de la Réunion (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05611346
Collaborator
(none)
32
1
2
26.9
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Hypnosis
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers : Study Protocol of a Pilot Randomized and Controlled Trial
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Therapeutic education program

Experimental: Therapeutic education program and Hypnosis

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

Outcome Measures

Primary Outcome Measures

  1. Patient Recruitment [24 months]

    Evaluate the patient recruitment rate in a pilot, randomized controlled study proposing a hypnosis program to children with moderate to severe AD.

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de la Réunion Saint-Denis Réunion 97400

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de la Réunion

Investigators

  • Principal Investigator: Juliette MIQUEL, MD, CHU de la Réunion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier:
NCT05611346
Other Study ID Numbers:
  • 2022/CHU/15
First Posted:
Nov 10, 2022
Last Update Posted:
Jan 9, 2023
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 9, 2023