HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers (HypnoDA)

September 8, 2025 updated by: Centre Hospitalier Universitaire de la Réunion

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess patient compliance with self-hypnosis practice
Time Frame: 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
At 1 month, 3 months, and 6 months after inclusion
Patient lost sight of
Time Frame: 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
At 1 month, 3 months, and 6 months after inclusion
Patient satisfaction
Time Frame: 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
At 1 month, 3 months, and 6 months after inclusion
Improvements to the hypnosis program
Time Frame: 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.
At 6 months after inclusion
Effectiveness
Time Frame: 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)
At 1 month, 3 months, and 6 months after inclusion
Parents' overall impression
Time Frame: 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
At 1 month, 3 months, and 6 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Réunion

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 3, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/CHU/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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