ClinicalTrials.gg
Active, not recruitingNCT05611346HypnoDAUpdated Sep 24, 2026

HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers

An interventional study of Hypnosis in Dermatitis, sponsored by Centre Hospitalier Universitaire de la Réunion. Active, not recruiting at 1 site in Reunion. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Centre Hospitalier Universitaire de la Réunion · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
8 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dermatitis

Browse trials for

03

In context

Dermatitis

238 studies on the registry are indexed under Dermatitis; 34 are open to participants now.

This study's planned enrollment of 32 is below the median of 68 across 191 interventional studies indexed under Dermatitis.

Browse Dermatitis studies →

Lead sponsor

Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 to hypnosis (psychiatric disorders, psychosis)
  • Treated by a systemic treatment for their AD.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • No intervention
    Therapeutic education program
  • Experimental
    Therapeutic education program and Hypnosis

    Behavioral: Hypnosis

Interventions

  • BehavioralHypnosis

    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

06

What researchers measure

Primary outcomes

  1. Asses the patient recruitment rate

    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.

    Time frame: 24 months

Secondary outcomes

  1. Assess patient compliance with self-hypnosis practice

    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

    Time frame: At 1 month, 3 months, and 6 months after inclusion

  2. Patient lost sight of

    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

    Time frame: At 1 month, 3 months, and 6 months after inclusion

  3. Patient satisfaction

    Assess patient satisfaction with the hypnosis program in the experimental arm using a satisfaction questionnaire

    Time frame: At 1 month, 3 months, and 6 months after inclusion

  4. Improvements to the hypnosis program

    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.

    Time frame: At 6 months after inclusion

  5. Effectiveness

    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)

    Time frame: At 1 month, 3 months, and 6 months after inclusion

  6. Parents' overall impression

    Assess parents' overall impression of their child's AD progress with the hypnosis program, via a questionnaire

    Time frame: At 1 month, 3 months, and 6 months after enrollment

07

Study locations

1 site
08

References and documents

Publications

  • Thysebaert Z, Espagnon C, Bocquet V, Bruneau L, Miquel J. Applying medical hypnosis in the management of atopic dermatitis in children and young adolescents: study protocol for a pilot cluster randomised controlled trial (Hypno-AD). BMJ Open. 2026 Mar 18;16(3):e110921. doi: 10.1136/bmjopen-2025-110921. PubMed 41857860 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2024 (actual). Primary completion is estimated for Feb 2027, 30 months after the start.

Of 36 interventional studies with no phase under Dermatitis, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 13. This study's planned 30 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 2022
First posted
Nov 10, 2022
StartActual
Aug 13, 2024
Primary completionEst.
Feb 2027
CompletionEst.
Feb 2027
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05611346
Responsible party
Sponsor
First posted
Nov 10, 2022
Start date
Aug 13, 2024
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Sep 24, 2026

Study contacts

Juliette MIQUEL, MD
principal investigator · CHU de la Réunion

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion