DermatitisHypnoDANCT05611346
HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers
A study testing Hypnosis in people with Dermatitis, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Dermatitis
- What is being tested?
- Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteReunion
- Study dates
- 13 Aug 2024to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dermatitis
- Being tested
- Hypnosis
- Medical subject headings
- Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic education program | No intervention | Not described |
| Therapeutic education program and Hypnosis | Experimental | Not described Receives: Behavioral: Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (6)
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
Measured: At 1 month, 3 months, and 6 months after inclusion
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
Measured: At 1 month, 3 months, and 6 months after inclusion
Patient satisfaction
Assess patient satisfaction with the hypnosis program in the experimental arm using a satisfaction questionnaire
Measured: At 1 month, 3 months, and 6 months after inclusion
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.
Measured: At 6 months after inclusion
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)
Measured: At 1 month, 3 months, and 6 months after inclusion
Parents' overall impression
Assess parents' overall impression of their child's AD progress with the hypnosis program, via a questionnaire
Measured: At 1 month, 3 months, and 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start13 Aug 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliette MIQUEL, MD, Principal investigator, CHU de la Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611346
- Sponsor's protocol ID
- 2022/CHU/15
- Acronym
- HypnoDA
- Status last verified
- Sep 2026
- First submitted
- 3 Nov 2022
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers : Study Protocol of a Pilot Randomized and Controlled Trial
- ClinicalTrials.gov ID
- NCT05611346
- Acronym / sponsor ID
- HypnoDA / 2022/CHU/15
- Conditions
- Dermatitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic education program | No intervention | – |
| Therapeutic education program and Hypnosis | Experimental | Behavioral: Hypnosis |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypnosisThe 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 | Behavioural | Therapeutic education program and Hypnosis |
Primary outcome
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.
6 secondary outcomes
Assess patient compliance with self-hypnosis practice
Time frame: 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
Patient satisfaction
Time frame: At 1 month, 3 months, and 6 months after inclusion
Improvements to the hypnosis program
Time frame: At 6 months after inclusion
Effectiveness
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Derived from this study: PubMed 41857860Thysebaert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliette MIQUEL, MD principal investigator
CHU de la Réunion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis in people with Dermatitis, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asses the patient recruitment rate (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05611346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.