HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers
ConditionDermatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-17
SponsorCentre Hospitalier Universitaire de la Réunion
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Hypnosis
BehavioralThe 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
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Therapeutic education programNo intervention 0 interventions
Group B: Therapeutic education program and HypnosisExperimental treatment 1 intervention
Trial outcomes
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 monthsSecondary 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 inclusion2
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 inclusion3
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 inclusion4
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 inclusionSponsors and contacts
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Source ClinicalTrials.gov