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).

introductionAtopic dermatitis (AD) is a chronic inflammatory skin disease affecting up to 14% of the French children. Topical treatments are restrictive, leading patients to seek alternative options. Medical hypnosis may be a therapeutic approach, providing hypno-analgesia through comfort and soothing of the skin as well as anxiolysis by managing stress and boosting self-esteem. To date, only five studies have explored medical hypnosis in AD, showing promising results but limited by small sample sizes and lack of control arms. This study protocol describes the methodology for an initial evaluation of medical hypnosis within a therapeutic patient education (TPE) programme, called Hypno-DA. METHODS AND ANALYSIS: The Hypno-Atopic Dermatitis (Hypno-AD) study is a prospective, monocentric, non-blinded, parallel, cluster-randomised controlled trial conducted at the University Hospital of La Reunion, France. The study commenced on 13 August 2024 and is scheduled to conclude on 13 August 2026. The primary objective is to assess the feasibility of recruiting for a medical hypnosis programme for children with mild-to-severe AD. 32 patients (aged 8-17 years) will be randomly allocated in a 1:1 ratio to receive TPE sessions combined with medical hypnosis (experimental arm) or the usual TPE sessions performed for AD without medical hypnosis (control arm). The experimental arm will employ a hypnosis-based intervention, referred to as the 'superhero costume' technique. Reinforcement will be provided through the practice of self-hypnosis at home, guided by listening to an audio recording provided on a Universal Serial Bus (USB) key. Secondary outcomes will be assessed at 1-month, 3-month and 6-month post-randomisation. These will include compliance with the required practice of self-hypnosis at home, rate of loss of follow-ups, patient satisfaction, effectiveness of the hypnosis programme on the control of AD (ADCT) and severity of AD (Patient-Oriented SCORing Atopic Dermatitis) and the global impression parents may have concerning the changes in their child's AD. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Ile de France I Research and Institutional Ethics Committee (No. 2022-A01153-40). All methods were carried out in accordance with French law No. 2012-300 (5 March 2012) related to research involving humans as well as Good Clinical Practices (International Council for Harmonisation (ICH) version 4 of 9 November 2016, and the decision of 24 November 2006). Methods will conform to the Declaration of Helsinki. Informed oral consent from at least one legal guardian of each participant will be obtained in addition to oral consent from the child. Results will be published in an indexed peer-reviewed journal as well as presented and disseminated at scientific conferences. TRIAL REGISTRATION NUMBER: NCT05611346.