HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers : Study Protocol of a Pilot Randomized and Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Asses the patient recruitment rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Asses the patient recruitment rate
时间窗: 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.
次要结局
- Assess patient compliance with self-hypnosis practice(At 1 month, 3 months, and 6 months after inclusion)
- Patient satisfaction(At 1 month, 3 months, and 6 months after inclusion)
- Improvements to the hypnosis program(At 6 months after inclusion)
- Parents' overall impression(At 1 month, 3 months, and 6 months after enrollment)
- Patient lost sight of(At 1 month, 3 months, and 6 months after inclusion)
- Effectiveness(At 1 month, 3 months, and 6 months after inclusion)