跳至主要内容
临床试验/NCT05611346
NCT05611346招募中不适用

HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers : Study Protocol of a Pilot Randomized and Controlled Trial

Centre Hospitalier Universitaire de la Réunion2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年8月13日最近更新:
适应症

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

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)

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验