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临床试验/NCT04829578
NCT04829578已完成不适用

A Prospective Study of Hypnosis for Chronic Idiopathic Pruritus

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年4月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Change From Baseline in Pruritus Numeric Rating Scale

研究概览

简要总结

Chronic idiopathic pruritus (CIP) is a frequent and disabling condition, for which there is no specific treatment. It was shown previously that hypnosis can relieve painful sensations. Pain and pruritus share many similarities regarding sensory receptors and pathways, suggesting that hypnosis might help relief CIP.

详细描述

Chronic idiopathic pruritus (CIP) is a frequent and disabling condition, with significative impact on quality of life. At present, there is no specific treatment for CIP. Topical steroids are frequently used, with partial efficacy, and adverse effects. Hypnosis is a specific state of conscience. It differs from waking state, sleeping state, relaxation, or meditation. In this state, the person is highly responsive to suggestion. In medicine, hypnosis can be used to engage the internal resources of the person against unpleasant feelings. It was shown previously that hypnosis can relieve painful sensations. Pain and pruritus share many similarities regarding sensory receptors and pathways, suggesting that hypnosis might help relief CIP.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female of at least 18 years at screening
  • Diagnosis of chronic (at least 6 wks.) idiopathic pruritus
  • Pruritus Numeric Rating Scale > = 4

排除标准

  • Pruritus caused by a dermatological or a systemic conditions
  • Suicidal crisis, moderate, or severe
  • Psychosis (schizophrenia, persistent delusional disorder)
  • Bipolar disorder, not stabilized or decompensating
  • Personality disorder, decompensated

结局指标

主要结局

Change From Baseline in Pruritus Numeric Rating Scale

时间窗: Day 84

Assessment of the intensity of pruritis in Pruritus Numeric Rating Scal; the minimum and maximum values 0 to 10

次要结局

  • Change From Baseline in Pruritus Verbal Rating Scale(Day 84)
  • Change From Baseline in DLQI scale(Day 84)
  • Change From Baseline in HAD scale(Day 84)
  • Change From Baseline in usage of topical steroids(Day 84)
  • Change From Baseline in Sleeping Scale(Day 84)
  • Evaluation of tolerance of hypnosis(Day 84)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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