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临床试验/NCT04372537
NCT04372537已完成不适用

Medical Hypnosis Against Anxiety and Pain in Electro-neuro-myography

University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2021年3月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6
试验地点
2
主要终点
Pain score evaluated by analogue visual scale

研究概览

简要总结

Electroneuromyography (ENMG) is a regular neurological investigation that might be painful or unpleasant. Medical hypnosis can avoid these sensations, and is more and more performed during other medico-technical procedures (radiology, biopsies for example). This study aims at evaluate the effect of medical hypnosis on pain and anxiety during ENMG, in patients presenting with anxiety. Our hypothesis is that the anxiety and pain during ENMG will be lower in patients with hypnosis compared to patients with standard care. This will allow us to help patients with this tool during most ENMG procedures, and extend it to other electrophysiological procedures in the future.

详细描述

Medical hypnosis is more and more used during some medico-technical investigational procedures, such as interventional radiology, dental procedures, baby deliveries. Using the modified conscious state induced by trance or by conversational hypnosis (thanks to verbal and nonverbal language) allows a better tolerance of these procedures. Only very few situations recommend against this approach.

ENMG is a frequently performed procedure in neurology to explore neuromuscular functions. It implies electric stimulations, needle insertion and needs the patient cooperation and the patient's well-being. This is all the more necessary that this procedure may be repeated for a patient along his/her life.

Only one study evaluated the effect of hypnosis on pain and anxiety during ENMG (Slack and al., 2009). Despite a low statistical power due to a small sample, it showed a reduction of the maximal pain during the needle electromyography.

More proof is therefore needed to assess the efficacity of hypnosis against pain and anxiety during ENMG.

Several members of our nurse and medical team have an experience in hypnosis practice and this procedure is sometimes used in some patients, when specifically required, alone or with other analgesic procedures (like nitrous oxide), but not in the current standard practice. This is mainly useful in patients with anxiety.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient admitted for ENMG manifesting: spontaneous verbal anxiety about taking the test/- a state of anxiety about the examination, as evidenced by a dark colour on a wellness scale used in the unit
  • with a good understanding of the French language
  • able to complete self-questionnaires
  • Patient who has given written consent to participate in the trial
  • Socially insured patient

排除标准

  • algesic sensitivity disorders
  • known history of psychiatric illness or current known psychiatric illness: severe depression, psychosis
  • Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security coverage, refusal to sign the consent form

结局指标

主要结局

Pain score evaluated by analogue visual scale

时间窗: at the end of electro-neuro-myography exam

EVA measures the intensity of pain on a scale of 0 (no pain) to 10 (maximum pain imaginable)

次要结局

  • Anxiety score evaluated by analogue visual scale(at the end of electro-neuro-myography exam)
  • anxiety score evolution evaluated by analogue visual scale(between baseline and at the end of electro-neuro-myography exam)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (2)

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