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临床试验/NCT02844348
NCT02844348撤回不适用

Impact of Hypnosis on the Management of Chronic and Breakthrough Pain of Chronic Dialysis Patients Suffering From Arterial Disease

University Hospital, Grenoble1 个研究点 分布在 1 个国家开始时间: 2016年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Evaluation of pain intensity when hypnosis is applied during dialysis

研究概览

简要总结

A chronic renal disease can results in the development of cardiovascular complications, including chronic arterial disease ; but a cardiovascular disease may be from a kidney malfunction that will end in end stage renal disease (ESRD). Two thirds of the chronic hemodialysis patients taken in charge in Grenoble in the last years suffered from an arterial disease at a symptomatic stage. Breakthrough pain can appear during the hemodialysis sessions. These sessions induce sudden hemodynamic changes and a peripheral vasoconstriction reaction that increases in particular all pain phenomena related to chronic low limbs ischemia. Therefore, patients have to face pain, sometimes chronic but also breakthrough pain, during the dialysis sessions, in all its dimensions.

The analgesic balance through the classical drug treatment is extremely complex, as they are both at risk of overdose and of partial effectiveness. Strict medical treatment remains unsatisfactory, as it takes into account only the expressions of symptoms during dialysis sessions, when most of the time pain is already installed and analgesic treatment is not completely effective.

The combination of classic pharmacological treatment with hypnosis, already used in other indications (chronic pain, analgesia, depression and anxiety), may mitigate the painful feeling on patients suffering from arterial disease during the dialysis sessions, with a beneficial impact on their overall quality of life. There is also evidence to suggest that hypnosis may be more effective treating neuropathic or vascular pain, those experienced by our patients, than musculoskeletal pain, like back pain.

Hypnosis is a mind-body approach focused on the subject, and not on the disease or the act of dialysis. It can be described at the same time as a modified state of consciousness and a particular intersubjective relation between a practitioner and his patient. The practice of this kind of hypnoanalgesia by the nurses is particularly relevant in hemodialysis, as the trust developed during regular chronic treatment can become an asset to shorten the induction phase and help to install this intersubjective relation.

The high incidence of this complication, the difficulties of current pain management and the impact on everyday life for the patients, justify the choice of this approach, where more further research is needed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
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
否

入选标准

  • •Chronic hemodialysis patients, requiring dialysis at least 3 times per week.
  • •Patients rating pain on a Visual analogue scale (VAS) > or = to 3 during hemodialysis sessions for lower limb pain related to chronic arterial disease.
  • •Patients affiliated to a health insurance company.
  • •Patients having consented to participate in the study.

排除标准

  • •Patients protected by law (under guardianship, deprived of liberty ...).
  • •Pregnant women.
  • •Patients not understanding French.
  • •Patients with cognitive, psychotic or behavioral disorders.
  • •Patients with a hearing loss limiting communication.

研究组 & 干预措施

Standard pain control

No Intervention

Classical pain assessment and drug treatment at each dialysis session.

Hypnosis

Experimental

Besides the classical pain assessment and drug treatment, hypnosis sessions during 2 periods of one week of dialysis sessions.

干预措施: Hypnosis session (Other)

结局指标

主要结局

Evaluation of pain intensity when hypnosis is applied during dialysis

时间窗: up to 60 sec

Pain is evaluate with a scale : Visual Analogue Pain Scale (VAPS) according to patients impression.

次要结局

未报告次要终点

研究者

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

研究点 (1)

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