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临床试验/NCT05779852
NCT05779852招募中不适用

Pain Management of Amputation Wounds With AutoHypnosis

Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年6月29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
44
试验地点
1
主要终点
Level of pain

研究概览

简要总结

Amputation in vascular surgery mainly concerns the lower limb and is often linked to Obliterative Arterial Disease of the Lower Limbs. It indicates the impossibility or failure of revascularisation after an exhaustive assessment aimed at saving the limb. It is also performed to limit the spread of gangrene, an affection of the limb that can evolve into septicaemia. The principle is to amputate in a healthy and vascularised area to allow good healing of the amputation stump.

Amputations of one, several or all toes, called complete transmetatarsal amputations, may take several months to heal. Amputations require directed healing and, above all, monitoring of the underlying tissues of the amputated area by daily detersions and wiping performed by a nurse at home. The mechanical detersion of the wound necessary for the healing process and cell migration, as well as optimal deep meshing, facilitate the evolution of the healing process.

These treatments often cause pain, despite oral analgesics and local anaesthetics prior to the treatment.

For several years, studies have shown the benefits of hypnosis in modifying the perception of pain, particularly during treatment.

Studies have also shown that self-hypnosis allows a reduction in the intensity of pain.

The clinical experience of the vascular surgery department of the University Hospital of Rennes suggests that patients who use self-hypnosis during the daily dressing of their amputation experience the moment more serenely, increasing their comfort and decreasing their pain and anxiety.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

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

  • Age ≥ 18 years;
  • Naïve to amputation procedures;
  • Amputated, within 24 hours prior to inclusion, one, more or all toes
  • Pain level on the Numerical Scale ≥ 3 during the first dressing;
  • Affiliated to a social security scheme;
  • Having signed a free, informed and written consent.

排除标准

  • Cognitive impairments that limit understanding of instructions;
  • Cultural limitations reducing abstraction skills;
  • Previous practice of hypnosis;
  • Contraindications to hypnosis: Bipolar disorder or decompensated schizophrenia;
  • Chronic non-vascular pain;
  • Already in care for painful chronic wounds (ulcer wounds, bedsores...)
  • On morphine before surgery;
  • Analgesia by perineural catheter;
  • Protected person (adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty, pregnant woman (declarative), nursing woman and minor).

结局指标

主要结局

Level of pain

时间窗: Day 2 (during the 3rd post-operative amputation bandage)

pain self-assessment numerical scale graduated from "0" - no pain - to "10" - unimaginable pain.

次要结局

未报告次要终点

研究者

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

研究点 (1)

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