Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05779852

Pain Management of Amputation Wounds With AutoHypnosis

Led by Rennes University Hospital · Updated on 2025-05-21

44

Participants Needed

1

Research Sites

196 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Pain Management of Amputation Wounds With AutoHypnosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 63 18 years
  • Na�efve to amputation procedures
  • Amputated, within 24 hours prior to inclusion, one, more or all toes
  • Pain level on the Numerical Scale 63 3 during the first dressing
  • Affiliated to a social security scheme
  • Having signed a free, informed and written consent.
Not Eligible

You will not qualify if you...

  • 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).

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU Rennes

Rennes, France

Actively Recruiting

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Research Team

N

Nicolas Mevel

CONTACT

A

Anne Ganivet

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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