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NCT Number: NCT05779852

Pain Management of Amputation Wounds With AutoHypnosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Rennes

Rennes, France

Location status: Recruiting

Location contact

Claudie BOUFFORT

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

self-hypnosis and dressing

Other

self-hypnosis during dressing

dressing

Other

dressing without self-hypnosis

Primary outcomes

  1. Level of pain

    Time frame: Day 2 (during the 3rd post-operative amputation bandage)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Ganivet

CONTACT

[email protected]

02 99 28 25 55

Nicolas Mevel

CONTACT

[email protected]

02 99 28 25 55

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: MODOUPAAH

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Mar 22, 2023
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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