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Pain Management of Amputation Wounds With AutoHypnosis

Pain Management of Amputation Wounds With AutoHypnosis

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05779852
Acronym
MODOUPAAH
Enrollment
44
Registered
2023-03-22
Start date
2023-06-29
Completion date
2027-04-30
Last updated
2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Surgical Procedures

Keywords

lower extremity artery disease, self-hypnosis, amputation care

Brief summary

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.

Interventions

OTHERself-hypnosis and dressing

self-hypnosis during dressing

dressing without self-hypnosis

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Level of painDay 2 (during the 3rd post-operative amputation bandage)pain self-assessment numerical scale graduated from 0 - no pain - to 10 - unimaginable pain.

Countries

France

Contacts

Primary ContactNicolas Mevel
dri@chu-rennes.fr02 99 28 25 55
Backup ContactAnne Ganivet
anne.ganivet@chu-rennes.fr02 99 28 25 55

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026