NCT05779852

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Jun 2023Apr 2027

First Submitted

Initial submission to the registry

March 10, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 29, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

May 21, 2025

Status Verified

June 1, 2024

Enrollment Period

3.3 years

First QC Date

March 10, 2023

Last Update Submit

May 20, 2025

Conditions

Vascular Surgical Procedures

Keywords

lower extremity artery diseaseself-hypnosisamputation care

Outcome Measures

Primary Outcomes (1)

  • Level of pain

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

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

Study Arms (2)

self-hypnosis and care

EXPERIMENTAL
Other: self-hypnosis and dressing

care

OTHER
Other: dressing

Interventions

self-hypnosis and dressingOTHER

self-hypnosis during dressing

self-hypnosis and care
dressingOTHER

dressing without self-hypnosis

care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years;
  • Naïve to amputation procedures;
  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Rennes

Rennes, France

RECRUITING

MeSH Terms

Interventions

HypnosisBandages

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesEquipment and Supplies

Study Officials

  • Claudie BOUFFORT

    CHU Rennes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Mevel

CONTACT

02 99 28 25 55dri@chu-rennes.fr

Anne Ganivet

CONTACT

02 99 28 25 55anne.ganivet@chu-rennes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2023

First Posted

March 22, 2023

Study Start

June 29, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

May 21, 2025

Record last verified: 2024-06

Locations

FR(1)