Pain Management of Amputation Wounds With AutoHypnosis (MODOUPAAH)

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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Surgical Procedures
• Intervention / Treatment: Other: self-hypnosis and dressing; Other: dressing

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas Mevel; Phone Number: 02 99 28 25 55; Email: dri@chu-rennes.fr
• Study Contact Backup: Name: Anne Ganivet; Phone Number: 02 99 28 25 55; Email: anne.ganivet@chu-rennes.fr

Study Locations

• France
  • Rennes, France
    • Recruiting
    • Chu Rennes
    • Contact: Claudie BOUFFORT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: self-hypnosis and care	Other: self-hypnosis and dressing; self-hypnosis during dressing
Other: care	Other: dressing; dressing without self-hypnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Claudie BOUFFORT, Chu Rennes

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: self-hypnosis; lower extremity artery disease; amputation care
• Other Study ID Numbers: 35RC20_8896_MODOUPAAH; 2022-A00638-35 (Other Identifier: N°ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No