Pain Management of Amputation Wounds With AutoHypnosis

Vascular Surgical Procedures Clinical Trial

— MODOUPAAH  

Official title:

Pain Management of Amputation Wounds With AutoHypnosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05779852
• Other study ID #: 35RC20_8896_MODOUPAAH
• Secondary ID: 2022-A00638-35
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2023
• Est. completion date: April 2025

Study information

• Verified date: June 2024
• Source: Rennes University Hospital
• Contact: Nicolas Mevel
• Phone: 02 99 28 25 55
• Email: dri[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: April 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Vascular Surgical Procedures

Intervention

Other:
• self-hypnosis and dressing
self-hypnosis during dressing
• dressing
dressing without self-hypnosis

Locations

Country	Name	City	State
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)