MODOUPAAH: Pain Management of Amputation Wounds With AutoHypnosis

Sponsor
Rennes University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05779852
Collaborator
(none)
44
2
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: self-hypnosis and dressing
  • Other: dressing
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Pain Management of Amputation Wounds With AutoHypnosis
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Level of pain [Day 2 (during the 3rd post-operative amputation bandage)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Rennes University Hospital

Investigators

  • Principal Investigator: Claudie BOUFFORT, CHU Rennes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT05779852
Other Study ID Numbers:
  • 35RC20_8896_MODOUPAAH
  • 2022-A00638-35
First Posted:
Mar 22, 2023
Last Update Posted:
Mar 22, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rennes University Hospital

Study Results

No Results Posted as of Mar 22, 2023