Vascular Surgical ProceduresMODOUPAAHNCT05779852
Pain Management of Amputation Wounds With AutoHypnosis
A study testing self-hypnosis and dressing and dressing in people with Vascular Surgical Procedures, run by Rennes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Surgical Procedures
- What is being tested?
- self-hypnosis and dressing and dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2023to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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...)
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Conditions
- Vascular Surgical Procedures
- Being tested
- self-hypnosis and dressing, dressing
- Keywords
- lower extremity artery disease, self-hypnosis, amputation care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-hypnosis and dressingOther
self-hypnosis during dressing
dressingOther
dressing without self-hypnosis
| Study group | Role | What they receive |
|---|---|---|
| self-hypnosis and care | Experimental | Not described Receives: Other: self-hypnosis and dressing |
| care | Other | Not described Receives: Other: dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of pain
pain self-assessment numerical scale graduated from "0" - no pain - to "10" - unimaginable pain.
Measured: Day 2 (during the 3rd post-operative amputation bandage)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start29 Jun 2023
- Primary completionOct 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudie BOUFFORT, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779852
- Sponsor's protocol ID
- 35RC20_8896_MODOUPAAH
- Other IDs
- 2022-A00638-35
- Acronym
- MODOUPAAH
- Status last verified
- Jun 2024
- First submitted
- 10 Mar 2023
- Last updated
- 21 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management of Amputation Wounds With AutoHypnosis
- ClinicalTrials.gov ID
- NCT05779852
- Acronym / sponsor ID
- MODOUPAAH / 35RC20_8896_MODOUPAAH
- Conditions
- Vascular Surgical Procedures
- Keywords
- lower extremity artery disease, self-hypnosis, amputation care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| self-hypnosis and care | Experimental | Other: self-hypnosis and dressing |
| care | Other | Other: dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-hypnosis and dressingself-hypnosis during dressing | Other | self-hypnosis and care |
| dressingdressing without self-hypnosis | Other | care |
Primary outcome
Level of pain
Time frame: Day 2 (during the 3rd post-operative amputation bandage)
pain self-assessment numerical scale graduated from "0" - no pain - to "10" - unimaginable pain.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudie BOUFFORT principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-hypnosis and dressing and dressing in people with Vascular Surgical Procedures, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Mevel (02 99 28 25 55, dri@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of pain (time frame: Day 2 (during the 3rd post-operative amputation bandage)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.