Peripheral Arterial DiseaseREVDOUNCT07181434
Impact of Virtual Reality on Patient Pain During Lower Limb Revascularization Via Endovascular Surgery Under Local Anesthesia With Sedation
A study testing The patient will be equipped with VR headsets in people with Peripheral Arterial Disease, run by Poitiers University Hospital at 1 site in France.
Trial summary
The prevalence of peripheral arterial disease (PAD) increases with age In addition to medical treatment, endovascular procedures can be performed, depending on the stage of the disease, to prevent complications and/or sequelae (relapse, functional loss of the affected limb, amputation, death), but also to relieve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- The patient will be equipped with VR headsets
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2026to 3 Sep 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
- Patient suffering from PAD, scheduled to undergo endovascular surgery for lower limb revascularization under local anesthesia combined with sedation.
- Age ≥ 18 years.
- Patient who understands and speaks French.
- Patient covered by social security or covered through a third party.
- Free subject, without guardianship, curatorship, or subordination.
- Patient who has given their free and informed consent.
Who cannot join
- Patients with contraindications to VR headsets (mono- or binocular blindness, epilepsy, migraines, psychiatric disorders, pacemakers, hearing aids, defibrillators, recent injuries to the eyes, face, or scalp that prevent comfortable use of the headsets, etc.).
- Patients with suspected intolerance to VR headsets (sensitivity to motion sickness in cars, history of balance or eye disorders, etc.);
- Previous bad experience with VR headsets;
- Patients undergoing local regional anesthesia (LRA);
- Persons requiring enhanced protection, namely persons deprived of their liberty by judicial or administrative decision, pregnant women, and finally patients in life-threatening situations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
C.H.U. Poitiers
Poitiers, 86000
Amélie PETIT, +33 5 49 44 69 70, Amelie.PETIT@chu-poitiers.fr
About this study
Official title: Impact of Virtual Reality on Patient Pain During Lower Limb Revascularization Via Endovascular Surgery Under Local Anesthesia With Sedation - Randomized Study
The prevalence of peripheral arterial disease (PAD) increases with age In addition to medical treatment, endovascular procedures can be performed, depending on the stage of the disease, to prevent complications and/or sequelae (relapse, functional loss of the affected limb, amputation, death), but also to relieve pain. This is a minimally invasive procedure most often performed under local anesthesia (LA), sometimes with the administration of sedatives (morphine and analgesics) to relieve pain and reduce anxiety related to the procedure.
Non-pharmacological methods such as virtual reality (VR) are increasingly being used as an alternative to general anesthesia and excessive opioid use.
The hypothesis is that VR could reduce pain during lower limb revascularization by endovascular surgery.
Read the detailed description
The prevalence of peripheral arterial disease (PAD) increases with age. In high-income countries, it is 5% between the ages of 45 and 49, and 18% after the age of 85. In France, nearly 1 million people are affected by this disease.
In addition to medical treatment, endovascular procedures can be performed, depending on the stage of the disease, to prevent complications and/or sequelae (relapse, functional loss of the affected limb, amputation, death), but also to relieve pain. This is a minimally invasive procedure most often performed under local anesthesia (LA), sometimes with the administration of sedatives (morphine and analgesics) to relieve pain and reduce anxiety related to the procedure.
Local anesthesia causes discomfort related to the operating environment (low temperature, harsh lighting, noise, supine position, arms along the body, cold, hard, narrow table), impacting patient cooperation and making the procedure difficult, with the need to take multiple X-rays and reinject potentially nephrotoxic contrast agents. It can lead to the procedure being stopped, with serious consequences (postponement, persistent or even worsening pain, amputation, death).
Non-pharmacological methods such as virtual reality (VR) are increasingly being used as an alternative to general anesthesia and excessive opioid use.
It has proven effective in managing pain and anxiety during various medical, surgical, and endovascular procedures. Its high-quality graphics immerse the patient; hypnotic speech and relaxing elements capture the patient's attention; breathing exercises help manage stress; and relaxing music creates a soothing atmosphere. This support ensures greater mental and physical comfort by reducing pain and anxiety.
The hypothesis is that VR could reduce pain during lower limb revascularization by endovascular surgery.
- Conditions
- Peripheral Arterial Disease
- Being tested
- The patient will be equipped with VR headsets
- Keywords
- Virtual reality, pain management, virtual reality headset
- Medical subject headings
- Peripheral Arterial Disease, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The patient will be equipped with VR headsetsDevice
The patient will be equipped with VR headsets showing one of the six scenes from the HealthyMind® program in 3D, accompanied by hypnotic speech during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| In addition to the usual care, the patient will be equipped with VR headsets | Experimental | In addition to the usual care, the patient will be equipped with VR headsets showing one of the six scenes from the HealthyMind® program in 3D, accompanied by hypnotic speech during the procedure. Receives: Device: The patient will be equipped with VR headsets |
| The patient will receive the usual treatment under local anesthesia | No intervention | The patient will receive standard care under local anesthesia with an analgesic injection (paracetamol) +/- morphine sedation (remifentanil), according to the treatment protocol and tailored to the patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum level of pain experienced by the patient during the procedure
The maximum level of pain will be assessed at the the end of the procedure using a numerical rating scale ranging from 0 (no pain) to 10 (worst pain imaginable)
Measured: At the end of the revascularization procedure
Secondary outcomes (15)
The difference in anxiety measures assessed at baseline and just after the intervention
Anxiety will be measured at baseline and just after the intervention using a numerical rating scale ranging from 0 for "no anxiety" to 10 for "maximum imagined anxiety": a quick, easy-to-use scale that correlates strongly with Spielberger's STAI scale (Benotsch et al., 2000).
Measured: At Baseline and just after the intervention of lower limb revascularization through endovascular surgery
Systolic Blood Pressure (SBP) in mmHg
Measured: At Baseline before the procedure of lower limb revascularization through endovascular surgery, upon arrival in the operating room, then every 15 minutes until the end of the procedure.
Diastolic Blood Pressure (DBP) in mmHg
Measured: At Baseline before the procedure of lower limb revascularization through endovascular surgery, upon arrival in the operating room, then every 15 minutes until the end of the procedure.
Heart Rate (HR) in cycles/min
Measured: At Baseline before the procedure of lower limb revascularization through endovascular surgery, upon arrival in the operating room, then every 15 minutes until the end of the procedure.
Respiratory Rate (RR) in Breaths Per Minute (BPM)
Measured: At Baseline before the procedure of lower limb revascularization through endovascular surgery, upon arrival in the operating room, then every 15 minutes until the end of the procedure.
Cumulated doses of analgesics consumed during the procedure (in mL/kg)
Cumulated doses will be standardized in mL/kg in order to obtain comparable measures accros patients
Measured: During the revascularization procedure
The dose of X-ray radiation
Total dose of X-ray radiation absorbed by the patient (dose-area product, in mGy.cm²)
Measured: During the procedure of revascularization of the lower limbs by endovascular surgery
The total volume of contrast medium delivered during the procedure
Measured: During the procedure of revascularization of the lower limbs by endovascular surgery
The difference between the duration of the procedure as perceived by the patient and the actual duration of the procedure (in minutes)
Measured: At the end of the procedure of revascularization of the lower limbs by endovascular surgery
The success rate of the procedure
Proportion of procedures performed successfully (total revascularization of the artery)
Measured: At the end of the procedure of revascularization of the lower limbs by endovascular surgery
Proportion of patients who kept the virtual reality headsets on throughout the procedure
Outcome assessed for the experimental group only (with VR headset)
Measured: Throughout the procedure of lower limb revascularization through endovascular surgery
Satisfaction level of the virtual reality headset
Satisfaction will be measured with a numerical rating scale ranging from 0 (not satisfied at all) to 10 (completely satisfied). Outcome assessed for the experimental group only (with VR headset)
Measured: At the end of the procedure of lower limb revascularization through endovascular surgery
Comfort level experienced by the patient during the procedure
Comfort will be measured after the procedure using a numerical rating scale ranging from 0 (very uncomfortable) to 10 (very comfortable).
Measured: Comfort will be assessed at the end of the revascularization procedure
Cumulated doses of morphine derivatives consumed during the procedure (in mL/kg)
Cumulated doses will be standardized in mL/kg in order to obtain comparable measures accross patients
Measured: During the revascularization procedure
Cumulated doses of anesthetics consumed during the procedure (in mL/kg)
Cumulated doses will be standardized in mL/kg in order to obtain comparable measures accross patients
Measured: During the revascularization procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start3 Mar 2026
- Primary completion3 Sep 2027 (estimated)
- Study completion3 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Poitiers 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181434
- Sponsor's protocol ID
- REVDOU
- Acronym
- REVDOU
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Virtual Reality on Patient Pain During Lower Limb Revascularization Via Endovascular Surgery Under Local Anesthesia With Sedation - Randomized Study
- ClinicalTrials.gov ID
- NCT07181434
- Acronym / sponsor ID
- REVDOU / REVDOU
- Conditions
- Peripheral Arterial Disease
- Keywords
- Virtual reality, pain management, virtual reality headset
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 3 Sep 2027 (estimated)
- Study completion
- 3 Sep 2027 (estimated)
- First posted
- 18 Sep 2025 (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.
The prevalence of peripheral arterial disease (PAD) increases with age In addition to medical treatment, endovascular procedures can be performed, depending on the stage of the disease, to prevent complications and/or sequelae (relapse, functional loss of the affected limb, amputation, death), but also to relieve pain. This is a minimally invasive procedure most often performed under local anesthesia (LA), sometimes with the administration of sedatives (morphine and analgesics) to relieve pain and reduce anxiety related to the procedure.
Non-pharmacological methods such as virtual reality (VR) are increasingly being used as an alternative to general anesthesia and excessive opioid use.
The hypothesis is that VR could reduce pain during lower limb revascularization by endovascular surgery.
Detailed description
The prevalence of peripheral arterial disease (PAD) increases with age. In high-income countries, it is 5% between the ages of 45 and 49, and 18% after the age of 85. In France, nearly 1 million people are affected by this disease.
In addition to medical treatment, endovascular procedures can be performed, depending on the stage of the disease, to prevent complications and/or sequelae (relapse, functional loss of the affected limb, amputation, death), but also to relieve pain. This is a minimally invasive procedure most often performed under local anesthesia (LA), sometimes with the administration of sedatives (morphine and analgesics) to relieve pain and reduce anxiety related to the procedure.
Local anesthesia causes discomfort related to the operating environment (low temperature, harsh lighting, noise, supine position, arms along the body, cold, hard, narrow table), impacting patient cooperation and making the procedure difficult, with the need to take multiple X-rays and reinject potentially nephrotoxic contrast agents. It can lead to the procedure being stopped, with serious consequences (postponement, persistent or even worsening pain, amputation, death).
Non-pharmacological methods such as virtual reality (VR) are increasingly being used as an alternative to general anesthesia and excessive opioid use.
It has proven effective in managing pain and anxiety during various medical, surgical, and endovascular procedures. Its high-quality graphics immerse the patient; hypnotic speech and relaxing elements capture the patient's attention; breathing exercises help manage stress; and relaxing music creates a soothing atmosphere. This support ensures greater mental and physical comfort by reducing pain and anxiety.
The hypothesis is that VR could reduce pain during lower limb revascularization by endovascular surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In addition to the usual care, the patient will be equipped with VR headsets | Experimental | Device: The patient will be equipped with VR headsetsIn addition to the usual care, the patient will be equipped with VR headsets showing one of the six scenes from the HealthyMind® program in 3D, accompanied by hypnotic speech during the procedure. |
| The patient will receive the usual treatment under local anesthesia | No intervention | –The patient will receive standard care under local anesthesia with an analgesic injection (paracetamol) +/- morphine sedation (remifentanil), according to the treatment protocol and tailored to the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient suffering from PAD, scheduled to undergo endovascular surgery for lower limb revascularization under local anesthesia combined with sedation.
- Age ≥ 18 years.
- Patient who understands and speaks French.
- Patient covered by social security or covered through a third party.
- Free subject, without guardianship, curatorship, or subordination.
Key exclusion criteria (5 listed)
- Patients with contraindications to VR headsets (mono- or binocular blindness, epilepsy, migraines, psychiatric disorders, pacemakers, hearing aids, defibrillators, recent injuries to the eyes, face, or scalp that prevent comfortable use of the headsets, etc.).
- Patients with suspected intolerance to VR headsets (sensitivity to motion sickness in cars, history of balance or eye disorders, etc.);
- Previous bad experience with VR headsets;
- Patients undergoing local regional anesthesia (LRA);
- Persons requiring enhanced protection, namely persons deprived of their liberty by judicial or administrative decision, pregnant women, and finally patients in life-threatening situations.
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 |
|---|---|---|
| The patient will be equipped with VR headsetsThe patient will be equipped with VR headsets showing one of the six scenes from the HealthyMind® program in 3D, accompanied by hypnotic speech during the procedure. | Device | In addition to the usual care, the patient will be equipped with VR headsets |
Primary outcome
The maximum level of pain experienced by the patient during the procedure
Time frame: At the end of the revascularization procedure
The maximum level of pain will be assessed at the the end of the procedure using a numerical rating scale ranging from 0 (no pain) to 10 (worst pain imaginable)
15 secondary outcomes
The difference in anxiety measures assessed at baseline and just after the intervention
Time frame: At Baseline and just after the intervention of lower limb revascularization through endovascular surgery
Systolic Blood Pressure (SBP) in mmHg
Time frame: At Baseline before the procedure of lower limb revascularization through endovascular surgery, upon arrival in the operating room, then every 15 minutes until the end of the procedure.
Diastolic Blood Pressure (DBP) in mmHg
Time frame: At Baseline before the procedure of lower limb revascularization through endovascular surgery, upon arrival in the operating room, then every 15 minutes until the end of the procedure.
Heart Rate (HR) in cycles/min
Time frame: At Baseline before the procedure of lower limb revascularization through endovascular surgery, upon arrival in the operating room, then every 15 minutes until the end of the procedure.
Respiratory Rate (RR) in Breaths Per Minute (BPM)
Time frame: At Baseline before the procedure of lower limb revascularization through endovascular surgery, upon arrival in the operating room, then every 15 minutes until the end of the procedure.
Cumulated doses of analgesics consumed during the procedure (in mL/kg)
Time frame: During the revascularization procedure
The dose of X-ray radiation
Time frame: During the procedure of revascularization of the lower limbs by endovascular surgery
The total volume of contrast medium delivered during the procedure
Time frame: During the procedure of revascularization of the lower limbs by endovascular surgery
The difference between the duration of the procedure as perceived by the patient and the actual duration of the procedure (in minutes)
Time frame: At the end of the procedure of revascularization of the lower limbs by endovascular surgery
The success rate of the procedure
Time frame: At the end of the procedure of revascularization of the lower limbs by endovascular surgery
Proportion of patients who kept the virtual reality headsets on throughout the procedure
Time frame: Throughout the procedure of lower limb revascularization through endovascular surgery
Satisfaction level of the virtual reality headset
Time frame: At the end of the procedure of lower limb revascularization through endovascular surgery
Comfort level experienced by the patient during the procedure
Time frame: Comfort will be assessed at the end of the revascularization procedure
Cumulated doses of morphine derivatives consumed during the procedure (in mL/kg)
Time frame: During the revascularization procedure
Cumulated doses of anesthetics consumed during the procedure (in mL/kg)
Time frame: During the revascularization procedure
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 31 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The patient will be equipped with VR headsets in people with Peripheral Arterial Disease, run by Poitiers 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 5 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 31 Aug 2026. 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 Amélie PETIT (+33 5 49 44 69 70, Amelie.PETIT@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum level of pain experienced by the patient during the procedure (time frame: At the end of the revascularization procedure). 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 31 Aug 2026.