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Clinical Trial NCT07181434 (REVDOU) for Peripheral Arterial Disease is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Impact of Virtual Reality on Patient Pain During Lower Limb Revascularization Via Endovascular Surgery Under Local Anesthesia With Sedation (REVDOU) 90 Virtual
Clinical Trial NCT07181434 (REVDOU) is an interventional study for Peripheral Arterial Disease and is currently not yet recruiting. Enrollment is planned to begin on 15 October 2025 and continue until the study accrues 90 participants. Led by Poitiers University Hospital, this study is expected to complete by 15 April 2027. The latest data from ClinicalTrials.gov was last updated on 18 September 2025.
Brief 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 pain. This is a minimally invasive procedure most often performed under local anesthesia (LA), sometimes ...Show More
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 th...
Show MoreOfficial Title
Impact of Virtual Reality on Patient Pain During Lower Limb Revascularization Via Endovascular Surgery Under Local Anesthesia With Sedation - Randomized Study
Conditions
Peripheral Arterial DiseaseOther Study IDs
- REVDOU
NCT ID Number
Start Date (Actual)
2025-10-15
Last Update Posted
2025-09-18
Completion Date (Estimated)
2027-04-15
Enrollment (Estimated)
90
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Virtual reality
pain management
virtual reality headset
pain management
virtual reality headset
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalIn addition to the usual care, the patient will be equipped with VR headsets 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. | The patient will be equipped with VR headsets 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. |
No InterventionThe patient will receive the usual treatment under local anesthesia 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. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
The maximum intensity of pain experienced by the patient during the procedure will be measured at the end of the procedure using the numerical pain scale (EN) ranging from 0 for "no pain" to 10 for "worst pain imaginable." | At the end of the revascularization procedure of the lower limbs by endovascular surgery |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Anxiety will be measured at Baseline and just after the intervention using an EN ranging from 0 for "no anxiety" to 10 for "maximum imagined anxiety" | Anxiety will be measured at Baseline and just after the intervention using an EN 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). | At Baseline and just after the intervention of lower limb revascularization through endovascular surgery |
Systolic Blood Pressure (SBP) in mmHg | 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 | 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 | 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 Beats Per Minute (BPM) | 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. | |
Total doses and classes of analgesics, morphine derivatives, and anesthetics consumed | During the procedure of lower limb revascularization through endovascular surgery | |
The dose of X-ray radiation | Total dose of X-ray radiation absorbed by the patient (dose-area product, in mGy.cm²) | During the procedure of revascularization of the lower limbs by endovascular surgery |
The volume of contrast medium delivered | 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 | 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) | 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 | Throughout the procedure of lower limb revascularization through endovascular surgery | |
VR satisfaction score, rated on a scale from 0 for "not at all satisfied" to 10 for "completely satisfied." | At the end of the procedure of lower limb revascularization through endovascular surgery |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
Poitiers University HospitalStudy Central Contact
Contact: Amélie PETIT, +33 5 49 44 69 70, [email protected]
1 Study Locations in 1 Countries
C.H.U. Poitiers, Poitiers, 86000, France
Amélie PETIT, Contact, +33 5 49 44 69 70, [email protected]