Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 12:54 AM
Study NCT ID:
NCT07181434
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-18
First Post:
2025-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Virtual Reality on Patient Pain During Lower Limb Revascularization Via Endovascular Surgery Under Local Anesthesia With Sedation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2025-08-08', 'studyFirstSubmitQcDate': '2025-09-11', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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."', 'timeFrame': 'At the end of the revascularization procedure of the lower limbs by endovascular surgery'}], 'secondaryOutcomes': [{'measure': '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"', 'timeFrame': 'At Baseline and just after the intervention of lower limb revascularization through endovascular surgery', 'description': '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).'}, {'measure': 'Systolic Blood Pressure (SBP) in mmHg', 'timeFrame': '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.'}, {'measure': 'Diastolic Blood Pressure (DBP) in mmHg', 'timeFrame': '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.'}, {'measure': 'Heart Rate (HR) in cycles/min', 'timeFrame': '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.'}, {'measure': 'Respiratory Rate (RR) in Beats Per Minute (BPM)', 'timeFrame': '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.'}, {'measure': 'Total doses and classes of analgesics, morphine derivatives, and anesthetics consumed', 'timeFrame': 'During the procedure of lower limb revascularization through endovascular surgery'}, {'measure': 'The dose of X-ray radiation', 'timeFrame': 'During the procedure of revascularization of the lower limbs by endovascular surgery', 'description': 'Total dose of X-ray radiation absorbed by the patient (dose-area product, in mGy.cm²)'}, {'measure': 'The volume of contrast medium delivered', 'timeFrame': 'During the procedure of revascularization of the lower limbs by endovascular surgery'}, {'measure': 'The difference between the duration of the procedure as perceived by the patient and the actual duration of the procedure in minutes', 'timeFrame': 'At the end of the procedure of revascularization of the lower limbs by endovascular surgery'}, {'measure': 'The success rate of the procedure', 'timeFrame': 'At the end of the procedure of revascularization of the lower limbs by endovascular surgery', 'description': 'Proportion of procedures performed successfully (total revascularization of the artery)'}, {'measure': 'Proportion of patients who kept the virtual reality headsets on throughout the procedure', 'timeFrame': 'Throughout the procedure of lower limb revascularization through endovascular surgery'}, {'measure': 'VR satisfaction score, rated on a scale from 0 for "not at all satisfied" to 10 for "completely satisfied."', 'timeFrame': 'At the end of the procedure of lower limb revascularization through endovascular surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual reality', 'pain management', 'virtual reality headset'], 'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': '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.\n\nNon-pharmacological methods such as virtual reality (VR) are increasingly being used as an alternative to general anesthesia and excessive opioid use.\n\nThe hypothesis is that VR could reduce pain during lower limb revascularization by endovascular surgery.', 'detailedDescription': "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.\n\nIn 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.\n\nLocal 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).\n\nNon-pharmacological methods such as virtual reality (VR) are increasingly being used as an alternative to general anesthesia and excessive opioid use.\n\nIt 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.\n\nThe hypothesis is that VR could reduce pain during lower limb revascularization by endovascular surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient suffering from PAD, scheduled to undergo endovascular surgery for lower limb revascularization under local anesthesia combined with sedation.\n* Age ≥ 18 years.\n* Patient who understands and speaks French.\n* Patient covered by social security or covered through a third party.\n* Free subject, without guardianship, curatorship, or subordination.\n* Patient who has given their free and informed consent.\n\nExclusion Criteria:\n\n* 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.).\n* Patients with suspected intolerance to VR headsets (sensitivity to motion sickness in cars, history of balance or eye disorders, etc.);\n* Previous bad experience with VR headsets;\n* Patients undergoing local regional anesthesia (LRA);\n* Persons requiring enhanced protection, namely persons deprived of their liberty by judicial or administrative decision, pregnant women, and finally patients in life-threatening situations.'}, 'identificationModule': {'nctId': 'NCT07181434', 'acronym': 'REVDOU', 'briefTitle': 'Impact of Virtual Reality on Patient Pain During Lower Limb Revascularization Via Endovascular Surgery Under Local Anesthesia With Sedation', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Impact of Virtual Reality on Patient Pain During Lower Limb Revascularization Via Endovascular Surgery Under Local Anesthesia With Sedation - Randomized Study', 'orgStudyIdInfo': {'id': 'REVDOU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'In addition to the usual care, the patient will be equipped with VR headsets', 'description': '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.', 'interventionNames': ['Device: The patient will be equipped with VR headsets']}, {'type': 'NO_INTERVENTION', 'label': 'The patient will receive the usual treatment under local anesthesia', 'description': '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.'}], 'interventions': [{'name': 'The patient will be equipped with VR headsets', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['In addition to the usual care, the patient will be equipped with VR headsets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'contacts': [{'name': 'Amélie PETIT', 'role': 'CONTACT', 'email': 'Amelie.PETIT@chu-poitiers.fr', 'phone': '+33 5 49 44 69 70'}], 'facility': 'C.H.U. Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}], 'centralContacts': [{'name': 'Amélie PETIT', 'role': 'CONTACT', 'email': 'Amelie.PETIT@chu-poitiers.fr', 'phone': '+33 5 49 44 69 70'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}