Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT05183269
Status:
COMPLETED
Last Update Posted:
2022-01-10
First Post:
2021-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Virtual Reality for Pain Control During Extracorporeal Shock Wave Lithotripsy: a Prospective, Comparative, Randomized Study at a Single Institution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}, {'id': 'D053039', 'term': 'Ureterolithiasis'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014515', 'term': 'Ureteral 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Control arm: diclofenac 100 mg suppository + local lidocain/prilocain cream (EMLA 5g, Aspen) Intervention arm: diclofenac 100 mg suppository + local lidocain/prilocain cream (EMLA 5g, Aspen) + Oncomfort virtual reality monitor'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-21', 'studyFirstSubmitDate': '2021-12-21', 'studyFirstSubmitQcDate': '2021-12-21', 'lastUpdatePostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain levels', 'timeFrame': 'right after the procedure', 'description': 'Pain levels determined by a VAS-score'}], 'secondaryOutcomes': [{'measure': 'Satisfaction levels', 'timeFrame': 'right after the procedure', 'description': 'Satisfaction levels determined by a LIKERT-scale'}, {'measure': 'Total delivered energy', 'timeFrame': 'right after the procedure', 'description': 'The total delivered energy during the shock-wave lithotripsy'}, {'measure': 'Clinical success', 'timeFrame': '2 weeks after the procedure', 'description': 'We defined clinical success as stone-free patients or patients with asymptomatic residual fragments ≤ 4 mm after 1 or more ESWL-sessions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality', 'Shock-wave Lithotripsy', 'Pain control'], 'conditions': ['Stone, Kidney', 'Stone Ureter']}, 'referencesModule': {'references': [{'pmid': '36680576', 'type': 'DERIVED', 'citation': "Weynants L, Chys B, D'hulst P, Merckx L, Van Besien J, Tailly T. Virtual reality for pain control during shock wave lithotripsy: a randomized controlled study. World J Urol. 2023 Feb;41(2):589-594. doi: 10.1007/s00345-023-04280-8. Epub 2023 Jan 21."}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to prospectively analyze patient satisfaction, pain, delivered energy and clinical effectiveness of using VR as a complimentary treatment modality during SWL.', 'detailedDescription': 'The patients were randomized in two groups SWL with VR and SWL without VR. When a patient was randomized for a VR session we put on the monitor after adequate patient positioning. We used the Oncomfort Sedakit.\n\nThe size and location of stone pre-treatment was measured based on the best available imaging tool (CT\\>RX/ultrasonography) using the maximal stone diameter. The locations of the stones were described as upper pole stones, midpolar stones, lower pole stones, renal pelvis stones and proximal ureteric stones. Each SWL treatment was standardized using diclofenac 100 mg suppository as analgesic and local lidocain/prilocain cream (EMLA 5g, Aspen) to numb the skin. Visualization of the stone was done by fluoroscopy of ultrasonography, as these proved to be equivalent (Van Besien et al. 2017).\n\nA specific and standardized ramping protocol was applied. After finishing this protocol, the energy level could be raised further depending on the level of discomfort of the patient.\n\nDirectly after the procedure, the patients were asked to complete a questionnaire where they were asked to write down the experienced amount of pain during the procedure on a VAS of 10 cm and the satisfaction level using a Likert-scale. The total delivered energy was noted.\n\nTwo weeks after every SWL session, follow-up imaging (ultrasound and plain abdominal radiography) was performed by a radiologist. Residual stone size was estimated on plain abdominal radiography or ultrasonography. The radiologist was blinded for the randomization process. Practitioner and patient were not. After each SWL the clinical outcome was noted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients with renal or ureteric stones in need of a shock-wave lithotripsy. The indication was based on the European association of urology guidelines\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05183269', 'briefTitle': 'Virtual Reality for Pain Control During Extracorporeal Shock Wave Lithotripsy: a Prospective, Comparative, Randomized Study at a Single Institution', 'organization': {'class': 'OTHER', 'fullName': 'AZ Sint-Lucas Gent'}, 'officialTitle': 'Virtual Reality for Pain Control During Extracorporeal Shock Wave Lithotripsy: a Prospective, Comparative, Randomized Study at a Single Institution', 'orgStudyIdInfo': {'id': '2018-44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual reality', 'description': 'Normal procedure with the use of a virtual reality monitor', 'interventionNames': ['Device: Oncomfort virtual reality monitor (Oncomfort SA, Wavre, Belgium)']}, {'type': 'NO_INTERVENTION', 'label': 'no virtual reality', 'description': 'Normal procedure without the use of a virtual reality monitor'}], 'interventions': [{'name': 'Oncomfort virtual reality monitor (Oncomfort SA, Wavre, Belgium)', 'type': 'DEVICE', 'description': 'Use of the Oncomfort virtual reality monitor', 'armGroupLabels': ['Virtual reality']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'Oost-Vlaanderen', 'country': 'Belgium', 'facility': 'AZ Sint-Lucas', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AZ Sint-Lucas Gent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'docter', 'investigatorFullName': 'Luc Merckx', 'investigatorAffiliation': 'AZ Sint-Lucas Gent'}}}}