Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT06215456
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2023-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Virtual Reality to Reduce Periprocedural Anxiety During Invasive Coronary Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-10', 'studyFirstSubmitDate': '2023-12-19', 'studyFirstSubmitQcDate': '2024-01-18', 'lastUpdatePostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NRS anxiety', 'timeFrame': 'Assessed at established moment right before start op procedure.', 'description': 'Numeric rating score for anxiety with 0 representing no anxiety and 10 the worst anxiety imaginable.'}], 'secondaryOutcomes': [{'measure': 'NRS anxiety', 'timeFrame': 'At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure', 'description': 'Numeric rating score for anxiety with 0 representing no anxiety and 10 the worst anxiety'}, {'measure': 'heart rate', 'timeFrame': 'At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure'}, {'measure': 'blood pressure', 'timeFrame': 'At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure', 'description': 'Both systolic and diastolic blood pressure will be measured'}, {'measure': 'heart rate variability', 'timeFrame': 'At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure', 'description': 'LF/HF ratio are extracted'}, {'measure': 'heart rate variability', 'timeFrame': 'At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure', 'description': 'RMSSD (root mean square of the successive differences) is extracted'}, {'measure': 'heart rate variability', 'timeFrame': 'At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure', 'description': 'SDNN (standard deviation of the NN (R-R) intervals) is extracted'}, {'measure': 'respiration rate', 'timeFrame': 'At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure'}, {'measure': 'STAI-state short form', 'timeFrame': 'At t0 baseline and t5 10min after end of procedure', 'description': 'State-Trait Anxiety Inventory - state section - 6 item. Score range 6-24. Higher score is higher anxiety.'}, {'measure': 'STAI-trait', 'timeFrame': 'At t0 baseline', 'description': 'State-Trait Anxiety Inventory - trait section - 20 item. Score range 20-80. Higher score is higher anxiety.'}, {'measure': 'Perceived stress questionnaire', 'timeFrame': 'At t0 baseline', 'description': 'The PSS gives an indication about the feelings and thoughts during the past month of the patient. Score range 0-40. Higher score means higher perceived stress.'}, {'measure': 'Pain during arterial punction', 'timeFrame': 'At t4 during procedure (directly after arterial access)', 'description': 'Measured using NRS score, with 0 representing no pain and 10 worst pain imaginable'}, {'measure': 'Patient satisfaction', 'timeFrame': 'At t5 10min after end of procedure', 'description': 'Measured using NRS score, with 0 completely dissatisfied and 10 completely satisfied'}, {'measure': 'Cardiologist satisfaction with procedure', 'timeFrame': 'At t5 10min after end of procedure', 'description': 'Measured using NRS score, with 0 completely dissatisfied and 10 completely satisfied'}, {'measure': 'Radial artery spasm yes/no', 'timeFrame': 'At t5 10min after end of procedure', 'description': 'As reported by cardiologist'}, {'measure': 'complexity of procedure', 'timeFrame': 'At t5 10min after end of procedure', 'description': 'Reported by cardiologist in categories: less complex than anticipated - as anticipated - more complex than anticipated.'}, {'measure': 'anxiolytics use', 'timeFrame': 'At t2 20 minutes after t1 right before patients transfers to procedure room and t5 10min after end of procedure', 'description': 'Use of benzodiazepines (yes/no) was registered for each patient'}, {'measure': 'Igroup presence questionnaire', 'timeFrame': 't5 10min after end of procedure', 'description': 'Assesses the presence in the virtual environment, only taken in intervention group.'}, {'measure': 'Total finished VR sessions', 'timeFrame': 't5 10min after end of procedure', 'description': 'Only taken in intervention group.'}, {'measure': 'Total duration of VR use', 'timeFrame': 't5 10min after end of procedure', 'description': 'Only taken in intervention group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual reality therapy', 'Procedural anxiety', 'Invasive coronary angiography', 'nonpharmacological', 'Anxiolysis'], 'conditions': ['Anxiety', 'Anxiety State']}, 'referencesModule': {'references': [{'pmid': '38569670', 'type': 'DERIVED', 'citation': 'Breunissen EHW, Groenveld TD, Garms L, Bonnes JL, van Goor H, Damman P. Virtual reality to reduce periprocedural anxiety during invasive coronary angiography: rationale and design of the VR InCard trial. Open Heart. 2024 Apr 2;11(1):e002628. doi: 10.1136/openhrt-2024-002628.'}]}, 'descriptionModule': {'briefSummary': 'Introduction Patients undergoing invasive coronary angiography experience anxiety due to various factors. This can lead to physiological and psychological complications, compromising patient comfort and overall procedural outcomes. Benzodiazepines are commonly used to reduce periprocedural anxiety, although the effect is modest. VR is an promising nonpharmacological intervention that can be used to reduce anxiety in patients undergoing an invasive coronary angiography.\n\nMethods and analysis A single-center open-label randomized controlled trial was performed to assess the effectiveness of add-on VR therapy on anxiety in 100 patients undergoing invasive coronary angiography and experiencing anxiety in periprocedural setting. The primary outcome is the NRS anxiety score measured just before obtaining arterial access. Secondary outcomes are physiological measures of anxiety and the State-Trait Anxiety Inventory, Perceived Stress Scale, and IGroup presence questionnaire. The NRS anxiety level and physiological measurements will be taken at five scheduled times between pre procedural, peri and post procedural. The State-Trait Anxiety Inventory and Perceived Stress Scale will be performed prior to coronary angiography and the State-Trait Anxiety Inventory (state form) and the IGroup Presence questionnaire will be performed post-intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient ≥16 years undergoing elective cardiac catheterisation\n* Patient is willing and able to comply with the study protocol\n* NRS anxiety score ≥ 4\n\nExclusion Criteria:\n\n* History of dementia\n* Severe hearing/visual impairment not corrected\n* Depression or anxiety disorder'}, 'identificationModule': {'nctId': 'NCT06215456', 'acronym': 'VR InCard', 'briefTitle': 'Virtual Reality to Reduce Periprocedural Anxiety During Invasive Coronary Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Virtual Reality to Reduce Periprocedural Anxiety During Invasive Coronary Angiography: Rationale and Design of the VR InCard Trial', 'orgStudyIdInfo': {'id': '114869'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control group will be treated according to local protocol. Unless contra-indicated, patients experiencing moderate to severe anxiety before undergoing ICA may receive preprocedural oxazepam (10 mg, oral) at the day care unit and diazepam (5 mg, intravenous) before arterial puncture at the catheterization room at nurses and physicians discretion. In patients planned for coronary function testing, benzodiazepines are withheld per protocol.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Virtual Reality therapy', 'description': 'The VR intervention group will receive two sessions of VRH in addition to standard care. Before starting the first guided session in this study, patients can use VR during the waiting time using SyncVR Relax \\& Distract (SyncVR Medical, Utrecht, The Netherlands). Subsequently, the first session of VRH is administered at the day-care unit 20 minutes prior to the procedure. After the first session patients is transported to the catheterization room, where the treatment team have the possibility to introduce themselves to the patients. The second session of VRH is administered during arterial access puncture in the catheterization room, starting 5 minutes prior to puncture and terminating when the diagnostic or guiding coronary catheter is in position. The rest of the procedure will be continued without VR.', 'interventionNames': ['Device: Virtual reality therapy']}], 'interventions': [{'name': 'Virtual reality therapy', 'type': 'DEVICE', 'description': "VR therapy will be applied using a head mounted display, the PICO G2 4K headset (Barcelona, Spain). For VRD de application'SyncVR Relax \\& Distract' (SyncVR Medical, Utrecht, The Netherlands) will be used. This application contains a wide range of relaxation games, relaxing 360 videos, and relaxation exercises each with a duration of 5-20 minutes. Patients can choose videos, games, or exercises according to their own preferences. For VRH sessions, the application HypnoVR (Strasbourg, France) will be used. This app contains several hypnotic narratives integrating sequences of controlled breathing, cardiac coherence, and hypnotic suggestions. Each VRH sessions can be personalized through selecting different environments and musical compositions.The first VRH session will be set to last 20 minutes and the second VRH session will be set to the continuous setting.", 'armGroupLabels': ['Virtual Reality therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6525 GA', 'city': 'Nijmegen', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Groenveld, MD', 'role': 'CONTACT', 'email': 'tjitske.groenveld@radboudumc.nl'}], 'facility': 'Radboud university medical center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'Data will be provided upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}