Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-29 @ 1:12 PM
Study NCT ID:
NCT06346132
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2024-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2024-03-12', 'studyFirstSubmitQcDate': '2024-03-28', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global pain intensity experienced during the procedure.', 'timeFrame': 'At the end of surgery', 'description': 'Global pain intensity experienced during the procedure evaluated with the Visual Analogue Scale (VAS).'}], 'secondaryOutcomes': [{'measure': 'Need for supplementary sedation and/or analgesia during the procedure.', 'timeFrame': 'At the end of surgery', 'description': 'The need for supplementary sedation and/or analgesia during the procedure will be recorded. The doses of the drugs will be recorded.'}, {'measure': 'Global anxiety intensity experienced during the procedure.', 'timeFrame': 'At the end of surgery', 'description': 'Global anxiety intensity experienced during the procedure evaluated with the Visual Analogue Scale (VAS).'}, {'measure': "Patient's comfort during the procedure assessed by the surgeon and cardiologist.", 'timeFrame': 'At the end of surgery', 'description': "Patient's comfort during the procedure assessed by the surgeon and cardiologist using the Numeric Rating Scale (NRS)."}, {'measure': 'Incidence of motion sickness during the virtual reality experience.', 'timeFrame': 'At patient discharge (or at a maximum of 4 hours after the end of surgery)', 'description': 'Incidence of motion sickness during the virtual reality experience (for example nausea)'}, {'measure': "Patient's perceived procedure duration.", 'timeFrame': 'At the end of surgery', 'description': "Patient's perceived procedure duration compared to effective procedure duration."}, {'measure': 'Maximal systolic arterial blood pressure.', 'timeFrame': 'At the end of surgery', 'description': 'Maximal systolic arterial blood pressure recorded during the procedure.'}, {'measure': 'Incidence of hypotensive or hypoxic events during procedure.', 'timeFrame': 'At the end of surgery', 'description': 'Incidence of hypotensive events (defined by systolic arterial blood pressure less than 90 mmhg) and/or hypoxic events (defined by oxygen saturation under 90%) during the procedure.'}, {'measure': 'Total dose of local anaesthetic used during the procedure.', 'timeFrame': 'At the end of surgery', 'description': 'Total dose of local anaesthetic used during the procedure (total dose in mg).'}, {'measure': 'Change in anesthetic strategy during procedure.', 'timeFrame': 'At the end of surgery', 'description': 'If a change of anesthesiologic strategy is needed during the procedure (for example, if the patient needs an unplanned general anesthesia during the procedure).'}, {'measure': 'Interruption of virtual reality experience during the procedure.', 'timeFrame': 'At the end of surgery', 'description': 'If the patient choose to remove the virtual reality headset and interrupt the virtual reality experience during the procedure.'}, {'measure': 'Intra- and post-procedure complications.', 'timeFrame': 'At patient discharge (or at a maximum of 4 hours after the end of surgery)', 'description': 'Registration of any complication during and after the procedure.'}, {'measure': "Overall patient's comfort and satisfaction experienced during the procedure.", 'timeFrame': 'At patient discharge (or at a maximum of 4 hours after the end of surgery)', 'description': "Overall patient's comfort and satisfaction experienced during the procedure assessed with Likert's scale (5 points)."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Virtual Reality', 'Medical Device', 'Local Anesthesia', 'Pain']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the effect on patient's comfort of a virtual reality experience during a procedure of cardiac electronic device implantation under local anesthesia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 year old,\n* Patients who signed the consent form and accepted to participate to the trial,\n* New cardiac electronic device implantation or cardiac electronic device battery change,\n* Surgical procedure planned in ambulatory care.\n\nExclusion Criteria:\n\n* Communication limitations,\n* Surgical procedure planned in sedation or narcosis,\n* Severe sensorial deficits (visual, auditory),\n* Claustrophobia,\n* Known motion sickness,\n* Patient isolated or with contact precautions,\n* Known or anticipated psychiatric diseases,\n* Patient known for epilepsia,\n* Opened scar and or ongoing infection at the level of the face and/or eyes,\n* Patient evaluated non suitable for the study by the surgeon, cardiologist or anesthetist.'}, 'identificationModule': {'nctId': 'NCT06346132', 'briefTitle': "Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.", 'organization': {'class': 'OTHER', 'fullName': 'Ente Ospedaliero Cantonale, Bellinzona'}, 'officialTitle': "Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation: a Randomized, Controlled Trial.", 'orgStudyIdInfo': {'id': '2024-00043 CE 4516'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'In this group, virtual reality will be added to usual care', 'interventionNames': ['Device: Virtual reality application']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Group', 'description': 'In this group, no extra intervention will be added to usual care'}], 'interventions': [{'name': 'Virtual reality application', 'type': 'DEVICE', 'description': 'In this group, virtual reality will be added to usual care', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6900', 'city': 'Lugano', 'state': 'Canton Ticino', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Herve Schlotterbeck, MD', 'role': 'CONTACT', 'email': 'herve.schlotterbeck@eoc.ch', 'phone': '+41918115189'}], 'facility': 'Istituto CardioCentro', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}], 'centralContacts': [{'name': 'Herve Schlotterbeck, MD', 'role': 'CONTACT', 'email': 'herve.schlotterbeck@eoc.ch', 'phone': '+41918115189'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schlotterbeck Hervé', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Schlotterbeck Hervé', 'investigatorAffiliation': 'Ente Ospedaliero Cantonale, Bellinzona'}}}}