Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT06393556
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2024-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VR for the Reduction of Perioperative Anxiety
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': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Care provider measuring the primary outcome scale at T2 was not aware of the intervention given at T0/1. Statistical data analysis initially was prepared not knowing which group was the intervention group.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 randomization'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2024-04-26', 'studyFirstSubmitQcDate': '2024-04-30', 'lastUpdatePostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety', 'timeFrame': 'T0 (before randomization), T1 (same day as T0, but after care as usual +/- VR; usually inside 1 hour), T2 (days/weeks later, before surgical procedure - exact gap is unknown; expected: >3 days, median around 4-7 weeks)', 'description': 'Anxiety level measured by a 6-item visual scale (1 .. least anxiety, 6 ... highest anxiety)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anxiety', 'virtual reality', 'gynecologic-oncological surgery'], 'conditions': ['Anxiety State']}, 'referencesModule': {'references': [{'pmid': '28196099', 'type': 'BACKGROUND', 'citation': 'Cao X, Yumul R, Elvir Lazo OL, Friedman J, Durra O, Zhang X, White PF. A novel visual facial anxiety scale for assessing preoperative anxiety. PLoS One. 2017 Feb 14;12(2):e0171233. doi: 10.1371/journal.pone.0171233. eCollection 2017.'}, {'pmid': '38791991', 'type': 'RESULT', 'citation': 'Schmid BC, Marsland D, Jacobs E, Rezniczek GA. A Preparatory Virtual Reality Experience Reduces Anxiety before Surgery in Gynecologic Oncology Patients: A Randomized Controlled Trial. Cancers (Basel). 2024 May 17;16(10):1913. doi: 10.3390/cancers16101913.'}]}, 'descriptionModule': {'briefSummary': 'The study, set to take place at Gold Coast University Hospital in Australia, will be conducted as a randomized controlled trial. Patients preparing for gynecological cancer surgery will be recruited and randomly assigned to one of two groups: those who will receive standard care plus a virtual reality (VR) intervention, and those who will receive only standard care. Standard care encompasses the usual pre-operative procedures and support provided by the hospital staff.\n\nWe hypothesize that immersing patients in a preparatory virtual environment that shows them what they are to expect during their upcoming hospital stay for surgery, could help reduce their anxiety levels.', 'detailedDescription': 'The study objective is to determine whether exposure to the operating theatre suite via virtual reality (VR) for patients undergoing gynecologic-oncological surgery reduces pre-operative anxiety.\n\nAfter patients are recruited, their anxiety level is measured by a simple 6-item visual anxiety scale (T0). Patients are then randomized into either receiving care-as-usual (CAU), or CAU combined with a VR experience (\\~3.5 minutes; with background music and narration) where they are familiarized with the environment they will encounter during their stay for their cancer operation. Anxiety is measured again (T1). Days/weeks later, when patients are back in the hospital for their surgery (T2), anxiety is measured again in the preanesthetic bay, before receiving any anesthetics. Personnel collecting the anxiety scale at T2 will be unaware whether a patient had received the VR intervention or not.\n\nRandomization will be performed by a person unrelated to the study by using a computerized randomization tool to generate an allocation list and inserting paper slips with the group allocation into consecutively numbered, opaque envelopes which are opened, in order, at the time of randomization.\n\nUsing a two-sided Wilcoxon-Mann-Whitney test and targeting a power of 80% at a significance level α of 0.05, abd assuming a clinically relevant difference in the anxiety scale of at least one "face" (i.e. at least 1 point on the 6-item scale) between the two groups and a within-group standard deviation of 1.6 (effect size: 0.625), sample size was determined as 34 patients per group for a 1:1 group allocation. Assuming a drop out/lost-to-follow up rate of up to 15%, 80 patients (40 per group) are to be recruited.\n\nDescriptive statistic analysis will be performed. Within-group and between-group assessements will be done using Wilcoxon signed rank test and the Mann-Whitney rank sum test, respectively.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gynecological oncology patients with scheduled surgery\n\nExclusion Criteria:\n\n* Language barrier\n* Inability to provide consent\n* Having undergone any procedure at the operating theatre in the previous 5 years'}, 'identificationModule': {'nctId': 'NCT06393556', 'briefTitle': 'VR for the Reduction of Perioperative Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Ruhr University of Bochum'}, 'officialTitle': 'Assessment and Minimization of Preoperative Fear of the Unknown Using a VR Experience of the Theatre Suite; a Randomized Control Trial', 'orgStudyIdInfo': {'id': 'VRPERIOP1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual reality', 'description': 'Care-as-usual + virtual reality intervention during a pre-operative visit', 'interventionNames': ['Other: Virtual reality experience']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Care-as-usual during a pre-operative visit'}], 'interventions': [{'name': 'Virtual reality experience', 'type': 'OTHER', 'description': 'An immersive VR experience, delivered using a VR head-mounted display, of the real-world environment at the hospital, featuring the pre-operative admission suite, pre-anesthetic bay, operating theatre, postoperative recovery room, and medical staff.', 'armGroupLabels': ['Virtual reality']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4215', 'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Gold Coast University Hospital', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}], 'overallOfficials': [{'name': 'Bernd C Schmid, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gold Coast University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'After publication', 'ipdSharing': 'YES', 'description': 'De-identified data will be shared upon reasonable request for purposes that have been approved by the respective Institutional Review Board', 'accessCriteria': 'Reasonable request; approval of intended use by an Institutional Review Board'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruhr University of Bochum', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gold Coast Hospital and Health Service', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Ob/Gyn Research Lab (MHH)', 'investigatorFullName': 'Günther Rezniczek', 'investigatorAffiliation': 'Ruhr University of Bochum'}}}}