Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-01-01 @ 12:59 AM
Study NCT ID:
NCT07014267
Status:
RECRUITING
Last Update Posted:
2025-07-29
First Post:
2025-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality for Mindfulness and Anxiety Reduction in Fertility Procedures
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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2025-03-20', 'studyFirstSubmitQcDate': '2025-06-09', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in anxiety level before and after the intervention', 'timeFrame': '10 minutes before the procedure and 10 minutes after procedure (intervention group and control group)', 'description': 'Measured using the State-Trait Anxiety Inventory (STAI), which provides a score from 20 to 80. Higher scores indicate more anxiety. Change from baseline to post-procedure will be compared between VR and control groups. Score on STAI (range 20-80)'}], 'secondaryOutcomes': [{'measure': 'Visual Facial Anxiety Scale Score', 'timeFrame': '10 minutes before the procedure and 10 minutes after procedure (intervention group and control group)', 'description': 'A 6-tier visual facial anxiety scale used to assess preoperative anxiety. Scores range from 1 (most anxious) to 6 (least anxious). Will be used as an alternative assessment alongside STAI. Visual scale score (1-6)'}, {'measure': 'Pain Score', 'timeFrame': 'Immediately post-procedure', 'description': 'Pain levels will be assessed using a 10-point Numeric Rating Scale (NRS). Higher scores indicate greater pain. NRS score (0-10)'}, {'measure': 'Amount of Pain Medication Used', 'timeFrame': 'During and immediately after procedure', 'description': 'Total amount of analgesics or anesthetics administered, based on patient record and clinical protocol (measured in mg)'}, {'measure': 'Recovery Time', 'timeFrame': '30 minutes after the end of procedure (before discharge).', 'description': 'Measured in minutes to determine the duration of post-operative recovery.'}, {'measure': 'Composite Patient Satisfaction Score', 'timeFrame': '30 minutes after the end of procedure (before discharge).', 'description': '10-item emoji-based questionnaire scored from 1-5 or 1-3 per item, depending on the scale used. Total composite score ranges from 10-50 or 10-30. Higher scores indicate greater satisfaction. May be normalized to 0-100%. Unites of measure: Composite score (10-50) or percentage (0-100%)'}, {'measure': 'Recovery Time', 'timeFrame': '30 minutes after the end of procedure (before discharge).', 'description': 'Duration of patient recovery (minutes)'}, {'measure': 'Gender-specific Effectiveness', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Subgroup analysis of anxiety reduction by gender (male vs. female). Measured using the State-Trait Anxiety Inventory (STAI), which provides a score from 20 to 80. Higher scores indicate more anxiety. Change from baseline to post-procedure will be compared between VR and control groups. Score on STAI (range 20-80)'}, {'measure': 'Procedure-specific Effectiveness', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Subgroup analysis of primary outcome by procedure type. Measured using the State-Trait Anxiety Inventory (STAI), which provides a score from 20 to 80. Higher scores indicate more anxiety. Change from baseline to post-procedure will be compared between VR and control groups. Score on STAI (range 20-80). Difference in mean STAI score change by procedure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anxiety', 'stress', 'pain perception', 'recovery duration', 'virtual reality'], 'conditions': ['Virtual Reality', 'Patient Experience']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effectiveness of a Virtual Reality (VR)-based mindfulness and meditation intervention in reducing anxiety among patients undergoing fertility-related surgical procedures. Anxiety is a common challenge in fertility treatments, often leading to emotional distress and increased pain perception. By incorporating a non-invasive VR intervention, the investigators seek to improve patient experience, minimize preoperative anxiety, and potentially reduce postoperative discomfort and recovery times. This randomized controlled trial (RCT) will compare standard care with a VR intervention in a clinical setting, measuring key outcomes such as anxiety levels, pain perception, recovery duration, and overall patient satisfaction. The findings may contribute to more patient centered fertility care, offering an innovative, scalable, and cost-effective approach to anxiety management in reproductive medicine.', 'detailedDescription': 'This study examines the effectiveness of a Virtual Reality (VR) mindfulness intervention in reducing anxiety for patients undergoing fertility surgeries. The trial will compare VR with standard care, measuring outcomes like anxiety, pain, recovery time, and patient satisfaction. The results could provide a cost-effective, patient-centered approach to managing anxiety in fertility treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18-50.\n* Scheduled for fertility-related surgical procedures.\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* History of motion sickness or VR-related discomfort.\n* Cognitive or psychological conditions affecting participation.\n* Procedures requiring emergency intervention.'}, 'identificationModule': {'nctId': 'NCT07014267', 'briefTitle': 'Virtual Reality for Mindfulness and Anxiety Reduction in Fertility Procedures', 'organization': {'class': 'OTHER', 'fullName': 'ART Fertility Clinics LLC'}, 'officialTitle': 'Virtual Reality for Mindfulness and Anxiety Reduction in Fertility Procedures', 'orgStudyIdInfo': {'id': '2503-ABU-007-LMV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group (No VR intervention)', 'description': 'Patients will receive standard care without the VR intervention. Anxiety levels will be measured using the State-Trait Anxiety Inventory (STAI) before the procedure (baseline) and after the procedure.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group (Virtual Reality Intervention)', 'description': 'Patients will experience the VR mindfulness intervention using the Tripp App or comparable applications.\n\nAnxiety levels will be measured using the STAI before the VR experience, immediately after the VR experience, and after the procedure.', 'interventionNames': ['Device: Intervention Group (Virtual Reality intervention)']}], 'interventions': [{'name': 'Intervention Group (Virtual Reality intervention)', 'type': 'DEVICE', 'description': 'Patients will experience the VR mindfulness intervention using the Tripp App or comparable applications.\n\nAnxiety levels will be measured using the STAI before the VR experience, immediately after the VR experience, and after the procedure.', 'armGroupLabels': ['Intervention Group (Virtual Reality Intervention)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abu Dhabi', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'name': 'Jonalyn, Research Coordinator', 'role': 'CONTACT', 'email': 'jonalyn.edades@artfertilityclinics.com', 'phone': '+97126528000'}, {'name': 'Barbara Lawrenz, Research Director', 'role': 'CONTACT', 'email': 'barbara.lawrenz@artfertilityclinics.com', 'phone': '+97126528000'}, {'name': 'Laura Melado, Medical Director', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ART Fertility Clinics LLC', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'centralContacts': [{'name': 'Jonalyn Edades, Research Coordinator', 'role': 'CONTACT', 'email': 'jonalyn.edades@artfertilityclinics.com', 'phone': '+97126528000'}, {'name': 'Barbara Lawrenz, Research Director', 'role': 'CONTACT', 'email': 'barbara.lawrenz@artfertilityclinics.com', 'phone': '+97126528000'}], 'overallOfficials': [{'name': 'Barbara Lawrenz, Research Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ART Fertility Clinics LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ART Fertility Clinics LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director - Abu Dhabi', 'investigatorFullName': 'Laura Melado', 'investigatorAffiliation': 'ART Fertility Clinics LLC'}}}}