Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 4:14 AM
Study NCT ID:
NCT07325695
Status:
COMPLETED
Last Update Posted:
2026-01-08
First Post:
2025-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Virtual Reality Glasses on Pain and Anxiety During Intrauterine Device Insertion in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two parallel groups wiil be compared: VR distraction during IUD insertion versus standard care control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-24', 'studyFirstSubmitDate': '2025-12-09', 'studyFirstSubmitQcDate': '2025-12-24', 'lastUpdatePostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain insensity during IUD insertion', 'timeFrame': 'İmmediately after the procedure', 'description': 'Pain severity will be measured immediately after the IUD insertion procedure using the Visual Analog Scale'}, {'measure': 'Pain catastrophizing(Pain Catastrophizing Scale, PCS)', 'timeFrame': 'İmmediately after the procedure', 'description': 'Pain catastrophizing will be assessed immediatel the IUD insertion procedure using the Pain Catastrophizing Scale(PCS;13 items). Higher scores indicate greater catastrophizing.'}, {'measure': 'State Anxiety level(STAI-S)', 'timeFrame': 'İmmediately after the procedure', 'description': 'State anxiety will be measured immediately after the procedure using the State-Trait Anxiety Inventory- State Subscale(STAI-S). Higher scores indicate greater anxiety.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['virtual reality', 'anxiety', 'pain management'], 'conditions': ['Pain', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of virtual reality glasses on pain perception and anxiety levels during intrauterine device insertion in women. Participants undergoing intrauterine device insertion will be randomly assigned to either a virtual reality invervention group or a standard care control group. Pain intensity and anxiety levels will be assessed during and after the procedure using validated measurement tools. The findings of this study may contribute to improving patient comfort during intrauterine device insertion.', 'detailedDescription': 'This randomized controlled study will be conducted among women scheduled for intrauterine device insertion. Eligible participants will be randomly allocated into two groups: a virtual reality intervention group and a control group receiving standard care. Participants in the intervention group will be use virtual reality glasses during the intrauterine device insertion procedure, while the control group will undergo the procedure without virtual reality. Pain intensity will be measured using a validated pain scale during and after the procedure. Anxiety levels will be assessed using a validated state anxiety measurement tool. Sociodemographic and clinical characteristics of participants will also be recorded. The study will be conducted in accordance with ethical principles, and informed consent will be obtained from all participants.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'This study is based on a female-specific reproductive health intervention(İntrauterine device placement', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Those aged 18-49\n* Those who understand and speak Turkish\n* Those without visual or hearing impairments\n* Women who agree to participate in the study\n* Those with adequate mental and emotional health\n* Those who will undergo a copper intrauterine device (IUD)\n\nExclusion Criteria:\n\n* Those outside the 18-49 age range\n* Those who do not speak Turkish\n* Those with visual, hearing, or speech impairments\n* Those with diagnosed psychiatric illnesses\n* Those taking psychiatric medications'}, 'identificationModule': {'nctId': 'NCT07325695', 'briefTitle': 'Effect of Virtual Reality Glasses on Pain and Anxiety During Intrauterine Device Insertion in Women', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'The Effect of Virtual Reality Glasses on Perceived Pain and State Anxiety Levels During Intrauterine Device Insertion: a Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'Ondokuz Mayıs Üniversitesi'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Group', 'description': 'Participants will wear a VR headset during IUD insertion for pain and anxiety distraction', 'interventionNames': ['Device: Virtual Reality Headset']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants will receive standard care during IUD insertion without VR intervention'}], 'interventions': [{'name': 'Virtual Reality Headset', 'type': 'DEVICE', 'description': 'A VR headset will be used to provide immersive distraction during intrauterine device insertion to reduce pain and anxiety', 'armGroupLabels': ['Virtual Reality Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Samsun', 'state': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Ondokuz Mayis University', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual participant data will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Serap Ozturk Altinayak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Serap Ozturk Altinayak', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}