Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-29 @ 7:38 PM
Study NCT ID:
NCT07068594
Status:
COMPLETED
Last Update Posted:
2025-07-20
First Post:
2025-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Application of Virtual Reality Goggles During the First Wound Dressing After Open Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2025-07-07', 'studyFirstSubmitQcDate': '2025-07-07', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Severity', 'timeFrame': 'Immediately before the dressing procedure and 10 minutes after the procedure', 'description': 'Pain intensity will be assessed using the Visual Analog Scale (VAS). It is a 10 cm scale ranging from 0 (no pain) to 10 (worst possible pain). Measurements were taken before the dressing procedure and 10 minutes after the procedure.'}], 'secondaryOutcomes': [{'measure': 'Anxiety level', 'timeFrame': 'Immediately before the dressing procedure and 10 minutes after the procedure', 'description': 'Anxiety will be measured using the State-Trait Anxiety Inventory (STAI). The inventory consist of 20 items rated on a 4 point Likert scale ranging from 1 (not at all), to 4 (very much so). The state anxiety subscale will be pre and post intervention to evaluate changes in situational anxiety levels.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['virtual reality', 'pain', 'anxiety', 'heart surgery', 'wound dressing', 'vital signs', 'nursing', 'intensive care unit nursing', 'surgical nursing'], 'conditions': ['Pain Management', 'Wound Care', 'Heart Surgery', 'Heart Surgery Via Sternotomy', 'Dressing']}, 'descriptionModule': {'briefSummary': "The aim of this study is to examine the effect of virtual reality glasses, a non-pharmacological method used in pain and anxiety management in nursing practices, on the pain, anxiety, and vital parameters perceived by patients undergoing their first dressing change after open heart surgery. Additionally, the study aims to obtain information about the safety of the virtual reality application. The primary questions this study seeks to answer are as follows:\n\nDoes the virtual reality headset application reduce the pain participants feel during the procedure?\n\nDoes the application reduce participants' anxiety levels during the procedure?\n\nDoes the virtual reality application have a positive effect on vital signs (pulse, blood pressure, etc.)?\n\nDo participants experience any side effects or medical problems during this application?\n\nResearchers will compare the group that received virtual reality glasses during the first dressing change after open-heart surgery with the standard care (control group) to evaluate the effects of the intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals who verbally or in writing agree to participate in the study,\n* Are over 18 years of age,\n* Have not been diagnosed with any psychiatric disorder and are not using psychiatric medication,\n* Have no visual, auditory, or perceptual impairments,\n* Are undergoing their first wound dressing change following open-heart surgery,\n\nExclusion Criteria:\n\n* Patients who are unconscious,\n* Individuals who have undergone two or more wound dressing changes after open-heart surgery,\n* Patients who report pain due to any other condition,'}, 'identificationModule': {'nctId': 'NCT07068594', 'briefTitle': 'The Application of Virtual Reality Goggles During the First Wound Dressing After Open Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'The Effect of Virtual Reality Application on Pain, Anxiety, and Vital Parameters During the First Dressing Change After Open Heart Surgery', 'orgStudyIdInfo': {'id': 'OHSFP2025-01'}, 'secondaryIdInfos': [{'id': 'NoSecondaryID01', 'type': 'OTHER', 'domain': 'NoSecondaryID01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Glasses During the First Dressing Change Usage', 'description': 'In this group, virtual reality glasses were used during the procedure for individuals who would have their first dressing changed on the first postoperative day after open heart surgery.', 'interventionNames': ['Device: Virtual Reality Goggles']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Dressing Procedure without VR', 'description': 'A standard dressing change procedure was performed on this group.'}], 'interventions': [{'name': 'Virtual Reality Goggles', 'type': 'DEVICE', 'description': 'A device consisting of glasses placed on the head of patients in the intervention group and earphones attached to the glasses', 'armGroupLabels': ['Virtual Reality Glasses During the First Dressing Change Usage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09100', 'city': 'Aydin', 'state': 'Merkez', 'country': 'Turkey (Türkiye)', 'facility': 'Aydin Adnan Menderes University - Institute of Health Sciences', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aydin Adnan Menderes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RN, MSc - Specialist Nurse in Surgical Nursing, Department of Surgical Diseases Nursing, Adnan Menderes University', 'investigatorFullName': 'Almira Gurcan', 'investigatorAffiliation': 'Aydin Adnan Menderes University'}}}}