Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-02-24 @ 2:31 PM
Study NCT ID:
NCT07039812
Status:
RECRUITING
Last Update Posted:
2025-06-26
First Post:
2025-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Virtual Reality and Eye Mask During Dressing After CABG Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomly assigned to one of three parallel arms: VR intervention, eye mask intervention, or standard care control.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2025-06-03', 'studyFirstSubmitQcDate': '2025-06-25', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Analgesic Use Frequency', 'timeFrame': 'Baseline and immediately after first and second dressing', 'description': 'Analgesic agents administered in the intensive care unit, including their names, routes of administration, dosages, and timing, will be systematically documented.'}], 'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'Baseline, immediately after, and 15 minutes after first and second dressing', 'description': 'Pain intensity will be measured using the Visual Analog Scale (VAS) at three time points: before, immediately after, and 15 minutes after both the first and second sternotomy dressing procedures.'}, {'measure': 'State-Trait Anxiety Inventory (STAI-II)', 'timeFrame': 'Baseline, immediately after, and 15 minutes after first and second dressing', 'description': 'State anxiety levels (STAI-I) will be measured before, immediately after, and 15 minutes after both the first and second dressing procedures. Trait anxiety (STAI-II) will be measured only once, before surgery.'}], 'secondaryOutcomes': [{'measure': 'Physiological Parameters (Blood pressure)', 'timeFrame': 'Baseline, during, immediately after, and 15 minutes after first and second dressing', 'description': 'Blood pressure will be monitored using a monitor device.'}, {'measure': 'Physiological Parameters (Pulse)', 'timeFrame': 'Baseline, during, immediately after, and 15 minutes after first and second dressing', 'description': 'Pulse will be monitored using a monitoring device.'}, {'measure': 'Physiological Parameters (SpO₂)', 'timeFrame': 'Baseline, during, immediately after, and 15 minutes after first and second dressing', 'description': 'Saturation values will be monitored using a monitoring device.'}, {'measure': 'Physiological Parameters (Respiratory rate )', 'timeFrame': 'Baseline, during, immediately after, and 15 minutes after first and second dressing', 'description': 'Respiratory rate will be monitored using a monitoring device.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Artery Bypass Graft', 'Virtual Reality', 'Eye Mask', 'Pain Management', 'Anxiety', 'Physiological Parameter'], 'conditions': ['CABG', 'Physiological Parameter', 'Postoperative Pain', 'Postoperative Anxiety', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effects of virtual reality (VR) and eye mask (EM) applications on pain, anxiety, and physiological parameters during dressing after Coronary Artery Bypass Graft (CABG) surgery.\n\nPostoperative dressing procedures, especially after sternotomy, often cause significant pain and anxiety in patients. These issues can negatively impact recovery and increase the need for medication. Non-pharmacological interventions such as VR and EM may help reduce these symptoms.\n\nIn this randomized controlled trial, 90 patients are divided into three groups: VR group, EM group, and a control group receiving standard care. Pain and anxiety levels are monitored baseline, immediately after, and 15 minutes after both the first and second dressing procedures. Physiological parameters are measured baseline, during, immediately after, and 15 minutes after both dressing procedures. Additionally, analgesic use is followed baseline and immediately after each dressing procedure. The study is conducted in a cardiovascular intensive care unit in Istanbul, Türkiye. It is expected that the findings will support the integration of VR and EM as effective, low-cost, and non-invasive options for postoperative care, improving patient comfort and healthcare quality.', 'detailedDescription': 'This randomized controlled experimental study investigates the effects of virtual reality (VR) and eye mask (EM) applications on sternotomy pain, anxiety, and physiological parameters during postoperative dressing following Coronary Artery Bypass Graft (CABG) surgery.Pain and anxiety during dressing procedures after CABG surgery can negatively affect the recovery process, increase stress responses, prolong hospital stays, and raise the need for medication. Non-pharmacological interventions such as VR and EM are considered effective strategies for managing these symptoms.\n\nThe study includes 90 patients, randomly assigned to one of three groups: VR Group: Patients watched 360-degree nature-themed videos using a virtual reality headset during dressing. EM Group: Patients wore an eye mask during dressing. Control Group: Patients received standard care without any additional intervention. The study is being conducted in the Cardiovascular Surgery Intensive Care Unit of a public hospital located in Istanbul, Türkiye.\n\nInclusion criteria include adult patients undergoing CABG for the first time, ASA classification I-II-III, fully conscious, oriented, cooperative, and willing to provide informed consent. Exclusion criteria include patients with infections or complications, psychiatric disorders, or sensory impairments such as hearing or vision problems. Pain and anxiety levels are assessed at three time points during both the first and second dressing procedures: baseline, immediately after dressing, and 15 minutes after dressing. Physiological parameters (blood pressure, pulse rate, respiratory rate, oxygen saturation) are measured at four time points: baseline, immediately after dressing, and 15 minutes after dressing. Analgesic use is recorded baseline and immediately after each dressing. This study is one of the first to compare VR and EM interventions in the context of high-risk, postoperative cardiac surgery. The results are expected to contribute to evidence-based nursing practices, improve patient comfort in the postoperative period, and support the use of cost-effective, drug-free alternatives for pain and anxiety management in clinical care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-65 years\n* First-time coronary artery bypass graft (CABG) surgery for coronary artery disease\n* ASA physical status I, II, or III\n* Conscious, oriented, and cooperative\n* Able to communicate verbally\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Presence of sternal wound infection or inflammation\n* Intubated at the time of assessment\n* Undergoing revision surgery\n* Receiving anesthesia or sedation in the ICU\n* Experiencing intraoperative or postoperative complications\n* Inability to speak Turkish\n* Hearing or visual impairment\n* Diagnosed psychiatric or cognitive disorder\n* Diagnosis of epilepsy\n* Body mass index (BMI) ≥ 30\n* Participation in another clinical trial during the same period'}, 'identificationModule': {'nctId': 'NCT07039812', 'acronym': 'CABG', 'briefTitle': 'The Effect of Virtual Reality and Eye Mask During Dressing After CABG Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'The Effect of Virtual Reality and Eye Mask Application During Dressing After Coronary Artery Bypass Graft Surgery on Sternotomy Pain, Anxiety, and Physiological Parameters', 'orgStudyIdInfo': {'id': 'CABG-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Group', 'description': 'Participants in this group will watch 360-degree nature-themed videos through a virtual reality headset (Oculus meta quest 2) during both the first and second sternotomy dressing procedures.', 'interventionNames': ['Device: Virtual Reality Headset']}, {'type': 'EXPERIMENTAL', 'label': 'Eye Mask Group', 'description': 'Participants in this group will wear an eye mask during both the first and second sternotomy dressing procedures.', 'interventionNames': ['Device: Eye Mask']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants in this group will receive standard postoperative care during dressing, with no additional interventions applied.'}], 'interventions': [{'name': 'Virtual Reality Headset', 'type': 'DEVICE', 'description': 'During the dressing change, nature-themed videos will be shown through a virtual reality headset that immerses the user in a 360-degree, three-dimensional virtual environment.', 'armGroupLabels': ['Virtual Reality Group']}, {'name': 'Eye Mask', 'type': 'DEVICE', 'description': 'A soft, adjustable, 3D-structured eye mask (Poblex brand) will be applied during the dressing procedure.', 'armGroupLabels': ['Eye Mask Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Marmara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Tuğçe Bozkurt Elmas, PhD(c)', 'role': 'CONTACT', 'email': 'tugce.bozkurt10@ogr.iuc.edu.tr', 'phone': '905063137927'}, {'name': 'Ayfer Özbaş, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tuğçe Bozkurt Elmas, PhD (c)', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Öykü Kara, PhD (c)', 'role': 'SUB_INVESTIGATOR'}, {'name': 'İsmail Haberal, Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Müge Sezek, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Prof. Dr. Cemil Taşçıoğlu City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Tuğçe Bozkurt Elmas, PhD (c)', 'role': 'CONTACT', 'email': 'tugce.bozkurt10@ogr.iuc.edu.tr', 'phone': '905063137927'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate', 'investigatorFullName': 'Tugce Bozkurt Elmas', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}