Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT06906120
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-18
First Post:
2025-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Operating Room Introduction With Virtual Reality Glasses on Anxiety, Surgical Fear, and Satisfaction Levels in Patients Undergoing Orthopedic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2025-03-25', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain level: Measured using the Numeric Rating Scale (NRS)', 'timeFrame': 'Pain levels will be recorded within the first 2 hours after surgery using the NRS.', 'description': 'This measure will compare the postoperative pain levels between the virtual reality education and standard education groups. Pain level will be assessed using the Numerical Rating Scale (NRS).\n\nMinimum Value: 0 (No Pain) Maximum Value: 10 (Worst Pain) Higher Scores: Indicate worse outcomes, meaning more severe pain.'}, {'measure': 'Physiological parameters: Measured using electrodermal activity (EDA), heart rate, blood pressure (systolic and diastolic), respiratory rate, and peripheral oxygen saturation (SpO2).', 'timeFrame': 'Before the intervention, immediately after the intervention, 20 minutes before the transfer to the operating room on the morning of surgery, and 15 minutes after arriving at the inpatient ward.', 'description': 'This measure will assess the physiological responses (electrodermal activity, heart rate, blood pressure, respiratory rate, and SpO2) in patients after virtual reality education and standard education'}, {'measure': 'Satisfaction', 'timeFrame': 'Satisfaction will be measured within 2 hours after discharge procedures have started.', 'description': 'Patient satisfaction will be assessed using a satisfaction scale. Satisfaction with the intervention will be assessed using the Satisfaction Scale.\n\nMinimum Value: 1 (Very Dissatisfied) Maximum Value: 10 (Very Satisfied) Higher Scores: Indicate better outcomes, meaning higher satisfaction levels.'}], 'primaryOutcomes': [{'measure': 'Preoperative anxiety level: State-Trait Anxiety Inventory - STAI', 'timeFrame': 'STAI trait:1 day before surgery, prior to intervention/education STAI state:1.Immediately after STAI-II measurement 2.Immediately after the intervention/education 3.On the day of surgery, prior to premedication 4.Within 2 hours after surgery', 'description': "State-Trait Anxiety Inventory (STAI-I and STAI-II): This inventory measures individuals' current (state) anxiety levels and general (trait) anxiety tendencies. Both forms consist of 20 items and use a 4-point Likert-type response scale.\n\nScore range: Varies between 20 and 80. Higher scores: Indicate higher anxiety levels. Lower scores: Indicate lower anxiety levels."}], 'secondaryOutcomes': [{'measure': 'Surgical fear level: Measured using the Surgical Fear Scale', 'timeFrame': '1. Immediately after STAI-I measurement, 2. Immediately after the intervention/education, 3.On the day of surgery, prior to premedication', 'description': 'The change in surgical fear levels in the intervention and control groups will be assessed. Surgical Fear Scale (SFS); scores range from 0 to 100, with higher scores indicating greater fear.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['virtual reality illustration', 'Orthopedic surgery', 'Virtual reality', 'Surgical anxiety', 'Surgical fear', 'Preoperative education', 'Patient satisfaction', 'Pain management', 'Physiological parameters', 'Surgical preparation', 'VR intervention', 'Pain assessment', 'Electrodermal activity', 'Patient education tools', 'Preoperative anxiety reduction'], 'conditions': ['Artroscopic Surgery', 'Orthopedic Surgery']}, 'referencesModule': {'references': [{'pmid': '36319521', 'type': 'BACKGROUND', 'citation': 'Ugras GA, Kanat C, Yaman Z, Yilmaz M, Turkmenoglu MO. The Effects of Virtual Reality on Preoperative Anxiety in Patients Undergoing Colorectal and Abdominal Wall Surgery: A Randomized Controlled Trial. J Perianesth Nurs. 2023 Apr;38(2):277-283. doi: 10.1016/j.jopan.2022.07.005. Epub 2022 Oct 29.'}, {'pmid': '27931701', 'type': 'BACKGROUND', 'citation': 'Gursoy A, Candas B, Guner S, Yilmaz S. Preoperative Stress: An Operating Room Nurse Intervention Assessment. J Perianesth Nurs. 2016 Dec;31(6):495-503. doi: 10.1016/j.jopan.2015.08.011. Epub 2016 May 6.'}, {'pmid': '32251126', 'type': 'BACKGROUND', 'citation': 'Delaney LD, Clauw DJ, Waljee JF. The Management of Acute Pain for Musculoskeletal Conditions: The Challenges of Opioids and Opportunities for the Future. J Bone Joint Surg Am. 2020 May 20;102 Suppl 1(Suppl 1):3-9. doi: 10.2106/JBJS.20.00228. No abstract available.'}, {'pmid': '34398809', 'type': 'BACKGROUND', 'citation': 'Morgan H, Nana M, Phillips D, Gallagher S. The Effect of a VIrtual RealiTy Immersive Experience Upon Anxiety Levels, Procedural Understanding, and Satisfaction in Patients Undergoing CArdiac CaTHeterization: The VIRTUAL CATH Trial. J Invasive Cardiol. 2021 Sep;33(9):E681-E686. doi: 10.25270/jic/20.00664. Epub 2021 Aug 8.'}, {'pmid': '37589975', 'type': 'BACKGROUND', 'citation': 'Rizzo MG Jr, Costello JP 2nd, Luxenburg D, Cohen JL, Alberti N, Kaplan LD. Augmented Reality for Perioperative Anxiety in Patients Undergoing Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2329310. doi: 10.1001/jamanetworkopen.2023.29310.'}, {'pmid': '33303283', 'type': 'BACKGROUND', 'citation': 'Cheng JYJ, Wong BWZ, Chin YH, Ong ZH, Ng CH, Tham HY, Samarasekera DD, Devi KM, Chong CS. Preoperative concerns of patients undergoing general surgery. Patient Educ Couns. 2021 Jun;104(6):1467-1473. doi: 10.1016/j.pec.2020.11.010. Epub 2020 Nov 21.'}, {'pmid': '39270596', 'type': 'BACKGROUND', 'citation': 'Chan SL, Sit JWH, Ang WW, Lau Y. Virtual reality-enhanced interventions on preoperative anxiety symptoms in adults undergoing elective surgery: A meta-analysis and meta-regression. Int J Nurs Stud. 2024 Dec;160:104886. doi: 10.1016/j.ijnurstu.2024.104886. Epub 2024 Aug 30.'}, {'pmid': '29705448', 'type': 'BACKGROUND', 'citation': "Ugras GA, Yildirim G, Yuksel S, Ozturkcu Y, Kuzdere M, Oztekin SD. The effect of different types of music on patients' preoperative anxiety: A randomized controlled trial. Complement Ther Clin Pract. 2018 May;31:158-163. doi: 10.1016/j.ctcp.2018.02.012. Epub 2018 Feb 17."}, {'pmid': '33755246', 'type': 'BACKGROUND', 'citation': 'Ruiz Hernandez C, Gomez-Urquiza JL, Pradas-Hernandez L, Vargas Roman K, Suleiman-Martos N, Albendin-Garcia L, Canadas-De la Fuente GA. Effectiveness of nursing interventions for preoperative anxiety in adults: A systematic review with meta-analysis. J Adv Nurs. 2021 Aug;77(8):3274-3285. doi: 10.1111/jan.14827. Epub 2021 Mar 23.'}, {'pmid': '35113840', 'type': 'BACKGROUND', 'citation': 'Leland DP, Pareek A, Therrien E, Wilbur RR, Stuart MJ, Krych AJ, Levy BA, Camp CL. Neurological Complications Following Arthroscopic and Related Sports Surgery: Prevention, Work-up, and Treatment. Sports Med Arthrosc Rev. 2022 Mar 1;30(1):e1-e8. doi: 10.1097/JSA.0000000000000322.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effects of an operating room tour conducted using virtual reality (VR) goggles on anxiety, surgical fear, post-operative pain, satisfaction levels, and physiological parameters in patients undergoing orthopedic surgery.\n\nThe intervention will involve a 360 degree educational video introducing the operating room environment, surgical team roles, and expected patient experience during the perioperative period. This video will be presented using Meta Quest 3 VR goggles. Participants in the intervention group will watch this video before surgery, while the control group will receive standard preoperative education.\n\nThe primary outcomes include changes in preoperative anxiety (STAI-I), surgical fear (Surgical Fear Scale), and physiological parameters (e.g., heart rate, blood pressure, and electrodermal activity). Secondary outcomes include post-operative pain and patient satisfaction. Data will be collected at multiple time points, including before and after the intervention, on the day of surgery, and during the postoperative period.\n\nThe study is designed as a randomized controlled trial with a sample size of 60 participants, equally distributed between intervention and control groups. Data analysis will include appropriate statistical tests based on variable distribution and group comparisons.', 'detailedDescription': "This study is a randomized controlled trial to be conducted on patients undergoing arthroscopic surgery. The intervention group will be shown a 9,5 minute virtual reality (VR) content, created by the researcher, through VR goggles. The video content will be recorded by the researcher and a team using an Insta360 Pro device. The content will be a simulation involving healthcare professionals in various roles. The footage will be taken from the patient's perspective.\n\nOnce the operating room introduction video is completed, expert opinions will be gathered from 10 professionals in the field. Among the experts, 2 will be academicians, 2 will be experienced operating room nurses with at least 10 years of experience, 2 will be orthopedic surgeons, 1 will be a patient who has undergone arthroscopic surgery, 1 will be an anesthesiologist, and 1 will be an anesthesia technician. If the validity index from expert feedback is at least 80%, the video will be finalized.\n\nBefore the training content is shown, the VR goggles will be sanitized using an appropriate antiseptic solution, and then placed on the patient. The training content will consist of a 3D operating room introduction video. The device to be used for this training is a portable VR headset developed by Meta. It offers an advanced VR experience with its Snapdragon XR2 Gen 2 processor and high-resolution screens. Additionally, the device complies with the European Union's CE marking requirements and the Federal Communications Commission (FCC) regulations in the United States.\n\nThe introduction video will feature a patient's perspective and will detail the entire process up until the administration of anesthesia. During the video, the nurse will provide simultaneous narration, which will be heard by the patient through headphones. The content of the video will cover processes such as the patient's exit from the hospital room, transfer to the operating room, surgical safety procedures, introduction of devices used in surgery, prevention of pressure ulcers and hypothermia, and monitoring stages. The nurse will remain with the patient throughout the training.\n\nAfter the training content is shown, measurements will be taken using the scales at specified time intervals. The study will compare the differences in surgical fear, anxiety levels, physiological parameters, pain levels, and satisfaction between the control group and the intervention group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals aged 18-65 years\n* Patients scheduled for arthroscopic surgery\n* Those who have not undergone any previous surgical procedures\n* Patients who will undergo surgery under general anesthesia\n* Individuals without communication barriers\n* Patients with clear consciousness, and orientation to person, place, and time\n* Those with no neurological or psychiatric disorders\n* Individuals with no severe visual or auditory impairments\n\nExclusion Criteria:\n\n* Inability to communicate with the patients\n* Development of a life-threatening health problem after surgery\n* Transition to open surgery during the procedure\n* Patients who wish to withdraw from the study'}, 'identificationModule': {'nctId': 'NCT06906120', 'briefTitle': 'The Effect of Operating Room Introduction With Virtual Reality Glasses on Anxiety, Surgical Fear, and Satisfaction Levels in Patients Undergoing Orthopedic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem University'}, 'officialTitle': 'The Effect of Operating Room Introduction With Virtual Reality Glasses on Anxiety, Surgical Fear, and Satisfaction Levels in Patients Undergoing Orthopedic Surgery', 'orgStudyIdInfo': {'id': 'ORTO2025-VR01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality-Based Education Group', 'interventionNames': ['Behavioral: Virtual Reality-Based Operating Room Education']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Education Group'}], 'interventions': [{'name': 'Virtual Reality-Based Operating Room Education', 'type': 'BEHAVIORAL', 'otherNames': ['VR-Based Operating Room Orientation', 'Virtual Reality Surgical Environment Training'], 'description': 'For the Intervention Group:\n\nWritten informed consent will be obtained one day before surgery when patients visit the anesthesia clinic.\n\nSubsequently, the Patient Introduction Form, State-Trait Anxiety Inventory (STAI-I, STAI-II), and Surgical Fear Scale will be completed, and electrodermal activity data and physiological parameters will be recorded for 5 minutes.\n\nParticipants will watch a 3D training video created by the researcher using Meta Quest 3 virtual reality headsets. This video will provide an introduction to the operating room environment and related procedures.\n\nAfter the video, physiological parameters will be recorded again, and STAI-I and the Surgical Fear Scale will be completed.\n\nOn the day of the surgery, after the patients are admitted and necessary preparations are made, STAI-I and the Surgical Fear Scale will be completed again, and physiological parameters will be recorded.\n\nElectrodermal activity data will be recorded 15-20 minutes before anesthesia is administ', 'armGroupLabels': ['Virtual Reality-Based Education Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34642', 'city': 'Istanbul', 'state': 'Ataşehir', 'country': 'Turkey (Türkiye)', 'facility': 'Acibadem Atasehir Hospitla', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34662', 'city': 'Istanbul', 'state': 'ataşehir', 'country': 'Turkey (Türkiye)', 'facility': 'Acibadem Altunizade Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Rana Güngör Sevinç, Uzman Hemşire', 'role': 'CONTACT', 'email': 'rana.sevinc@acibadem.edu.tr', 'phone': '+905382860008', 'phoneExt': '+902165004301'}, {'name': 'Sonay Göktaş, Prof. Dr.', 'role': 'CONTACT', 'email': 'sonay.goktas@sbu.edu.tr', 'phone': '+905324567776'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Start Date: 01.01.2026 (When the publication process begins) End Date: 01.07.2026 (6 months after publication)', 'ipdSharing': 'YES', 'description': "We plan to share the data through open access in the relevant journal, after anonymizing the data. No personally identifiable information will be included, and only anonymized data will be shared. We plan to make the data accessible on the journal's data platform after the publication date of the study."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acibadem University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Acibadem Altunizade Hospital, Istanbul', 'class': 'UNKNOWN'}, {'name': 'Acibadem Atasehir Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator Rana Güngör Sevinç', 'investigatorFullName': 'Rana Güngör Sevinç', 'investigatorAffiliation': 'Acibadem University'}}}}