Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 2:08 AM
Study NCT ID:
NCT07483866
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of a Virtual Reality-based Educational Intervention on Anxiety Symptoms, Pain Levels, and Physiological Indicator Outcomes in Surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Interventional group (experimental group): Received VR-based intervention as the main treatment, while also receiving routine care.\n\nControl group: Received standard care and alternative interventions, such as written and verbal interventions, as the baseline for comparison.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-12', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Anxiety Scores on the State-Trait Anxiety Inventory (STAI-S)', 'timeFrame': 'Baseline (1 day before surgery), day of surgery (pre-operation), 24 hours post-operation, and 72 hours post-operation.', 'description': "The State-Trait Anxiety Inventory (STAI-S) is a 20-item self-report scale used to measure the participant's current state of anxiety. Each item is scored on a 4-point Likert scale (1 to 4). The total score ranges from 20 to 80, where a higher score indicates a higher level of situational anxiety."}], 'secondaryOutcomes': [{'measure': 'Postoperative Pain Intensity as Measured by the Visual Analog Scale (VAS)', 'timeFrame': 'Baseline (1 day before surgery), day of surgery (pre-operation), 24 hours post-operation, and 72 hours post-operation.', 'description': 'Participants rate their pain on a 100 mm line (0 = no pain, 100 = worst possible pain). Higher scores reflect higher pain intensity.'}, {'measure': 'Change From Baseline in Mean Heart Rate (Beats Per Minute)', 'timeFrame': 'Baseline (1 day before surgery), day of surgery (pre-operation), 24 hours post-operation, and 72 hours post-operation.', 'description': 'Heart rate will be measured via a pulse oximeter to assess physiological stress response.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preoperative anxiety'], 'conditions': ['Preoperative Anxiety']}, 'referencesModule': {'references': [{'pmid': '41407647', 'type': 'RESULT', 'citation': 'Liu X, Wang H, Zhao Q, Wang R, Cao H. The effectiveness of virtual reality in relieving anxiety and pain for adult oral surgical procedures patients: a systematic review and meta-analysis. Oral Surg Oral Med Oral Pathol Oral Radiol. 2026 Apr;141(4):450-464. doi: 10.1016/j.oooo.2025.10.002. Epub 2025 Oct 16.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/41407647/', 'label': 'The objective of this systematic review and meta-analysis was to assess the effectiveness of virtual reality interventions in alleviating intraoperative pain and anxiety among adult patients undergoing oral surgical procedures.'}]}, 'descriptionModule': {'briefSummary': 'Study Design and Participants This study employed a prospective, randomized controlled trial (RCT) design. A total of two study arms were established: an experimental group receiving a virtual reality (VR) education intervention combined with conventional care, and a control group receiving a unit health education film with conventional care.\n\nParticipants were recruited based on the following inclusion criteria: adults aged 18 years or older scheduled for elective hip or knee replacement surgery under spinal anesthesia; an American Society of Anesthesiologists (ASA) physical status grade of I to III; clear consciousness with the ability to read and understand Chinese; and no prior diagnosis of anxiety disorders or significant visual/hearing impairments. Patients were excluded if they had a history of head trauma or chronic dizziness, or if they required post-operative transfer to the intensive care unit (ICU) due to medical complications.\n\nRandomization and Intervention Eligible participants were assigned to either the experimental or control group using block randomization to ensure balanced group sizes. The primary intervention for the experimental group consisted of a structured Virtual Reality Education Program, while the control group received standard institutional health education via video.\n\nData Collection and Instrumentation A repeated-measures approach was utilized for data collection across four distinct time points: (1) baseline (one day prior to surgery), (2) pre-operative arrival at the operating room holding area on the day of surgery, (3) one day post-operatively, and (4) three days post-operatively.\n\nThe research instruments used for assessment included:\n\nA demographic profile sheet. The State-Trait Anxiety Inventory (STAI). The Visual Analogue Scale for Anxiety (VAS-A). The Visual Analogue Scale for Pain (VAS-P). A Virtual Reality Education Satisfaction Questionnaire. Standardized physiological indicators.', 'detailedDescription': 'This study adopted a randomized controlled trial design. The inclusion criteria for the study subjects were adults aged 18 years or older who were undergoing scheduled hip and knee replacement surgery and were scheduled to undergo spinal anesthesia, had no anxiety disorders, no visual or hearing impairments, were conscious, could understand and read Chinese, and had a general health status of the American Society of Anesthesiologists grade I to III; the exclusion criteria were those who had head trauma, had a history of dizziness, and had to be transferred to the intensive care unit due to illness. The cases were assigned to the experimental group (virtual reality education and conventional care) and the control group (conventional care and unit health education film) by block randomization. The intervention measure was a virtual reality education intervention program. The data collection method was a total of four repeated measurements including: baseline value (one day before surgery), from the day of surgery to the front desk of the operating room, one day after surgery, and three days after surgery. The research tools included basic information, situation-trait anxiety scale, anxiety visual scale, pain visual scale, Virtual Reality Education Satisfaction Questionnaire and physiological indicators for data collection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Must be 18 years of age or older.\n2. Must be scheduled for orthopedic surgery and be scheduled to undergo spinal anesthesia.\n3. Must have no anxiety disorders, no visual or auditory impairments, be fully conscious, and be able to understand and read Chinese.\n4. Must be classified as a Class I to III by the American College of Anesthesiologists.\n\nExclusion Criteria:\n\n1. Previous head injury.\n2. History of dizziness.\n3. Patient requiring transfer to the intensive care unit due to their condition.'}, 'identificationModule': {'nctId': 'NCT07483866', 'acronym': 'VR', 'briefTitle': 'The Effectiveness of a Virtual Reality-based Educational Intervention on Anxiety Symptoms, Pain Levels, and Physiological Indicator Outcomes in Surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': 'The Effectiveness of a Virtual Reality-based Educational Intervention on Anxiety Symptoms, Pain Levels, and Physiological Indicator Outcomes in Surgical Patients', 'orgStudyIdInfo': {'id': '114190-E'}, 'secondaryIdInfos': [{'id': '114190-E', 'type': 'OTHER_GRANT', 'domain': 'FarEasternMH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Participants in this arm will receive a 10-15 minute immersive virtual reality (VR) education program one day prior to surgery. Utilizing a head-mounted display (HMD), patients will experience a 360-degree simulated walkthrough of the operating room environment, the spinal anesthesia procedure (including positioning and sensations), and post-operative recovery exercises. The program is designed to reduce preoperative anxiety through sensory immersion and procedural familiarity. This intervention is provided in addition to standard institutional nursing care.', 'interventionNames': ['Behavioral: Virtual reality']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Participants in this arm will receive standard health education via a 2D video program one day prior to surgery. The video, lasting approximately 10-15 minutes, is delivered through a tablet or television screen. The educational content is identical to the experimental group, including a walkthrough of the operating room environment, spinal anesthesia procedures, and post-operative recovery exercises. This represents the current standard of care for preoperative instruction. All participants also receive standard institutional nursing care.', 'interventionNames': ['Behavioral: Conventional Video']}], 'interventions': [{'name': 'Virtual reality', 'type': 'BEHAVIORAL', 'otherNames': ['VR Education'], 'description': 'Intervention Name: Virtual Reality-Based Preoperative Education\n\nIntervention Description:\n\nA 10-15 minute immersive virtual reality (VR) education program administered via a head-mounted display (HMD) one day prior to surgery. The simulation provides a 360-degree interactive walkthrough of the operating room environment and the spinal anesthesia procedure (including patient positioning and sensory expectations). This intervention aims to reduce preoperative anxiety through high-fidelity sensory immersion. It is provided in addition to standard conventional nursing care.', 'armGroupLabels': ['Experimental Group']}, {'name': 'Conventional Video', 'type': 'BEHAVIORAL', 'description': 'Intervention Name: Conventional Health Education Video\n\nIntervention Description:\n\nA 10-15 minute standard health education video delivered via a tablet or television screen one day prior to surgery. The video content is identical to the experimental group, covering the surgical environment, spinal anesthesia steps, and post-operative recovery exercises, but presented in a traditional 2D, non-immersive format. This group represents the current standard of care for preoperative education at the clinical site.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jia Ling WANG', 'role': 'CONTACT', 'email': 'g462112026@tmu.edu.tw', 'phone': '886+0938562061'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "a plan isn't set"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jia-Ling Wang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jia-Ling Wang', 'investigatorAffiliation': 'Far Eastern Memorial Hospital'}}}}