Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:40 AM
Study NCT ID:
NCT07379450
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-30
First Post:
2026-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Virtual Reality-enhanced Interventions on Preoperative Anxiety in Adults Undergoing Elective Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-27', 'studyFirstSubmitDate': '2026-01-21', 'studyFirstSubmitQcDate': '2026-01-27', 'lastUpdatePostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preoperative anxiety', 'timeFrame': 'Baseline, Immediate post-intervention, Day of surgery', 'description': 'Preoperative anxiety will be measured using the Short Chinese Version of the State-Trait Anxiety Inventory (Du et al., 2022). Items are rated on a 4-point Likert scale ranging from 1 to 4, with higher scores indicating higher anxiety. The Short Chinese Version of the State-Trait Anxiety Inventory demonstrates good psychometric properties.'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'Baseline, Immediate post-intervention, Day of surgery', 'description': 'Heart rate will be measured in beats per minute (bpm) using physiological monitors to provide a more objective measurement for anxiety.'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline, Immediate post-intervention, Day of surgery', 'description': 'Blood pressure will be measured in millimeters of mercury (mmHg) using physiological monitors to provide a more objective measurement for anxiety.'}, {'measure': 'Temperature', 'timeFrame': 'Baseline, Immediate post-intervention, Day of surgery', 'description': 'Temperature will be measured in degrees Celsius (°C) using tympanic thermometers to provide a more objective measurement for anxiety.'}, {'measure': 'Life satisfaction', 'timeFrame': 'Baseline, Immediate post-intervention, Day of surgery, Post-operative day 7', 'description': 'Life satisfaction will be measured using the Chinese version of Satisfaction with Life Scale (SWLS) (Diener et al., 1985). Items are rated on a 7-point Likert scale ranging from 1 to 7, with higher scores indicating higher life satisfaction. The Chinese version of Satisfaction with Life Scale (SWLS) demonstrates good psychometric properties (Wu \\& Yao, 2006).'}, {'measure': 'Evaluation of Virtual reality-enhanced interventions questionnaire', 'timeFrame': 'Immediate post-intervention', 'description': 'Virtual reality-enhanced interventions questionnaire was developed to evaluate virtual reality-enhanced interventions in terms of programme content, content adequacy, content usefulness, willingness to recommend others, satisfaction, and improvement suggestions. The questions are either 4-point Likert scale or open-end questions. The score ranges from 1 to 4, higher scores indicate higher satisfcation and higher agreement.'}, {'measure': 'Postoperative anxiety', 'timeFrame': 'Post-operative day 7', 'description': 'Postoperative anxiety will be measured using the Short Chinese Version of the State-Trait Anxiety Inventory (Du et al., 2022). Items are rated on a 4-point Likert scale ranging from 1 to 4, with higher scores indicating higher anxiety. The Short Chinese Version of the State-Trait Anxiety Inventory demonstrates good psychometric properties.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preoperative Anxiety', 'Virtual Reality'], 'conditions': ['Preoperative Anxiety']}, 'descriptionModule': {'briefSummary': 'Brief Summary: Preoperative anxiety is a common phenomenon in surgical patients, with a pooled global prevalence of 48%. Surgical patients with preoperative anxiety may negatively impact their psychological health and surgical outcomes. Recent studies have revealed the promising effects of virtual reality-enhanced interventions to improve preoperative anxiety symptoms among adults undergoing elective surgery.\n\nThere is a lack of interventional studies to compare and evaluate the co-designed preoperative virtual reality-enhanced interventions in adult surgical patients.\n\nThis study aims to examine the effects of co-designed virtual reality educational video and virtual reality distraction video on preoperative anxiety symptoms, vital signs, Satisfaction with Life Scale (SWLS), and postoperative anxiety compared to usual care. This study will contribute by evaluating evidence-based, user-centered VIPA that may be effective for improving preoperative anxiety among adult surgical patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age aged ≥18 years old\n* Surgical patients attending Nurse Pre-anaesthetic Assessment Clinic (NPAC)\n* American Society of Anesthesiology (ASA) physical status ASA I or ASA II\n* Able to communicate in Chinese\n\nExclusion Criteria:\n\n* Patients who have a cognitive, communication or physical impairment precluding their ability to complete the study\n* Patients who are prone to epilepsy or other neurological conditions'}, 'identificationModule': {'nctId': 'NCT07379450', 'acronym': 'VIPA', 'briefTitle': 'Effectiveness of Virtual Reality-enhanced Interventions on Preoperative Anxiety in Adults Undergoing Elective Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Official Title: Effectiveness of Virtual Reality-enhanced Interventions on Preoperative Anxiety in Adults Undergoing Elective Surgery: A 3-arm Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'CIRB-2025-224-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Group 1 (Education approach)', 'description': 'Participants in Virtual Reality Group 1 (Education approach) will receive a co-designed virtual reality educational 6-minute video via VR headset. The virtual reality educational video includes three main scenes, consisting of preoperative, intraoperative and postoperative content located at operating theatre reception, operating theatre, and post-anaesthetic care unit respectively.', 'interventionNames': ['Other: Virtual Reality']}, {'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Group 2 (Distraction approach)', 'description': 'Participants in Virtual Reality Group 2 (Distraction approach) will receive a virtual reality distraction 6-minute video via VR headset. The virtual reality distraction video includes immersive natural scenes with concurrent music, without educational component.', 'interventionNames': ['Other: Virtual Reality']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants in control group will receive usual care only.'}], 'interventions': [{'name': 'Virtual Reality', 'type': 'OTHER', 'description': 'The Virtual Reality-enhanced Interventions on Preoperative Anxiety for adults undergoing elective surgery (VIPA) was developed based on theoretical basis, systematic review evidence, and qualitative study.', 'armGroupLabels': ['Virtual Reality Group 1 (Education approach)', 'Virtual Reality Group 2 (Distraction approach)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sin Lun CHAN', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sin Lun CHAN', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}