- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07620873
Effects of Virtual Reality Education on Anxiety and Learning in Patients Undergoing Urolithiasis Surgery (VR-URO)
The Effects of Two-Tier Test-Based Virtual Reality Education on Anxiety, Knowledge, Self-Care Ability, and Cognitive Load in Patients Undergoing Urolithiasis Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Preoperative anxiety is a common concern among patients undergoing urolithiasis surgery and may adversely affect perioperative experiences, treatment adherence, and postoperative recovery. Conventional preoperative education is often limited by time constraints, variability in information delivery, and insufficient patient engagement.
Virtual reality (VR)-based education has emerged as an innovative educational approach that provides immersive and interactive learning experiences. Previous studies have suggested that VR may improve patient understanding of surgical procedures and reduce anxiety by familiarizing patients with the perioperative environment. However, most existing VR education programs provide information passively and may not adequately identify or correct patient misconceptions.
The present study introduces a two-tier virtual reality educational approach that integrates immersive VR scenarios with structured knowledge assessment and feedback mechanisms. By encouraging participants to actively process information and receive immediate clarification of misunderstandings, the intervention is expected to enhance learning effectiveness and support patient self-management.
This randomized controlled trial aims to examine whether a two-tier VR educational strategy can provide additional benefits beyond standard VR education and routine preoperative instruction for patients undergoing urolithiasis surgery. Findings from this study may contribute to the development of more effective patient-centered educational interventions and provide evidence for the integration of advanced VR technologies into perioperative nursing practice.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: wellin Huang, RN, MSN Student
- Phone Number: +886 953713535
- Email: hwl0111@gmail.com
Study Locations
-
-
-
Keelung, Taiwan, 204
- Keelung Chang Gung Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients scheduled to undergo urolithiasis surgery with procedure codes 77026B, 77027B, 77028B, or 76016B.
- Aged 18 years or older.
- Conscious and mentally alert.
- Able to communicate in Mandarin Chinese and read written text.
- Able to understand and operate virtual reality equipment.
Exclusion Criteria:
- Patients with current psychiatric disorders or substance abuse.
- Patients with hearing or visual impairment.
- Patients with visual dizziness, vertigo, or virtual reality motion sickness symptoms.
- Patients who are unable to cooperate or unwilling to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Routine Patient Education
Participants receive routine preoperative education provided by clinical nursing staff before urolithiasis surgery.
|
|
|
Experimental: VR Education
Participants receive standard virtual reality-based preoperative education before urolithiasis surgery.
|
Participants receive standard virtual reality-based preoperative education before urolithiasis surgery.
The VR program includes immersive 360-degree educational content covering the preoperative process, operating room environment, postoperative care, and self-care instructions.
|
|
Experimental: Two-Tier VR Education
Participants receive two-tier virtual reality-based preoperative education with integrated interactive questioning and feedback before urolithiasis surgery.
|
Participants receive two-tier virtual reality-based preoperative education before urolithiasis surgery.
The intervention combines immersive 360-degree VR educational content with a two-tier testing mechanism designed to enhance learning comprehension, self-care knowledge, and cognitive engagement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety Score Measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) and Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)
Time Frame: Baseline before intervention, 2 hours after intervention, and postoperative day 1
|
Anxiety will be assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) and the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The APAIS consists of 6 items scored on a 5-point Likert scale. Total scores range from 6 to 30, with higher scores indicating greater preoperative anxiety and information needs. The HADS-A consists of 7 items scored from 0 to 3. Total scores range from 0 to 21, with higher scores indicating greater anxiety. |
Baseline before intervention, 2 hours after intervention, and postoperative day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Urolithiasis Surgery Knowledge Questionnaire Score
Time Frame: Baseline before intervention and 2 hours after intervention
|
Knowledge regarding perioperative care for urolithiasis surgery will be assessed using a researcher-developed Urolithiasis Surgery Knowledge Questionnaire. The baseline questionnaire consists of 10 multiple-choice items and the post-intervention questionnaire consists of 20 multiple-choice items covering surgical preparation, operating room orientation, perioperative care, urinary catheter care, Double-J stent management, dietary management, hydration, complication recognition, and prevention of stone recurrence. Scores range from 0 to 10 at baseline and from 0 to 20 after intervention. Higher scores indicate better understanding of urolithiasis surgery and postoperative self-care |
Baseline before intervention and 2 hours after intervention
|
|
Postoperative Self-Care Ability Score Measured by the Urolithiasis Self-Care Ability Scale
Time Frame: Postoperative day 1
|
Postoperative self-care ability will be assessed using the Urolithiasis Postoperative Self-Care Ability Scale developed by Hu et al. (2024). The scale consists of 30 items across five domains, including disease management, diet and fluid intake, psychosocial management, activity and elimination, and disease-related information. Each item is rated on a 5-point Likert scale. Total scores range from 30 to 150. Higher scores indicate better postoperative self-care ability. |
Postoperative day 1
|
|
Cognitive Load Score Measured by the Cognitive Load Questionnaire
Time Frame: 2 hours after intervention
|
Cognitive load will be assessed using the Cognitive Load Questionnaire developed by Klepsch et al. (2017). The questionnaire contains 8 items assessing intrinsic cognitive load, extraneous cognitive load, and germane cognitive load. Each item is rated on a 5-point Likert scale. Total scores range from 8 to 40. Higher scores indicate greater perceived cognitive load during learning. |
2 hours after intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Mental Disorders
- Male Urogenital Diseases
- Calculi
- Pathological Conditions, Anatomical
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urinary Calculi
- Nephrolithiasis
- Pathological Conditions, Signs and Symptoms
- Kidney Calculi
- Anxiety Disorders
- Urolithiasis
Other Study ID Numbers
- 202600523B0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Urolithiasis
-
Beni-Suef UniversityRecruiting
-
Singapore General HospitalUnknown
-
Kırıkkale UniversityCompletedKidney Calculi Nephrolithiasis Urolithiasis Renal Stone
-
University of Sao Paulo General HospitalCompletedUrolithiasis and Aging | Renal Calcul and Metabolic Diseases | Urolithiasis and OsteoporosisBrazil
-
EULIS Colloborative Research Working GroupUnknownKidney Calculi | Nephrolithiasis | Patient Compliance | Calcium Oxalate Urolithiasis
-
Catalysis SLCompletedKidney Calculi | Kidney Injury | Urolithiasis | Ureteral Calculi | Ureteral Obstruction | Renal Disease | Renal Stone | Ureteral Injury | Renal Injury | Urolithiasis, Calcium Oxalate | Urolithiasis; Lower Urinary TractNicaragua
-
University of Alabama at BirminghamNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University...RecruitingHealthy | Kidney Calculi | Nephrolithiasis | Urolithiasis | Kidney Stone | Nephrolithiasis, Calcium Oxalate | Oxaluria | Urolithiasis, Calcium Oxalate | Oxalate UrolithiasisUnited States
-
London Health Sciences Centre Research Institute...St. Joseph's Health Care LondonCompletedKidney Calculi | Nephrolithiasis | Kidney Stone | Human | Calcium Oxalate Urolithiasis | Vitamin K 2 | Calcium Oxalate Kidney Stones | Calcium Phosphate UrolithiasisCanada
-
University of Alabama at BirminghamNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University...RecruitingHealthy | Kidney Calculi | Nephrolithiasis | Urolithiasis | Healthy Volunteer | Kidney Stones | Nephrolithiasis, Calcium Oxalate | Urolithiasis, Calcium Oxalate | Oxalate UrolithiasisUnited States
-
University of Alabama at BirminghamNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University...RecruitingKidney Calculi | Nephrolithiasis | Urolithiasis | Kidney Stone | Nephrolithiasis, Calcium Oxalate | Oxaluria | Urolithiasis, Calcium Oxalate | Oxalate UrolithiasisUnited States
Clinical Trials on VR Education
-
Asia UniversityCompletedDementia EducationTaiwan
-
Cukurova UniversityNot yet recruitingPregnancy | Exercise | Virtual RealityTurkey
-
Medical College of WisconsinMarquette University; Froedtert HospitalTerminatedStress | Anxiety | Satisfaction, Patient | Information Needs | PreparednessUnited States
-
Poliklinika Agel, Dopravni zdravotnictvi a.s.Recruiting
-
Marmara UniversityRecruitingStress | Anxiety | Cholecystectomy, Laparoscopic | Patient Satisfaction | Sleep Quality | Virtual Reality | Patient Education | Patient Outcomes | Family Interviews | Operating RoomTurkey
-
University of MiamiNational Heart, Lung, and Blood Institute (NHLBI)Enrolling by invitationHypertension | StressUnited States
-
The Hong Kong Polytechnic UniversityEnrolling by invitationHealthy ParticipantsChina
-
Jia-Ling WangNot yet recruiting
-
National Taiwan Normal UniversityCompletedDementia | Mild Cognitive Impairment (MCI) | Virtual Reality | Health Education | eHealth | Health Literacy | Self-Efficacy | Attitude to Health | Older Adults (65 Years and Older)Taiwan
-
University of UtahBelmont University; Benchmark Physical TherapyCompleted