UrolithiasisVR-URONCT07620873
Effects of Virtual Reality Education on Anxiety and Learning in Patients Undergoing Urolithiasis Surgery
A study testing VR Education and Two-Tier VR Education in people with Urolithiasis and Kidney Stone, run by Wei-Lin, Huang at 1 site in Taiwan.
Trial summary
This randomized controlled trial aims to evaluate the effects of two-tier virtual reality-based preoperative education on anxiety, learning knowledge, self-care ability, and cognitive load in patients undergoing urolithiasis surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis, Kidney Stone, Ureter Stones
- What is being tested?
- VR Education and Two-Tier VR Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Jun 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Keelung Chang Gung Memorial Hospital
Keelung, 204
About this study
Official title: The Effects of Two-Tier Test-Based Virtual Reality Education on Anxiety, Knowledge, Self-Care Ability, and Cognitive Load in Patients Undergoing Urolithiasis Surgery
This randomized controlled trial aims to evaluate the effects of two-tier virtual reality-based preoperative education on anxiety, learning knowledge, self-care ability, and cognitive load in patients undergoing urolithiasis surgery. Participants will be randomly assigned to routine education, standard virtual reality education, or two-tier virtual reality education groups. Outcomes will be assessed using anxiety scales, knowledge questionnaires, self-care ability measures, and cognitive load assessments before and after the intervention.
Read the 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.
- Conditions
- Urolithiasis, Kidney Stone, Ureter Stones
- Being tested
- VR Education, Two-Tier VR Education
- Keywords
- Virtual Reality, Preoperative Education, Urolithiasis, Anxiety, Self-Care Ability, Cognitive Load
- Medical subject headings
- Urolithiasis, Kidney Calculi, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR EducationBehavioural
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.
Two-Tier VR EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine Patient Education | No intervention | Participants receive routine preoperative education provided by clinical nursing staff before urolithiasis surgery. |
| VR Education | Experimental | Participants receive standard virtual reality-based preoperative education before urolithiasis surgery. Receives: Behavioral: VR Education |
| Two-Tier VR Education | Experimental | Participants receive two-tier virtual reality-based preoperative education with integrated interactive questioning and feedback before urolithiasis surgery. Receives: Behavioral: Two-Tier VR Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Score Measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) and Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)
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.
Measured: Baseline before intervention, 2 hours after intervention, and postoperative day 1
Secondary outcomes (3)
Urolithiasis Surgery Knowledge Questionnaire Score
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
Measured: Baseline before intervention and 2 hours after intervention
Postoperative Self-Care Ability Score Measured by the Urolithiasis Self-Care Ability Scale
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.
Measured: Postoperative day 1
Cognitive Load Score Measured by the Cognitive Load Questionnaire
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.
Measured: 2 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start28 Jun 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three parallel groups: routine education, standard virtual reality education, or two-tier virtual reality education. Outcomes will be compared across groups before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei-Lin, Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei-Lin, Huang, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620873
- Sponsor's protocol ID
- 202600523B0
- Acronym
- VR-URO
- Status last verified
- Jun 2026
- First submitted
- 23 May 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Two-Tier Test-Based Virtual Reality Education on Anxiety, Knowledge, Self-Care Ability, and Cognitive Load in Patients Undergoing Urolithiasis Surgery
- ClinicalTrials.gov ID
- NCT07620873
- Acronym / sponsor ID
- VR-URO / 202600523B0
- Conditions
- Urolithiasis, Kidney Stone, Ureter Stones
- Keywords
- Virtual Reality, Preoperative Education, Urolithiasis, Anxiety, Self-Care Ability, Cognitive Load
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Wei-Lin, HuangUniversity, hospital or other
- Study start
- 28 Jun 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aims to evaluate the effects of two-tier virtual reality-based preoperative education on anxiety, learning knowledge, self-care ability, and cognitive load in patients undergoing urolithiasis surgery. Participants will be randomly assigned to routine education, standard virtual reality education, or two-tier virtual reality education groups. Outcomes will be assessed using anxiety scales, knowledge questionnaires, self-care ability measures, and cognitive load assessments before and after the intervention.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel groups: routine education, standard virtual reality education, or two-tier virtual reality education. Outcomes will be compared across groups before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Routine Patient Education | No intervention | –Participants receive routine preoperative education provided by clinical nursing staff before urolithiasis surgery. |
| VR Education | Experimental | Behavioral: VR EducationParticipants receive standard virtual reality-based preoperative education before urolithiasis surgery. |
| Two-Tier VR Education | Experimental | Behavioral: Two-Tier VR EducationParticipants receive two-tier virtual reality-based preoperative education with integrated interactive questioning and feedback before urolithiasis surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR EducationParticipants 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. | Behavioural | VR Education |
| Two-Tier VR EducationParticipants 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. | Behavioural | Two-Tier VR Education |
Primary outcome
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.
3 secondary outcomes
Urolithiasis Surgery Knowledge Questionnaire Score
Time frame: 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
Cognitive Load Score Measured by the Cognitive Load Questionnaire
Time frame: 2 hours after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Education and Two-Tier VR Education in people with Urolithiasis and Kidney Stone, run by Wei-Lin, Huang at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact wellin Huang, RN, MSN Student (+886 953713535, hwl0111@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.