NCT07620873

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

June 2, 2026

Status Verified

June 1, 2026

Enrollment Period

10 months

First QC Date

May 23, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

Virtual RealityPreoperative EducationUrolithiasisAnxietySelf-Care AbilityCognitive Load

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline before intervention, 2 hours after intervention, and postoperative day 1

Secondary Outcomes (3)

  • Urolithiasis Surgery Knowledge Questionnaire Score

    Baseline before intervention and 2 hours after intervention

  • Postoperative Self-Care Ability Score Measured by the Urolithiasis Self-Care Ability Scale

    Postoperative day 1

  • Cognitive Load Score Measured by the Cognitive Load Questionnaire

    2 hours after intervention

Study Arms (3)

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.

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.

Behavioral: Two-Tier VR Education

Interventions

VR EducationBEHAVIORAL

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.

VR Education

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.

Two-Tier VR Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keelung Chang Gung Memorial Hospital

Keelung, 204, Taiwan

Location

MeSH Terms

Conditions

UrolithiasisKidney CalculiAnxiety Disorders

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNephrolithiasisKidney DiseasesUrinary CalculiCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

wellin Huang, RN, MSN Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Graduate Student, School of Nursing, Taipei Medical University

Study Record Dates

First Submitted

May 23, 2026

First Posted

June 2, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

June 2, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations