About this trial
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.
Participants 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.
Randomization 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.
Data 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.
The research instruments used for assessment included:
A 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be 18 years of age or older.
Must be scheduled for orthopedic surgery and be scheduled to undergo spinal anesthesia.
Must have no anxiety disorders, no visual or auditory impairments, be fully conscious, and be able to understand and read Chinese.
Must be classified as a Class I to III by the American College of Anesthesiologists.
Disqualifiers
Previous head injury.
History of dizziness.
Patient requiring transfer to the intensive care unit due to their condition.
Trial design
Parallel
Treatments tested in this trial
Virtual reality
BehavioralIntervention Name: Virtual Reality-Based Preoperative Education Intervention Description: A 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.
Conventional Video
BehavioralIntervention Name: Conventional Health Education Video Intervention Description: A 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.
Treatment groups
Trial outcomes
Primary outcomes
Change From Baseline in Anxiety Scores on the State-Trait Anxiety Inventory (STAI-S)
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.
Secondary outcomes
Postoperative Pain Intensity as Measured by the Visual Analog Scale (VAS)
Participants rate their pain on a 100 mm line (0 = no pain, 100 = worst possible pain). Higher scores reflect higher pain intensity.
Change From Baseline in Mean Heart Rate (Beats Per Minute)
Heart rate will be measured via a pulse oximeter to assess physiological stress response.
Locations
Sponsors and contacts
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Jia-Ling Wang
Lead sponsor
Far Eastern Memorial Hospital
Sponsor institution
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