| Registry | NCT07483866, acronym VR |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, other |
| Enrollment | 200 (Estimated) |
| Sponsor | Jia-Ling Wang (Other) |
| Conditions | Preoperative Anxiety |
| Interventions | Virtual reality, Conventional Video (Behavioral) |
| Dates | start 2026-09-22 (estimated), primary completion 2026-12-31 (estimated), completion 2027-12-31 (estimated), first posted 2026-03-19, last updated 2026-09-01 |
Related Papers Related Patents Related Grants Related Experts
All trials for Preoperative Anxiety All trials of Virtual reality All trials of Conventional Video
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.
This study adopted a randomized controlled trial design. The inclusion criteria for the study subjects were adults aged 18 years or older who were undergoing scheduled hip and knee replacement surgery and were scheduled to undergo spinal anesthesia, had no anxiety disorders, no visual or hearing impairments, were conscious, could understand and read Chinese, and had a general health status of the American Society of Anesthesiologists grade I to III; the exclusion criteria were those who had head trauma, had a history of dizziness, and had to be transferred to the intensive care unit due to illness. The cases were assigned to the experimental group (virtual reality education and conventional care) and the control group (conventional care and unit health education film) by block randomization. The intervention measure was a virtual reality education intervention program. The data collection method was a total of four repeated measurements including: baseline value (one day before surgery), from the day of surgery to the front desk of the operating room, one day after surgery, and three days after surgery. The research tools included basic information, situation-trait anxiety scale, anxiety visual scale, pain visual scale, Virtual Reality Education Satisfaction Questionnaire and physiological indicators for data collection.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Experimental Group | Experimental | Behavioral: Virtual reality | Participants in this arm will receive a 10-15 minute immersive virtual reality (VR) education program one day prior to surgery. Utilizing a head-mounted display (HMD), patients will experience a 360-degree simulated walkthrough of the operating room environment, the spinal anesthesia procedure (including positioning and sensations), and post-operative recovery exercises. The program is designed to reduce preoperative anxiety through sensory immersion and procedural familiarity. This intervention is provided in addition to standard institutional nursing care. |
| Control Group | Active comparator | Behavioral: Conventional Video | Participants in this arm will receive standard health education via a 2D video program one day prior to surgery. The video, lasting approximately 10-15 minutes, is delivered through a tablet or television screen. The educational content is identical to the experimental group, including a walkthrough of the operating room environment, spinal anesthesia procedures, and post-operative recovery exercises. This represents the current standard of care for preoperative instruction. All participants also receive standard institutional nursing care. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: 1. Must be 18 years of age or older. 2. Must be scheduled for orthopedic surgery and be scheduled to undergo spinal anesthesia. 3. Must have no anxiety disorders, no visual or auditory impairments, be fully conscious, and be able to understand and read Chinese. 4. Must be classified as a Class I to III by the American College of Anesthesiologists. Exclusion Criteria: 1. Previous head injury. 2. History of dizziness. 3. Patient requiring transfer to the intensive care unit due to their condition.