The Effectiveness of a Virtual Reality-based Educational Intervention on Anxiety Symptoms, Pain Levels, and Physiological Indicator Outcomes in Surgical Patients

NCT07483866 | Not Yet Recruiting DMC

• 1 other identifier: 114190-E
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Preoperative Anxiety

Keywords

Preoperative anxiety

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (1 day before surgery), day of surgery (pre-operation), 24 hours post-operation, and 72 hours post-operation.

Secondary Outcomes (2)

• Postoperative Pain Intensity as Measured by the Visual Analog Scale (VAS)

  Baseline (1 day before surgery), day of surgery (pre-operation), 24 hours post-operation, and 72 hours post-operation.

• Change From Baseline in Mean Heart Rate (Beats Per Minute)

  Baseline (1 day before surgery), day of surgery (pre-operation), 24 hours post-operation, and 72 hours post-operation.

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Behavioral: Virtual reality

Control Group

ACTIVE COMPARATOR

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.

Behavioral: Conventional Video

Interventions

Virtual reality BEHAVIORAL

Intervention 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.

Also known as: VR Education

Experimental Group

Conventional Video BEHAVIORAL

Intervention 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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous head injury.
• History of dizziness.
• Patient requiring transfer to the intensive care unit due to their condition.

Sponsors & Collaborators

• Jia-Ling Wang: lead

Related Publications (1)

• Liu X, Wang H, Zhao Q, Wang R, Cao H. The effectiveness of virtual reality in relieving anxiety and pain for adult oral surgical procedures patients: a systematic review and meta-analysis. Oral Surg Oral Med Oral Pathol Oral Radiol. 2026 Apr;141(4):450-464. doi: 10.1016/j.oooo.2025.10.002. Epub 2025 Oct 16.

  PMID: 41407647 RESULT

Related Links

• The objective of this systematic review and meta-analysis was to assess the effectiveness of virtual reality interventions in alleviating intraoperative pain and anxiety among adult patients undergoing oral surgical procedures.

Central Study Contacts

Jia Ling WANG

CONTACT

886+0938562061; g462112026@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Interventional group (experimental group): Received VR-based intervention as the main treatment, while also receiving routine care. Control group: Received standard care and alternative interventions, such as written and verbal interventions, as the baseline for comparison.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 19, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03