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

March 17, 2026 updated by: Jia-Ling Wang

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
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

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.

Other Names:
  • VR Education
Active Comparator: Control Group
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Anxiety Scores on the State-Trait Anxiety Inventory (STAI-S)
Time Frame: Baseline (1 day before surgery), day of surgery (pre-operation), 24 hours post-operation, and 72 hours post-operation.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Intensity as Measured by the Visual Analog Scale (VAS)
Time Frame: Baseline (1 day before surgery), day of surgery (pre-operation), 24 hours post-operation, and 72 hours post-operation.
Participants rate their pain on a 100 mm line (0 = no pain, 100 = worst possible pain). Higher scores reflect higher pain intensity.
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)
Time Frame: Baseline (1 day before surgery), day of surgery (pre-operation), 24 hours post-operation, and 72 hours post-operation.
Heart rate will be measured via a pulse oximeter to assess physiological stress response.
Baseline (1 day before surgery), day of surgery (pre-operation), 24 hours post-operation, and 72 hours post-operation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jia-Ling Wang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 114190-E (Other Grant/Funding Number: FarEasternMH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

a plan isn't set

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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