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NCT Number: NCT07483866

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Other names: VR Education

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jia Ling WANG

CONTACT

[email protected]

886+0938562061

Sponsors and collaborators

Lead sponsor

Jia-Ling Wang

Other

Registry information

Acronym: VR

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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