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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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 c

Первичные конечные точки

• Change From Baseline in Anxiety Scores on the State-Trait Anxiety Inventory (STAI-S) [Срок оценки: Baseline (1 day before surgery), day of surgery (pre-operation), 24 hours post-operation, and 72 hours post-operation.]

Вторичные конечные точки (2)

• Postoperative Pain Intensity as Measured by the Visual Analog Scale (VAS) [Срок оценки: 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) [Срок оценки: Baseline (1 day before surgery), day of surgery (pre-operation), 24 hours post-operation, and 72 hours post-operation.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT07483866 · 114190-E · 114190-E

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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