Effects of VR on Preanesthetic Anxiety

NCT07656246 | Not Yet Recruiting

• 1 other identifier: 25MMHIS300e
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

In today's medical environment, laparoscopic cholecystectomy is a common procedure for treating gallbladder diseases, offering advantages such as smaller incisions and faster recovery. However, patients often experience significant preoperative anxiety and uncertainty when facing general anesthesia. This is mainly due to unfamiliarity with the anesthesia process, concerns about potential risks, and uncertainty regarding the overall experience. Excessive anxiety and uncertainty can not only affect the patient's emotional stability and cooperation but may also prolong postoperative recovery time and negatively impact the overall quality of medical care. Virtual Reality (VR) is an emerging innovative technology characterized by its immersive, interactive, and highly realistic features. It has been widely applied in fields such as education, psychotherapy, and healthcare education. By simulating the surgical environment and anesthesia process through VR technology, patients can gain visual and psychological adaptation before undergoing anesthesia. This helps enhance their understanding and sense of control over the medical procedure, thereby reducing feelings of unease and anxiety. The purpose of this study is to explore the effects of a virtual reality (VR) intervention on preoperative anxiety and uncertainty in patients undergoing laparoscopic cholecystectomy under general anesthesia. This experimental study recruited a total of 142 patients scheduled for surgery at a medical center, who were randomly assigned to either the experimental group or the control group. Patients in the experimental group, in addition to receiving standard printed preoperative education materials, experienced a VR video the day before surgery. The video introduced the operating room environment and anesthesia procedures. The control group received only the printed educational materials. Research instruments included measures of anxiety (Amsterdam Preoperative Anxiety and Information Scale \[APAIS\], Anxiety Visual Analogue Scale \[VAS\]), uncertainty (Uncertainty Visual Analogue Scale, Intolerance of Uncertainty Scale), and neuro-autonomic feedback indicators. Assessments were conducted before and after the intervention to evaluate its effectiveness. This study anticipates that the virtual reality (VR) intervention will effectively reduce patients' pre-anesthesia anxiety and uncertainty, thereby enhancing their adaptation to the general anesthesia process and improving psychological stability. The findings may provide clinical anesthesia nursing staff with evidence-based support for incorporating emerging technologies into pre-anesthesia education. Furthermore, the results can serve as a reference for developing diversified patient education models in the future.

Conditions

Uncertainty; Anxiety; Perioperative Period; Cholecystectomy, Laparoscopic

Keywords

Virtual Reality (VR); Preoperative Anxiety; General Anesthesia; Patient Education; Physiological Feedback

Outcome Measures

Primary Outcomes (2)

• Preoperative Anxiety-Amsterdam Preoperative Anxiety and Information Scale (APAIS)

  APAIS will be used to measure preoperative anxiety. Total anxiety scores range from 4 to 20, where higher scores indicate a higher level of preoperative anxiety.

  Baseline (before intervention) and Immediately after intervention

• Preoperative Anxiety Assessed by the Anxiety Visual Analogue Scale (VAS)

  VAS is a self-reported scale consisting of a horizontal line. Scores range from 0 (no anxiety) to 10 (extreme anxiety), where higher scores indicate a higher level of anxiety.

  Immediately after intervention and before anesthesia induction

Secondary Outcomes (6)

• Preoperative Uncertainty Assessed by the Uncertainty Visual Analogue Scale (VAS)

  Baseline (before intervention) and Immediately after intervention

• Preoperative Uncertainty Assessed by the Intolerance of Uncertainty Scale (IUS-12)

  Baseline (before intervention) and Immediately after intervention

• Neurofeedback Indicator: Low-Frequency Electroencephalogram (EEG) Activation Level Assessed by the ProComp Infiniti System

  Baseline (before intervention) and Immediately after intervention

• Autonomic Neurofeedback Indicator: Heart Rate Variability (HRV) Assessed by the ProComp Infiniti System

  Baseline (before intervention) and Immediately after intervention

• Acceptance of Virtual Reality Technology Assessed by the Chinese Version of the Technology Acceptance Model (TAM) Scale

  Baseline (before intervention) and Immediately after intervention

Study Arms (2)

Virtual Reality Education Group

EXPERIMENTAL

Participants receive a virtual reality-based preoperative educational intervention before general anesthesia.

Behavioral: Virtual Reality Intervention

Standard Preoperative Education Group

NO INTERVENTION

Participants receive standard printed preoperative education materials before general anesthesia.

Interventions

Virtual Reality Intervention BEHAVIORAL

Participants receive a single session of virtual reality-based preoperative education before undergoing laparoscopic cholecystectomy under general anesthesia. The virtual reality program presents information about the surgical procedure, operating room environment, anesthesia induction and recovery process through immersive audiovisual content. The intervention is designed to improve patient understanding and reduce preoperative anxiety and uncertainty.

Virtual Reality Education Group

Eligibility Criteria

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

You may qualify if:

• Aged 18 years or older.
• Able to communicate in Mandarin Chinese or Taiwanese and complete questionnaires.
• ASA Physical Status I-II.
• Hospitalized one day before surgery.
• No previous experience with general anesthesia.
• Scheduled for laparoscopic cholecystectomy under general anesthesia with endotracheal intubation.

You may not qualify if:

• Psychiatric disorders.
• Emergency surgery.
• Visual or hearing impairment.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead
• Mackay Medical College: collaborator

Study Sites (1)

MacKay Memorial Hospital, Tamsui Branch

New Taipei City, Taiwan

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Shu Fen Shen, Ph.D

CONTACT

+886-2-2636-0300; shufen@mmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 18, 2026
• Study Start: June 9, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)