Effects of VR on Preanesthetic Anxiety

Effects of Virtual Reality Intervention on Anxiety and Uncertainty Before General Anesthesia Among Patients Undergoing Laparoscopic Cholecystectomy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Uncertainty; VR; Preanesthetic Anxiety
• Intervention / Treatment: Behavioral: Virtual Reality Intervention

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shu Fen Shen, Ph.D; Phone Number: 1312 +886-2-2636-0300; Email: shufen@mmu.edu.tw

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • MacKay Memorial Hospital, Tamsui Branch
    • Contact: Shu Fen Shen, Ph.D; Phone Number: 1312 +886-2-2636-0300; Email: shufen@mmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Education Group; Participants receive a virtual reality-based preoperative educational intervention before general anesthesia.	Behavioral: Virtual Reality Intervention; 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.
No Intervention: Standard Preoperative Education Group; Participants receive standard printed preoperative education materials before general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative Uncertainty Assessed by the Uncertainty Visual Analogue Scale (VAS)	The Uncertainty Visual Analogue Scale (VAS) is a self-reported tool used to measure the intensity of preoperative uncertainty. Scores range from 0 (no uncertainty) to 100 (extreme uncertainty), where higher scores indicate a higher level of preoperative uncertainty.	Baseline (before intervention) and Immediately after intervention
Preoperative Uncertainty Assessed by the Intolerance of Uncertainty Scale (IUS-12)	IUS-12 will be used to assess the participant's emotional, cognitive, and behavioral reactions to ambiguous situations. The IUS-12 consists of 12 items with a total score ranging from 12 to 60), where higher scores indicate a lower tolerance for uncertainty (a worse outcome).	Baseline (before intervention) and Immediately after intervention
Neurofeedback Indicator: Low-Frequency Electroencephalogram (EEG) Activation Level Assessed by the ProComp Infiniti System	The ProComp Infiniti System (Thought Technology Ltd., distributed by Bio-Medical Instruments) will be used to measure the activation level of low-frequency electroencephalogram (EEG) waves. An increase in the measured value indicates a higher level of activation of low-frequency brainwaves, which represents an increase in the participant's stress and anxiety levels (a worse outcome).	Baseline (before intervention) and Immediately after intervention
Autonomic Neurofeedback Indicator: Heart Rate Variability (HRV) Assessed by the ProComp Infiniti System	The ProComp Infiniti System will be used to measure heart rate variability (HRV) indicators. Higher HRV values generally represent better autonomic nervous system flexibility and superior stress regulation (a better outcome). Conversely, lower HRV values are associated with higher levels of stress and anxiety.	Baseline (before intervention) and Immediately after intervention
Acceptance of Virtual Reality Technology Assessed by the Chinese Version of the Technology Acceptance Model (TAM) Scale	The Chinese version of the Technology Acceptance Model (TAM) scale will be used to evaluate the participants' acceptance of virtual reality technology. The total score ranges from 11 to 33, with higher scores indicating a higher level of patient acceptance toward virtual reality technology. This assessment includes dimensions such as behavioral intention to use, perceived usefulness (believing it is helpful), and perceived ease of use (finding operations simple and convenient).	Baseline (before intervention) and Immediately after intervention
Participant Satisfaction Assessed by the Patient Satisfaction Scale	Patient Satisfaction Scale will be used to assess the participants' level of satisfaction with the intervention. The total score ranges from 10 to 50, where a higher score indicates a higher level of satisfaction with the program	Immediately after intervention

Collaborators and Investigators

• Sponsor: Mackay Memorial Hospital
• Collaborators: Mackay Medical College

Study record dates

Study Major Dates

• Study Start (Estimated): June 9, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 14, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 14, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 25MMHIS300e

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made available because the informed consent obtained from participants did not include permission for public data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No