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Not yet recruiting NCT07656246

Effects of VR on Preanesthetic Anxiety

No phase Interventional Cholecystectomy, Laparoscopic Anxiety Uncertainty Perioperative Period

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality Intervention.
Who it may be relevant to
Registry conditions: Cholecystectomy, Laparoscopic, Anxiety, Uncertainty, Perioperative Period. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Preoperative Anxiety-Amsterdam Preoperative Anxiety and Information Scale (APAIS) [Time frame: Baseline (before intervention) and Immediately after intervention]
  • Preoperative Anxiety Assessed by the Anxiety Visual Analogue Scale (VAS) [Time frame: Immediately after intervention and before anesthesia induction]
Secondary outcome measures (6)
  • Preoperative Uncertainty Assessed by the Uncertainty Visual Analogue Scale (VAS) [Time frame: Baseline (before intervention) and Immediately after intervention]
  • Preoperative Uncertainty Assessed by the Intolerance of Uncertainty Scale (IUS-12) [Time frame: Baseline (before intervention) and Immediately after intervention]
  • Neurofeedback Indicator: Low-Frequency Electroencephalogram (EEG) Activation Level Assessed by the ProComp Infiniti System [Time frame: Baseline (before intervention) and Immediately after intervention]
  • Autonomic Neurofeedback Indicator: Heart Rate Variability (HRV) Assessed by the ProComp Infiniti System [Time frame: Baseline (before intervention) and Immediately after intervention]
  • Acceptance of Virtual Reality Technology Assessed by the Chinese Version of the Technology Acceptance Model (TAM) Scale [Time frame: Baseline (before intervention) and Immediately after intervention]
  • Participant Satisfaction Assessed by the Patient Satisfaction Scale [Time frame: Immediately after intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Taiwan · 1 center
  • MacKay Memorial Hospital, Tamsui Branch — New Taipei City

Identifiers

NCT: NCT07656246 · 25MMHIS300e

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗