Effects of VR on Preanesthetic Anxiety
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMackay Memorial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Psychiatric disorders.
Emergency surgery.
Visual or hearing impairment.
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality Intervention
BehavioralParticipants 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Virtual Reality Education GroupExperimental treatment 1 intervention
Group B: Standard Preoperative Education GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (before intervention) and Immediately after intervention2
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.
Time frame
Immediately after intervention and before anesthesia inductionSecondary outcomes
1
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.
Time frame
Baseline (before intervention) and Immediately after intervention2
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).
Time frame
Baseline (before intervention) and Immediately after intervention3
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).
Time frame
Baseline (before intervention) and Immediately after intervention4
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.
Time frame
Baseline (before intervention) and Immediately after interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mackay Memorial Hospital
Lead sponsor
Mackay Medical College
Collaborator
Source ClinicalTrials.gov
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