Anxiety, Cholecystectomy, Laparoscopic, Perioperative Period, Uncertainty
Conditions
Keywords
Virtual Reality (VR), Preoperative Anxiety, General Anesthesia, Patient Education, Physiological Feedback
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.
Interventions
BEHAVIORALVirtual 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.
Sponsors
Mackay Memorial Hospital
Mackay Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative Anxiety-Amsterdam Preoperative Anxiety and Information Scale (APAIS) | Baseline (before intervention) and Immediately after intervention | 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. |
| Preoperative Anxiety Assessed by the Anxiety Visual Analogue Scale (VAS) | Immediately after intervention and before anesthesia induction | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative Uncertainty Assessed by the Uncertainty Visual Analogue Scale (VAS) | Baseline (before intervention) and Immediately after intervention | 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. |
| Preoperative Uncertainty Assessed by the Intolerance of Uncertainty Scale (IUS-12) | Baseline (before intervention) and Immediately after intervention | 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). |
| Neurofeedback Indicator: Low-Frequency Electroencephalogram (EEG) Activation Level Assessed by the ProComp Infiniti System | Baseline (before intervention) and Immediately after intervention | 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). |
| Autonomic Neurofeedback Indicator: Heart Rate Variability (HRV) Assessed by the ProComp Infiniti System | Baseline (before intervention) and Immediately after intervention | 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. |
| Acceptance of Virtual Reality Technology Assessed by the Chinese Version of the Technology Acceptance Model (TAM) Scale | Baseline (before intervention) and Immediately after intervention | 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). |
| Participant Satisfaction Assessed by the Patient Satisfaction Scale | Immediately after intervention | 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 |
Countries
Taiwan
Contacts
CONTACTShu Fen Shen, Ph.D
Outcome results
None listed