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Effects of VR on Preanesthetic Anxiety

14 juin 2026 mis à jour par: Mackay Memorial Hospital

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Type d'étude

Interventionnel

Inscription (Estimé)

200

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Shu Fen Shen, Ph.D
  • Numéro de téléphone: 1312 +886-2-2636-0300
  • E-mail: shufen@mmu.edu.tw

Lieux d'étude

      • New Taipei City, Taïwan
        • MacKay Memorial Hospital, Tamsui Branch
        • Contact:
          • Shu Fen Shen, Ph.D
          • Numéro de téléphone: 1312 +886-2-2636-0300
          • E-mail: shufen@mmu.edu.tw

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Virtual Reality Education Group
Participants receive a virtual reality-based preoperative educational intervention before general anesthesia.
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.
Aucune intervention: Standard Preoperative Education Group
Participants receive standard printed preoperative education materials before general anesthesia.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Preoperative Anxiety-Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Délai: 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.
Baseline (before intervention) and Immediately after intervention
Preoperative Anxiety Assessed by the Anxiety Visual Analogue Scale (VAS)
Délai: 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.
Immediately after intervention and before anesthesia induction

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Preoperative Uncertainty Assessed by the Uncertainty Visual Analogue Scale (VAS)
Délai: 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.
Baseline (before intervention) and Immediately after intervention
Preoperative Uncertainty Assessed by the Intolerance of Uncertainty Scale (IUS-12)
Délai: 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).
Baseline (before intervention) and Immediately after intervention
Neurofeedback Indicator: Low-Frequency Electroencephalogram (EEG) Activation Level Assessed by the ProComp Infiniti System
Délai: 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).
Baseline (before intervention) and Immediately after intervention
Autonomic Neurofeedback Indicator: Heart Rate Variability (HRV) Assessed by the ProComp Infiniti System
Délai: 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.
Baseline (before intervention) and Immediately after intervention
Acceptance of Virtual Reality Technology Assessed by the Chinese Version of the Technology Acceptance Model (TAM) Scale
Délai: 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).
Baseline (before intervention) and Immediately after intervention
Participant Satisfaction Assessed by the Patient Satisfaction Scale
Délai: 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
Immediately after intervention

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

9 juin 2026

Achèvement primaire (Estimé)

31 décembre 2027

Achèvement de l'étude (Estimé)

31 décembre 2028

Dates d'inscription aux études

Première soumission

9 juin 2026

Première soumission répondant aux critères de contrôle qualité

14 juin 2026

Première publication (Réel)

18 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 25MMHIS300e

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data will not be made available because the informed consent obtained from participants did not include permission for public data sharing.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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