- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07656246
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
Les conditions
Intervention / Traitement
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
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New Taipei City, Taïwan
- MacKay Memorial Hospital, Tamsui Branch
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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 |
|---|---|
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Expérimental: Virtual Reality Education Group
Participants receive a virtual reality-based preoperative educational intervention before general anesthesia.
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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.
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Aucune intervention: Standard Preoperative Education Group
Participants receive standard printed preoperative education materials before general anesthesia.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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.
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Baseline (before intervention) and Immediately after intervention
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Preoperative Anxiety Assessed by the Anxiety Visual Analogue Scale (VAS)
Délai: Immediately after intervention and before anesthesia induction
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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.
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Immediately after intervention and before anesthesia induction
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Preoperative Uncertainty Assessed by the Uncertainty Visual Analogue Scale (VAS)
Délai: Baseline (before intervention) and Immediately after intervention
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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.
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Baseline (before intervention) and Immediately after intervention
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Preoperative Uncertainty Assessed by the Intolerance of Uncertainty Scale (IUS-12)
Délai: Baseline (before intervention) and Immediately after intervention
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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
|
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Neurofeedback Indicator: Low-Frequency Electroencephalogram (EEG) Activation Level Assessed by the ProComp Infiniti System
Délai: Baseline (before intervention) and Immediately after intervention
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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).
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Baseline (before intervention) and Immediately after intervention
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Autonomic Neurofeedback Indicator: Heart Rate Variability (HRV) Assessed by the ProComp Infiniti System
Délai: Baseline (before intervention) and Immediately after intervention
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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.
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Baseline (before intervention) and Immediately after intervention
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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
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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).
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Baseline (before intervention) and Immediately after intervention
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Participant Satisfaction Assessed by the Patient Satisfaction Scale
Délai: Immediately after intervention
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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
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Immediately after intervention
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
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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