- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07656246
Effects of VR on Preanesthetic Anxiety
14 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
200
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Shu Fen Shen, Ph.D
- Numero di telefono: 1312 +886-2-2636-0300
- Email: shufen@mmu.edu.tw
Luoghi di studio
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New Taipei City, Taiwan
- MacKay Memorial Hospital, Tamsui Branch
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Contatto:
- Shu Fen Shen, Ph.D
- Numero di telefono: 1312 +886-2-2636-0300
- Email: shufen@mmu.edu.tw
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Nessun intervento: Standard Preoperative Education Group
Participants receive standard printed preoperative education materials before general anesthesia.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Preoperative Anxiety-Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Lasso di tempo: Baseline (before intervention) and Immediately after intervention
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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)
Lasso di tempo: 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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Preoperative Uncertainty Assessed by the Uncertainty Visual Analogue Scale (VAS)
Lasso di tempo: 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)
Lasso di tempo: 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).
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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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
9 giugno 2026
Completamento primario (Stimato)
31 dicembre 2027
Completamento dello studio (Stimato)
31 dicembre 2028
Date di iscrizione allo studio
Primo inviato
9 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
14 giugno 2026
Primo Inserito (Effettivo)
18 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
18 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 25MMHIS300e
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
Individual participant data will not be made available because the informed consent obtained from participants did not include permission for public data sharing.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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