- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07656246
Effects of VR on Preanesthetic Anxiety
14. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
200
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Shu Fen Shen, Ph.D
- Telefonnummer: 1312 +886-2-2636-0300
- E-Mail: shufen@mmu.edu.tw
Studienorte
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New Taipei City, Taiwan
- MacKay Memorial Hospital, Tamsui Branch
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Kontakt:
- Shu Fen Shen, Ph.D
- Telefonnummer: 1312 +886-2-2636-0300
- E-Mail: shufen@mmu.edu.tw
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Kein Eingriff: Standard Preoperative Education Group
Participants receive standard printed preoperative education materials before general anesthesia.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Preoperative Anxiety-Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Zeitfenster: 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)
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Preoperative Uncertainty Assessed by the Uncertainty Visual Analogue Scale (VAS)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
9. Juni 2026
Primärer Abschluss (Geschätzt)
31. Dezember 2027
Studienabschluss (Geschätzt)
31. Dezember 2028
Studienanmeldedaten
Zuerst eingereicht
9. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
14. Juni 2026
Zuerst gepostet (Tatsächlich)
18. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
18. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
14. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 25MMHIS300e
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
Individual participant data will not be made available because the informed consent obtained from participants did not include permission for public data sharing.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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