- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07656246
Effects of VR on Preanesthetic Anxiety
14. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
200
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Shu Fen Shen, Ph.D
- Telefonnummer: 1312 +886-2-2636-0300
- E-post: shufen@mmu.edu.tw
Studiesteder
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New Taipei City, Taiwan
- MacKay Memorial Hospital, Tamsui Branch
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Ta kontakt med:
- Shu Fen Shen, Ph.D
- Telefonnummer: 1312 +886-2-2636-0300
- E-post: shufen@mmu.edu.tw
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Ingen inngripen: Standard Preoperative Education Group
Participants receive standard printed preoperative education materials before general anesthesia.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Preoperative Anxiety-Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Preoperative Uncertainty Assessed by the Uncertainty Visual Analogue Scale (VAS)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
9. juni 2026
Primær fullføring (Antatt)
31. desember 2027
Studiet fullført (Antatt)
31. desember 2028
Datoer for studieregistrering
Først innsendt
9. juni 2026
Først innsendt som oppfylte QC-kriteriene
14. juni 2026
Først lagt ut (Faktiske)
18. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 25MMHIS300e
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Individual participant data will not be made available because the informed consent obtained from participants did not include permission for public data sharing.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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