VR for Cataract Anxiety Lowering Management (VR-CALM)
A Non-Randomized Controlled Trial of Virtual Reality Simulation of Intraoperative Audiovisual Experience to Reduce Anxiety in Cataract Surgery Patients
Cataract is currently the leading cause of blindness globally, and surgery is the only effective treatment. With the advancement of medical technology, cataract surgery is usually performed under topical anesthesia, which means patients will be awake during the procedure, able to see the light from the surgical lamp and hear the sounds of surgical instruments being operated. Some patients may feel nervous or scared due to unfamiliarity with the surgical process, which may lead to increased blood pressure, rapid heartbeat, and even affect their cooperation during the surgery.
Virtual reality (VR) technology is a new multimedia technology. By wearing VR glasses, patients can immerse themselves in a virtual world and see and hear realistic scenes. Through this study, the investigators aim to investigate whether allowing cataract patients to "experience" a surgical procedure in advance through VR glasses before cataract surgery can help alleviate their nervousness during the actual surgery.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200080
- Shanghai General Hospital
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Diagnosed with cataracts in both eyes, and planning to undergo surgical treatment
- Voluntarily participate in this trial and sign the informed consent form.
Exclusion Criteria:
- Having any history of previous ophthalmic surgery.
- Suffering from severe hearing impairment, unable to comprehend VR video content.
- Those who suffer from cognitive dysfunction or mental illness and are unable to cooperate in completing the scale assessment.
- Suffering from severe macular diseases, glaucoma, or other ocular diseases that may affect surgery or interfere with the assessment of tension level.
- Assessed as intolerant to surface anesthesia surgery.
- History of motion sickness, severe vertigo, or intolerance to VR video viewing (such as claustrophobia).
- Other situations where the researcher deems the participant unsuitable for participation in this study.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: VR Intervention Group
30 participants receive VR simulation of intraoperative audiovisual experience before the surgery.
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This Virtual reality video simulates the audiovisual experience of phacoemulsification (Phaco and IOL) surgery
Andra namn:
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Inget ingripande: Usual Care Group (No VR)
Participants with conventional preoperative instructions (no VR)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Intraoperative anxiety numerical rating scale (NRS)
Tidsram: collected immediately after the surgery
|
Intraoperative participants self-reported anxiety level using numerical rating scale (NRS), from 0 (no anxiety) to 10 (highest anxiety)
|
collected immediately after the surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain Numerical Rating Scale (NRS)
Tidsram: collected immediately after the surgery
|
Intraoperative participants self-reported pain level using numerical rating scale (NRS), from 0 (no pain) to 10 (highest pain)
|
collected immediately after the surgery
|
|
Cooperation Numerical Rating Scale (NRS)
Tidsram: collected immediately after the surgery
|
The numerical rating scale (NRS) score of patient cooperation level assessed by the surgeon, from 0 (very bad cooperation) to 5 (very good cooperation)
|
collected immediately after the surgery
|
|
Heart rate
Tidsram: collected during the surgery
|
Heart rate at various intraoperative time points (before capsulorhexis, during phacoemulsification, and after intraocular lens implantation).
|
collected during the surgery
|
|
Blood Pressure
Tidsram: collected during the surgery
|
Systolic blood pressure and diastolic blood pressure at various intraoperative time points (before capsulorhexis, during phacoemulsification, and after intraocular lens implantation).
|
collected during the surgery
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20260405104228660
- 2026KS258 (Annan identifierare: Shanghai General Hospital)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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