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VR for Cataract Anxiety Lowering Management--A RCT Study (VR-CALM)

1. august 2026 opdateret af: Peiyao Jin, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

A Randomized Controlled Study 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

223

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200080
        • Shanghai General Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Diagnosed with cataracts in one or both eyes, and planning to undergo surgical treatment
  2. Voluntarily participate in this trial and sign the informed consent form.

Exclusion Criteria:

  1. History of previous ophthalmic surgery
  2. Suffering from severe hearing impairment, unable to comprehend VR video content.
  3. Those who suffer from cognitive dysfunction or mental illness and are unable to cooperate in completing the scale assessment.
  4. Suffering from severe macular diseases, glaucoma, or other ocular diseases that may affect surgery or interfere with the assessment of tension level.
  5. Assessed as intolerant to topical anesthesia for the surgery.
  6. History of motion sickness, severe vertigo, or intolerance to VR video viewing (such as claustrophobia).
  7. Other situations where the researcher deems the participant unsuitable for participation in this study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: VR Intervention Group
30 participants receive virtual reality simulation of intraoperative audiovisual experience before the surgery.
Enhed: Virtual reality simulation of intraoperative audiovisual experience
This Virtual reality video simulates the audiovisual experience of phacoemulsification (Phaco and IOL) surgery
Andre navne:
  • VR simulation
  • VR video
Ingen indgriben: Usual Care Group (No VR)
Participants with conventional preoperative instructions (no VR video)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The change of anxiety level evaluated by numerical rating scale (NRS)
Tidsramme: collected before the intervention (VR video or conventional preoperative instructions) , immediately before the surgery, and immediately after the surgery
The change of participants self-reported anxiety levels before and during the surgery, evaluated by numerical rating scale (NRS), from 0 (no anxiety) to 10 (highest anxiety)
collected before the intervention (VR video or conventional preoperative instructions) , immediately before the surgery, and immediately after the surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The change of Heart Rate
Tidsramme: Before the intervention (VR video or conventional preoperative instructions) , immediately before the surgery, and during phacoemulsification.
The change of heart rates before and during the surgery
Before the intervention (VR video or conventional preoperative instructions) , immediately before the surgery, and during phacoemulsification.
The change of blood pressure
Tidsramme: collected before the intervention (VR video or conventional preoperative instructions) , immediately before the surgery, and during phacoemulsification
The change of blood pressure before and during the surgery
collected before the intervention (VR video or conventional preoperative instructions) , immediately before the surgery, and during phacoemulsification
Pain level
Tidsramme: 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
Patients' cooperation level
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2026

Primær færdiggørelse (Faktiske)

30. juli 2026

Studieafslutning (Faktiske)

30. juli 2026

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

27. maj 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026KS258 (Anden identifikator: Shanghai General Hospital)

Plan for individuelle deltagerdata (IPD)

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