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

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.

Study Overview

• Status: Completed
• Conditions: Cataract and IOL Surgery; VR-based Informed Consent
• Intervention / Treatment: Device: Virtual reality simulation of intraoperative audiovisual experience

• Study Type: Interventional
• Enrollment (Actual): 223
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200080
      • Shanghai General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR Intervention Group; 30 participants receive virtual reality simulation of intraoperative audiovisual experience before the surgery.	Device: Virtual reality simulation of intraoperative audiovisual experience; This Virtual reality video simulates the audiovisual experience of phacoemulsification (Phaco and IOL) surgery; Other Names: VR simulation; VR video
No Intervention: Usual Care Group (No VR); Participants with conventional preoperative instructions (no VR video)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of anxiety level evaluated by numerical rating scale (NRS)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of Heart Rate	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	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	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	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

Collaborators and Investigators

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2026
• Primary Completion (Actual): July 30, 2026
• Study Completion (Actual): July 30, 2026

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: August 1, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 2026KS258 (Other Identifier: Shanghai General Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No