VR for Cataract Anxiety Lowering Management

N/ANot Yet RecruitingNCT07586280

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

VR-based Informed Consent Cataract and IOL Surgery

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosed with cataracts in both eyes, and planning to undergo surgical treatment 2. Voluntarily participate in this trial and sign the informed consent form. Exclusion Criteria: 1. Having any 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 surface anesthesia 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.

Outcomes

Primary Outcomes

Intraoperative anxiety numerical rating scale (NRS)

Intraoperative participants self-reported anxiety level using numerical rating scale (NRS), from 0 (no anxiety) to 10 (highest anxiety)

Time frame: collected immediately after the surgery

Secondary Outcomes

Heart rate at various intraoperative time points (before capsulorhexis, during phacoemulsification, and after intraocular lens implantation).

Time frame: 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).

Time frame: collected during the surgery

Pain Numerical Rating Scale (NRS)

Intraoperative participants self-reported pain level using numerical rating scale (NRS), from 0 (no pain) to 10 (highest pain)

Time frame: collected immediately after the surgery

Cooperation Numerical Rating Scale (NRS)

The numerical rating scale (NRS) score of patient cooperation level assessed by the surgeon, from 0 (very bad cooperation) to 5 (very good cooperation)

Time frame: collected immediately after the surgery

VR for Cataract Anxiety Lowering Management

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts