VR for Cataract Anxiety Lowering Management
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with cataracts in both eyes, and planning to undergo surgical treatment
Voluntarily participate in this trial and sign the informed consent form.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual reality simulation of intraoperative audiovisual experience
DeviceThis Virtual reality video simulates the audiovisual experience of phacoemulsification (Phaco and IOL) surgery
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: VR Intervention GroupExperimental treatment 1 intervention
Group B: Usual Care Group (No VR)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
HR
Heart rate at various intraoperative time points (before capsulorhexis, during phacoemulsification, and after intraocular lens implantation).
Time frame
collected during the surgery2
BP
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 surgery3
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 surgery4
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 surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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