VR for Cataract Anxiety Lowering Management--A RCT Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-90
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 one or both eyes, and planning to undergo surgical treatment
Voluntarily participate in this trial and sign the informed consent form.
Disqualifiers
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
260 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
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)
Time frame
collected before the intervention (VR video or conventional preoperative instructions) , immediately before the surgery, and immediately after the surgerySecondary outcomes
1
The change of Heart Rate
The change of heart rates before and during the surgery
Time frame
Before the intervention (VR video or conventional preoperative instructions) , immediately before the surgery, and during phacoemulsification.2
The change of blood pressure
The change of blood pressure before and during the surgery
Time frame
collected before the intervention (VR video or conventional preoperative instructions) , immediately before the surgery, and during phacoemulsification3
Pain level
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
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)
Time frame
collected immediately after the surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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