VR-based Informed ConsentVR-CALMNCT07586280
VR for Cataract Anxiety Lowering Management
A study testing Virtual reality simulation of intraoperative audiovisual experience in people with VR-based Informed Consent and Cataract and Intraocular Lens Surgery, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- VR-based Informed Consent, Cataract and Intraocular Lens Surgery
- What is being tested?
- Virtual reality simulation of intraoperative audiovisual experience
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with cataracts in both eyes, and planning to undergo surgical treatment
- Voluntarily participate in this trial and sign the informed consent form.
Who cannot join
- 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.
- Assessed as intolerant to surface anesthesia surgery.
- History of motion sickness, severe vertigo, or intolerance to VR video viewing (such as claustrophobia).
- Other situations where the researcher deems the participant unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-Randomized Controlled Trial 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.
- Being tested
- Virtual reality simulation of intraoperative audiovisual experience
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality simulation of intraoperative audiovisual experienceDevice
Also called VR simulation, VR video
This Virtual reality video simulates the audiovisual experience of phacoemulsification (Phaco and IOL) surgery
| Study group | Role | What they receive |
|---|---|---|
| VR Intervention Group | Experimental | 30 participants receive VR simulation of intraoperative audiovisual experience before the surgery. Receives: Device: Virtual reality simulation of intraoperative audiovisual experience |
| Usual Care Group (No VR) | No intervention | Participants with conventional preoperative instructions (no VR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: collected immediately after the surgery
Secondary outcomes (4)
Heart rate
Heart rate at various intraoperative time points (before capsulorhexis, during phacoemulsification, and after intraocular lens implantation).
Measured: collected during the surgery
Blood Pressure
Systolic blood pressure and diastolic blood pressure at various intraoperative time points (before capsulorhexis, during phacoemulsification, and after intraocular lens implantation).
Measured: 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)
Measured: 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)
Measured: collected immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 May 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VR-based Informed ConsentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peiyao Jin, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586280
- Sponsor's protocol ID
- 20260405104228660
- Other IDs
- 2026KS258
- Acronym
- VR-CALM
- Status last verified
- Aug 2026
- First submitted
- 6 May 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized Controlled Trial of Virtual Reality Simulation of Intraoperative Audiovisual Experience to Reduce Anxiety in Cataract Surgery Patients
- ClinicalTrials.gov ID
- NCT07586280
- Acronym / sponsor ID
- VR-CALM / 20260405104228660
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR Intervention Group | Experimental | Device: Virtual reality simulation of intraoperative audiovisual experience30 participants receive VR simulation of intraoperative audiovisual experience before the surgery. |
| Usual Care Group (No VR) | No intervention | –Participants with conventional preoperative instructions (no VR) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with cataracts in both eyes, and planning to undergo surgical treatment
- Voluntarily participate in this trial and sign the informed consent form.
Key exclusion criteria (7 listed)
- 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.
- Assessed as intolerant to surface anesthesia surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality simulation of intraoperative audiovisual experienceAlso: VR simulation, VR videoThis Virtual reality video simulates the audiovisual experience of phacoemulsification (Phaco and IOL) surgery | Device | VR Intervention Group |
Primary outcome
Intraoperative anxiety numerical rating scale (NRS)
Time frame: collected immediately after the surgery
Intraoperative participants self-reported anxiety level using numerical rating scale (NRS), from 0 (no anxiety) to 10 (highest anxiety)
4 secondary outcomes
Heart rate
Time frame: collected during the surgery
Blood Pressure
Time frame: collected during the surgery
Pain Numerical Rating Scale (NRS)
Time frame: collected immediately after the surgery
Cooperation Numerical Rating Scale (NRS)
Time frame: collected immediately after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality simulation of intraoperative audiovisual experience in people with VR-based Informed Consent and Cataract and Intraocular Lens Surgery, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative anxiety numerical rating scale (NRS) (time frame: collected immediately after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.