Virtual Reality and Its Use in Reducing Perioperative Stress in Cataract Surgery

NCT ID: NCT06822023

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-12
• Study Completion Date: 2025-12-01

Brief Summary

This project is to evaluate the benefits of utilising virtual reality (VR) headsets with the aim of reducing peri-operative anxiety in cataract surgery and hence reducing the need for sedation in patients with significant stress levels noted during preassessment. This is a novel study, and with the increased use of VR technology throughout medicine, we may be able to offer our patients alternative management modalities to reduce stress and reduce need for medications with their subsequent potential side effects. It may also improve the quality of care provided and patients' experience with the cataract extraction procedure and might reduce the social care burden associated with standard sedation procedures. All patients will need to fill a quick preoperative anxiety and information scale questionnaire to assess their level of anxiety utilising The Amsterdam Preoperative Anxiety and Information Score.

Patients will be randomised into 2 groups:

1. Conventional group: patients will be prepared as per the standard routine clinical and further explanation of the procedure will be given. Before proceeding to the anaesthetic room, the patients will complete the anxiety score questionnaire again and given the option to proceed with sedation or opt out.

2. Interventional Group: patients will be prepared as per the standard routine clinical care; they will then be wearing the VR mask for 10 minutes. Before proceeding to the anaesthetic room, patients will complete the anxiety score questionnaire again and given the option to proceed with sedation or opt out.

Post operation, a record will be taken of the surgeon's decision on whether they want the second eye cataract surgery to be done under sedation (this is already standard practice at our centre). Finally, the patient will be asked to fill in one final grading score on whether they are happy with their decision to take/not take sedation.

Conditions

Virtual Reality; Eye Disease; Cataract Surgery Anesthesia; Cataract Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional group

patients will be prepared as per the standard routine; clinical and further explanation of the procedure will be given. Before proceeding to the anaesthetic room, the patients will complete the anxiety score questionnaire again and given the option to proceed with sedation or opt out.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventional Group

patients will be prepared as per the standard routine clinical care; they will then be wearing the VR mask for 10 minutes. Before proceeding to the anaesthetic room, patients will complete the anxiety score questionnaire again and given the option to proceed with sedation or opt out

Group Type: EXPERIMENTAL

virtual reality mask

Intervention Type: DEVICE

Patients will be prepared as per the standard routine clinical care; they will then be wearing the VR mask for 10 minutes. No other study have looked into VR mask prior to cataract surgery

Interventions

virtual reality mask

Patients will be prepared as per the standard routine clinical care; they will then be wearing the VR mask for 10 minutes. No other study have looked into VR mask prior to cataract surgery

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients listed for cataract surgery under local anaesthetic (topical or regional) with sedation planned.

2. First eye cataract procedures will only be included.

3. Capacity to give informed consent, cognitive and linguistic ability sufficient to understand and fill out questionnaire

Exclusion Criteria

1. Epilepsy

2. severe vertigo

3. poor visual acuity (below 6/60 best corrected in the best seeing eye)

4. significant hearing impairment

5. recent facial injury/burn.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Tyneside and Sunderland NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jia Y Ng, MBChB, FRCOphth

Role: PRINCIPAL_INVESTIGATOR

south tyneside sunderland foundation trust

Central Contacts

Jia Y NG, MBChB, FHEA, FRCOphth

Role: CONTACT

jia.ng@nhs.net

+441915699954

Karen Davidson

Role: CONTACT

stsft.SEIResearchNurses@nhs.net

0191 565 6256 ext. 49074

References

Jacobi PC, Dietlein TS, Jacobi FK. A comparative study of topical vs retrobulbar anesthesia in complicated cataract surgery. Arch Ophthalmol. 2000 Aug;118(8):1037-43. doi: 10.1001/archopht.118.8.1037.

Reference Type: BACKGROUND

PMID: 10922195 (View on PubMed)

Related Links

https://www.lasereyesurgeryhub.co.uk/data/cataract-statistics/

Cataract Statistics \& Resources \[Internet\]

Other Identifiers

23/WS/0110

Identifier Type: -

Identifier Source: org_study_id