Clinical trial NCT06822023: Virtual Reality and Its Use in Reducing Perioperative Stress in Cataract Surgery
Official title: Virtual Reality and Its Use in Reducing Perioperative Stress in Cataract Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Virtual Reality
Eye Disease
Cataract Surgery Anesthesia
Cataract Surgery
Keywords: cataract surgery, sedation, anxiety, virtual reality
Lead sponsor: South Tyneside and Sunderland NHS Foundation Trust
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised control trial
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Anxiety score
timeFrame: 10 mins following intervention
Secondary outcomes:
measure: Patient required sedation after intervention
timeFrame: 10 mins
measure: Patient required sedation for second eye surgery
timeFrame: Following surgery, approximately 30-60 mins following intervention
Other outcomes:
Locations:
Study officials:
affiliation: south tyneside sunderland foundation trust
name: Jia Y Ng, MBChB, FRCOphth
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.