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Clinical Trials/NCT06822023
NCT06822023Not yet recruitingNot Applicable

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

South Tyneside and Sunderland NHS Foundation Trust0 sites75 target enrollmentStarted: February 12, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
75
Primary Endpoint
Anxiety score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients listed for cataract surgery under local anaesthetic (topical or regional) with sedation planned.
  • •First eye cataract procedures will only be included.
  • •Capacity to give informed consent, cognitive and linguistic ability sufficient to understand and fill out questionnaire

Exclusion Criteria

  • •severe vertigo
  • •poor visual acuity (below 6/60 best corrected in the best seeing eye)
  • •significant hearing impairment
  • •recent facial injury/burn.

Arms & Interventions

Conventional group

No Intervention

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.

Interventional Group

Experimental

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

Intervention: virtual reality mask (Device)

Outcomes

Primary Outcomes

Anxiety score

Time Frame: 10 mins following intervention

Percentage of reduction in Anxiety score in interventional group as compared to control group as assessed using the Amsterdam preoperative anxiety and information score

Secondary Outcomes

  • Patient required sedation after intervention(10 mins)
  • Patient required sedation for second eye surgery(Following surgery, approximately 30-60 mins following intervention)

Investigators

Sponsor
South Tyneside and Sunderland NHS Foundation Trust
Sponsor Class
Other
Responsible Party
Sponsor

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