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

S

South Tyneside and Sunderland NHS Foundation Trust

Status

Not yet enrolling

Conditions

Cataract Surgery Anesthesia
Cataract Surgery
Eye Disease
Virtual Reality

Treatments

Device: virtual reality mask

Study type

Interventional

Funder types

Other

Identifiers

NCT06822023
23/WS/0110

Details and patient eligibility

About

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.

Enrollment

75 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 2 patient groups

Conventional group
No Intervention group
Description:
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 group
Description:
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
Treatment:
Device: virtual reality mask

Trial contacts and locations

0

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Central trial contact

Karen Davidson; Jia Y NG, MBChB, FHEA, FRCOphth

Data sourced from clinicaltrials.gov

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