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

NCT06822023 | Not Yet Recruiting

• 1 other identifier: 23/WS/0110
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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. 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. 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.

Conditions

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

Keywords

cataract surgery, sedation, anxiety, virtual reality

Outcome Measures

Primary Outcomes (1)

• Anxiety score

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

  10 mins following intervention

Secondary Outcomes (2)

• Patient required sedation after intervention

  10 mins

• Patient required sedation for second eye surgery

  Following surgery, approximately 30-60 mins following intervention

Study Arms (2)

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

Device: virtual reality mask

Interventions

virtual reality mask 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

Interventional Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• South Tyneside and Sunderland NHS Foundation Trust: lead

Related Publications (1)

• 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.

  PMID: 10922195 BACKGROUND

Related Links

• Cataract Statistics \& Resources \[Internet\]

MeSH Terms

Conditions

Eye Diseases; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jia Y Ng, MBChB, FRCOphth

  south tyneside sunderland foundation trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia Y NG, MBChB, FHEA, FRCOphth

CONTACT

+441915699954; jia.ng@nhs.net

Karen Davidson

CONTACT

0191 565 6256; stsft.SEIResearchNurses@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised control trial

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 12, 2025
• Study Start: February 12, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02