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

February 6, 2025 updated by: South Tyneside and Sunderland NHS Foundation Trust

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jia Y NG, MBChB, FHEA, FRCOphth
  • Phone Number: +441915699954
  • Email: jia.ng@nhs.net

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 mins following intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient required sedation after intervention
Time Frame: 10 mins
Percentage of patients who were happy with their decision to undergo/not undergo sedation in intervention vs control group.
10 mins
Patient required sedation for second eye surgery
Time Frame: Following surgery, approximately 30-60 mins following intervention
Percentage of patients who the surgeons would list their second eye for sedation in intervention vs control group.
Following surgery, approximately 30-60 mins following intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Tyneside and Sunderland NHS Foundation Trust

Investigators

  • Principal Investigator: Jia Y Ng, MBChB, FRCOphth, south tyneside sunderland foundation trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 12, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23/WS/0110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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