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NCT Number: NCT06822023

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

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

Primary outcomes

  1. 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

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jia Y NG, MBChB, FHEA, FRCOphth

CONTACT

[email protected]

+441915699954

Karen Davidson

CONTACT

[email protected]

0191 565 6256 ext. 49074

Sponsors and collaborators

Lead sponsor

South Tyneside and Sunderland NHS Foundation Trust

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2025
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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