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Completed

NCT Number: NCT05564013

Developing a Virtual Reality (VR)-Based Prototype for Perioperative Care - a Proof of Concept Study

Preoperative anxiety and acute post-operative pain are common and have been associated with the development of chronic post-surgical pain and longer hospitalisation. Pharmacological interventions to combat anxiety and pain come with their attendant adverse effects. Therefore, non-pharmacological strategies- Virtual Reality (VR) has gained popularity to improve overall the perioperative experience for patients.

Our overall aim was to develop and evaluate the use of a VR-based prototype to reduce pre-operative anxiety and post-operative acute pain intensity in our local patient population. Our primary objective was to develop a customized VR mindfulness application incorporating locally relevant scenarios and evaluate its feasibility, acceptability and preliminary associations with changes in perioperative anxiety and pain. Our secondary objectives included evaluating patient satisfaction and preferences for different VR modules.

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Key information

About this study

This will be a multi-center, prospective cohort study to be conducted in Changi General Hospital (CGH) and KKH, in collaboration with industry partner, Vue Networks. The patients will provide written informed consent for the study.

Phase 1: To facilitate the development of VR application that is suitable for perioperative care management, a survey will be conducted in 100 subjects (CGH: n=50; KKH: n=50) to gather patient preference and feedback with needs analysis.

The VR application development needs analysis would focus on:

i) instructional module on surgical journey; and ii) mindfulness module with inputs from perspectives of clinical health psychology iii) local relaxation scenarios (e.g. village, botanic gardens, Changi beach, Gardens by the bay); iv) feedback on hardware, i.e., VR headset usability.

Phase 2: The testing of the developed VR application will be performed in 60 subjects (CGH: n=30; KKH: n=30).

The study will utilize Head-Mounted Displays (HMD) such as the PicoG2 4K, the Oculus Go and/or Quest headsets. In immersive VR, high resolution 360-degree video and/or 3D computer graphics are paired with suitable ambience sounds and audio cues to fully immerse the user in the selected environment. The contents comprise a mixture of live-action and/or animation, as well as local settings. The domain components of the VR intervention include:

  • VR application for pre-operative anxiety and post-operative acute pain treatment with local context;
  • Patient feedback on local scenarios and content of VR and mindfulness;
  • Development of VR application: Vue Networks' platform with local and foreign context scenarios, passive and active scenario features, development of mindfulness application, language use for mindfulness application.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients aged 21 years old and above and undergoing scheduled surgery;
  • American Society of Anesthesiologist physical status I to III, with no visual or hearing impairment; and
  • Understands English or Chinese.

Exclusion criteria

  • Comorbidities affecting usage of virtual reality e.g., giddiness, motion sickness, claustrophobia, stroke, seizure, dementia, transmissible diseases, severe facial eczema; and
  • Unable to understand the administered questionnaires.

Treatment and study plan

Virtual reality

Device

Up to 25 minutes of virtual reality exposure in supine position

Primary outcomes

  1. Pre-operative anxiety

    Time frame: up to 1hour

    Anxiety score - VAS-A (0 to 10; 0-best outcome, 10-worst outcome)

Secondary outcomes

  1. Post-operative pain

    Time frame: up to 1hour

    Pain score - Numerical Rating Scale (0 to 10; 0-best outcome, 10-worst outcome)

  2. User satisfaction

    Time frame: up to 1hour

    Self-reported satisfaction score (0 to 10; 0-worst outcome, 10-best outcome)

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Collaborators

  • KK Women's and Children's Hospital

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2022
Registry last updated
Aug 14, 2026

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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