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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05564013
Enrollment
160
Registered
2022-10-03
Start date
2023-04-20
Completion date
2024-03-19
Last updated
2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Pain, Acute, Postoperative Pain

Keywords

virtual reality, pain management, satisfaction experience

Brief summary

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.

Detailed description

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.

Interventions

DEVICEVirtual reality

Up to 25 minutes of virtual reality exposure in supine position

Sponsors

Changi General Hospital
Lead SponsorOTHER
KK Women's and Children's Hospital
CollaboratorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Multi-center, prospective cohort study

Eligibility

Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pre-operative anxietyup to 1hourAnxiety score - VAS-A (0 to 10; 0-best outcome, 10-worst outcome)

Secondary

MeasureTime frameDescription
Post-operative painup to 1hourPain score - Numerical Rating Scale (0 to 10; 0-best outcome, 10-worst outcome)
User satisfactionup to 1hourSelf-reported satisfaction score (0 to 10; 0-worst outcome, 10-best outcome)

Countries

Singapore

Contacts

PRINCIPAL_INVESTIGATORLydia Weiling Li

Changi General Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026