Changi General Hospital
Singapore, 529889
NCT Number: NCT05564013
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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Notify Me21 year–70 year
All sexes
Interventional
Not applicable
Singapore, 529889
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Up to 25 minutes of virtual reality exposure in supine position
Time frame: up to 1hour
Anxiety score - VAS-A (0 to 10; 0-best outcome, 10-worst outcome)
Time frame: up to 1hour
Pain score - Numerical Rating Scale (0 to 10; 0-best outcome, 10-worst outcome)
Time frame: up to 1hour
Self-reported satisfaction score (0 to 10; 0-worst outcome, 10-best outcome)
Changi General Hospital
Other
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