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| Name | Class |
|---|---|
| KK Women's and Children's Hospital | OTHER_GOV |
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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 is 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 aim is to reduce preoperative anxiety as measured by a reduction in Visual Analogue Score-Anxiety (VAS-A) by a mean of 2.5 points pre-post VR intervention. Our secondary aims are to reduce post-operative acute pain and to achieve more than 50% good to excellent self-reported satisfaction on our VR prototype.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 - Patient feedback and needs analysis | No Intervention | To facilitate the development of virtual reality application that is suitable for perioperative care management, a survey will be conducted in 100 subjects to gather patient preference and feedback with needs analysis. | |
| Phase 2 - Evaluation of prototype efficacy | Experimental | Comparison of pre-operative anxiety and post-operative pain in 60 patients before and after intervention using the developed virtual reality application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality | Device | Up to 25 minutes of virtual reality exposure in supine position |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pre-operative anxiety | Anxiety score - VAS-A (0 to 10; 0-best outcome, 10-worst outcome) | up to 1hour |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain | Pain score - Numerical Rating Scale (0 to 10; 0-best outcome, 10-worst outcome) | up to 1hour |
| User satisfaction | Self-reported satisfaction score (0 to 10; 0-worst outcome, 10-best outcome) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seok Hwee S Koo | Contact | +6568504929 | seok_hwee_koo@cgh.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Lydia Weiling Li | Changi General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changi General Hospital | Singapore | 529889 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33036555 | Background | Chan JJI, Yeam CT, Kee HM, Tan CW, Sultana R, Sia ATH, Sng BL. The use of pre-operative virtual reality to reduce anxiety in women undergoing gynecological surgeries: a prospective cohort study. BMC Anesthesiol. 2020 Oct 9;20(1):261. doi: 10.1186/s12871-020-01177-6. | |
| 32779029 | Background | Goldman RD, Behboudi A. Virtual reality for intravenous placement in the emergency department-a randomized controlled trial. Eur J Pediatr. 2021 Mar;180(3):725-731. doi: 10.1007/s00431-020-03771-9. Epub 2020 Aug 10. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Multi-center, prospective cohort study
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| up to 1hour |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |