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

Not Applicable

Not yet recruiting

• Conditions: Postoperative Pain; Pain, Acute; Anxiety
• Interventions: Device: Virtual reality

• Registration Number: NCT05564013
• Lead Sponsor: Changi General Hospital

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 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.

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.

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-29
• Study First Submitted QC: 2022-09-30
• Last Update Submitted: 2022-09-30
• Study Start: 2022-10
• Study First Posted: 2022-10-03
• Last Update Posted: 2022-10-03
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase 2 - Evaluation of prototype efficacy	Virtual reality	Comparison of pre-operative anxiety and post-operative pain in 60 patients before and after intervention using the developed virtual reality application.

Primary Outcome Measures

Name	Time	Method
Pre-operative anxiety	up to 1hour	Anxiety score - VAS-A (0 to 10; 0-best outcome, 10-worst outcome)

Secondary Outcome Measures

Name	Time	Method
Post-operative pain	up to 1hour	Pain score - Numerical Rating Scale (0 to 10; 0-best outcome, 10-worst outcome)
User satisfaction	up to 1hour	Self-reported satisfaction score (0 to 10; 0-worst outcome, 10-best outcome)

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore