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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Anxiety; Pain, Acute
• Intervention / Treatment: Device: Virtual reality

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seok Hwee S Koo; Phone Number: +6568504929; Email: seok_hwee_koo@cgh.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 529889
    • Changi General Hospital
    • Principal Investigator: Jason Ju In Chan
    • Sub-Investigator: Chou Liang Mah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Phase 1 - Patient feedback and needs analysis; 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.
EXPERIMENTAL: Phase 2 - Evaluation of prototype efficacy; Comparison of pre-operative anxiety and post-operative pain in 60 patients before and after intervention using the developed virtual reality application.	Device: Virtual reality; Up to 25 minutes of virtual reality exposure in supine position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-operative anxiety	Anxiety score - VAS-A (0 to 10; 0-best outcome, 10-worst outcome)	up to 1hour

Secondary Outcome Measures

Outcome Measure	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)	up to 1hour

Collaborators and Investigators

• Sponsor: Changi General Hospital
• Collaborators: KK Women's and Children's Hospital (KKH)
• Investigators: Principal Investigator: Lydia Weiling Li, Changi General Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2022
• Primary Completion (ANTICIPATED): September 1, 2023
• Study Completion (ANTICIPATED): September 1, 2023

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (ACTUAL): October 3, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: virtual reality; pain management; satisfaction experience
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: VIRTUAL02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No