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

NCT ID: NCT05564013

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2023-09-30

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.

Conditions

Anxiety; Postoperative Pain; Pain, Acute

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: DEVICE

Up to 25 minutes of virtual reality exposure in supine position

Interventions

Virtual reality

Up to 25 minutes of virtual reality exposure in supine position

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KK Women's and Children's Hospital (KKH)

UNKNOWN

Sponsor Role: collaborator

Changi General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lydia Li Weiling

Consultant, Department of Anaesthesia and Surgical Intensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lydia Weiling Li

Role: PRINCIPAL_INVESTIGATOR

Changi General Hospital

Locations

Changi General Hospital

Singapore, , Singapore

Countries

Singapore

Central Contacts

Seok Hwee S Koo

Role: CONTACT

seok_hwee_koo@cgh.com.sg

+6568504929

Facility Contacts

Siok Luan Ong

Role: primary

ong.siok.luan@singhealth.com.sg

+65-64267280

References

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.

Reference Type: BACKGROUND

PMID: 33036555 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32779029 (View on PubMed)

Other Identifiers

VIRTUAL02

Identifier Type: -

Identifier Source: org_study_id