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

NCT05564013 | Completed

• 1 other identifier: VIRTUAL02
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Anxiety; Postoperative Pain; Pain, Acute

Keywords

virtual reality; pain management; satisfaction experience

Outcome Measures

Primary Outcomes (1)

• Pre-operative anxiety

  Anxiety score - VAS-A (0 to 10; 0-best outcome, 10-worst outcome)

  up to 1hour

Secondary Outcomes (2)

• Post-operative pain

  up to 1hour

• User satisfaction

  up to 1hour

Study Arms (2)

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.

Device: Virtual reality

Interventions

Virtual reality DEVICE

Up to 25 minutes of virtual reality exposure in supine position

Phase 2 - Evaluation of prototype efficacy

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KK Women's and Children's Hospital: collaborator
• Changi General Hospital: lead

Study Sites (2)

Changi General Hospital

Singapore, Singapore, 529889, Singapore

Location

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Related Publications (2)

• 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.

  PMID: 33036555 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.

  PMID: 32779029 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain, Postoperative; Acute Pain; Agnosia

Condition Hierarchy (Ancestors)

Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Lydia Weiling Li

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Department of Anaesthesia and Surgical Intensive Care

Model Details: Multi-center, prospective cohort study

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 3, 2022
• Study Start: April 20, 2023
• Primary Completion: March 19, 2024
• Study Completion: March 19, 2024
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)