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

NCT05564013 | Unknown

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

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.

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

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

Study Sites (1)

Changi General Hospital

Singapore, 529889, 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

Central Study Contacts

Seok Hwee S Koo

CONTACT

+6568504929; seok_hwee_koo@cgh.com.sg

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: October 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)