Developing a Virtual Reality (VR)-Based Prototype for Perioperative Care - a Proof of Concept Study
Primary Purpose
Anxiety, Postoperative Pain, Pain, Acute
Status
Not yet recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring virtual reality, pain management, satisfaction experience
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.
Sites / Locations
- Changi General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Phase 1 - Patient feedback and needs analysis
Phase 2 - Evaluation of prototype efficacy
Arm Description
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.
Comparison of pre-operative anxiety and post-operative pain in 60 patients before and after intervention using the developed virtual reality application.
Outcomes
Primary Outcome Measures
Pre-operative anxiety
Anxiety score - VAS-A (0 to 10; 0-best outcome, 10-worst outcome)
Secondary Outcome Measures
Post-operative pain
Pain score - Numerical Rating Scale (0 to 10; 0-best outcome, 10-worst outcome)
User satisfaction
Self-reported satisfaction score (0 to 10; 0-worst outcome, 10-best outcome)
Full Information
NCT ID
NCT05564013
First Posted
September 29, 2022
Last Updated
September 30, 2022
Sponsor
Changi General Hospital
Collaborators
KK Women's and Children's Hospital (KKH)
1. Study Identification
Unique Protocol Identification Number
NCT05564013
Brief Title
Developing a Virtual Reality (VR)-Based Prototype for Perioperative Care - a Proof of Concept Study
Official Title
Developing a Virtual Reality (VR)-Based Prototype for Perioperative Care - a Proof of Concept Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changi General Hospital
Collaborators
KK Women's and Children's Hospital (KKH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Postoperative Pain, Pain, Acute
Keywords
virtual reality, pain management, satisfaction experience
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multi-center, prospective cohort study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phase 1 - Patient feedback and needs analysis
Arm Type
No Intervention
Arm Description
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.
Arm Title
Phase 2 - Evaluation of prototype efficacy
Arm Type
Experimental
Arm Description
Comparison of pre-operative anxiety and post-operative pain in 60 patients before and after intervention using the developed virtual reality application.
Intervention Type
Device
Intervention Name(s)
Virtual reality
Intervention Description
Up to 25 minutes of virtual reality exposure in supine position
Primary Outcome Measure Information:
Title
Pre-operative anxiety
Description
Anxiety score - VAS-A (0 to 10; 0-best outcome, 10-worst outcome)
Time Frame
up to 1hour
Secondary Outcome Measure Information:
Title
Post-operative pain
Description
Pain score - Numerical Rating Scale (0 to 10; 0-best outcome, 10-worst outcome)
Time Frame
up to 1hour
Title
User satisfaction
Description
Self-reported satisfaction score (0 to 10; 0-worst outcome, 10-best outcome)
Time Frame
up to 1hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seok Hwee S Koo
Phone
+6568504929
Email
seok_hwee_koo@cgh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lydia Weiling Li
Organizational Affiliation
Changi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siok Luan Ong
Phone
+65-64267280
Email
ong.siok.luan@singhealth.com.sg
First Name & Middle Initial & Last Name & Degree
Jason Ju In Chan
First Name & Middle Initial & Last Name & Degree
Chou Liang Mah
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33036555
Citation
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.
Results Reference
background
PubMed Identifier
32779029
Citation
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.
Results Reference
background
Learn more about this trial
Developing a Virtual Reality (VR)-Based Prototype for Perioperative Care - a Proof of Concept Study
We'll reach out to this number within 24 hrs