Use of Virtual Reality in Pain Management in Hospitalized Patients
Primary Purpose
Pain, Acute, Pain, Chronic
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Acute focused on measuring virtual reality, pain management, inpatients
Eligibility Criteria
Inclusion Criteria:
Hospitalised patients with complain of pain issues (at least one of the following),
- Acute pain
- Acute exacerbations of chronic pain
- Chronic non-cancer pain
- Post-procedural pain (limited to those who undergo procedures with < 2 hours in duration)
- Age equal or more than ≥ 21 years,
- No visual or hearing impairment,
- English literacy.
Exclusion Criteria:
- Cancer-related pain,
- Comorbidities affecting usage of VR e.g. motion sickness, stroke, seizure, dementia, transmissible diseases, severe facial eczema,
- Undergoing litigation.
Sites / Locations
- Changi General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtual reality intervention
Arm Description
Comparison of pain and anxiety levels before and after VR intervention within the same patient.
Outcomes
Primary Outcome Measures
Patient acceptability and tolerability
Validated questionnaires - patient experience satisfaction (0 to 10; 0-worst outcome, 10-best outcome), System Usability Scale (<50-not acceptable, 50-70-marginal, >70-acceptable)
Secondary Outcome Measures
Clinical efficacy of virtual reality
Pain and anxiety scores (0 to 10; 0-best outcome, 10-worst outcome)
Full Information
NCT ID
NCT05545033
First Posted
September 11, 2022
Last Updated
September 14, 2022
Sponsor
Changi General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05545033
Brief Title
Use of Virtual Reality in Pain Management in Hospitalized Patients
Official Title
Evaluating the Feasibility and Acceptability of the Use of Virtual Reality in Pain Management in Hospitalized Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
March 16, 2022 (Actual)
Study Completion Date
March 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changi General Hospital
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
Acute and chronic non-cancer pain is a common healthcare problem locally and globally, leading to many inpatient admissions for poorly controlled pain. The World Health Organisation has declared that access to adequate pain control is a fundamental human right. Yet in our current practice, both acute and chronic non-cancer pain remain poorly controlled.
There is passive over-reliance on pharmacological agents and interventional procedures in the management of pain. The opioid epidemic with issues of dependence, misuse, and overdose is especially concerning. Therefore, there is a pertinent clinical need to find sustainable non-pharmacological adjuncts in the complex management of pain.
Virtual reality (VR) involves the use of technology to create a three-dimensional multisensory artificial environment replacing real-world sensory inputs. Initially created solely for entertainment purposes, VR applications have since expanded and made its way into healthcare. In Pain Medicine, the application of VR has been promising. There is currently no VR study done in our local population who suffer from pain issues. In our study, we aim to test the feasibility of applying the use of VR in patients admitted inpatient due to pain issues. We believe that VR can be used as an adjunctive tool improve pain management and patient satisfaction.
Detailed Description
Patients who agree to participate in the study will undergo the following procedures:
Provide written informed consent,
Provide baseline demographic information,
Provide baseline pain and anxiety ratings,
Undergo 5 to 15 minutes VR exposure,
Take 3 to 5 minutes break,
Undergo 5 to 15 minutes VR exposure,
Provide post-intervention pain and anxiety ratings,
Complete validated questionnaires.
The Oculus Go Head-Mounted Devices (HMD) will be put in place on the patients as follows:
Patient places sanitary hairnet on head,
Patient places disposable face liners secured by rubber bands over their ears,
Study coordinator places pre-sanitized Oculus Go HMD over patient's disposable face mask and adjusts straps for comfort.
Trial Product:
This study will be using immersive VR technology for intervention and management of acute and chronic pain. It will deploy the latest commercially available all-in-one HMDs as an adjunct to pain management in an inpatient hospital setting.
The VR hardware configuration and all content is currently being developed by technology partner Vue Networks, a leader in the development of VR content for implementation in education and training for the Social Sciences sector and in health and mental wellness for community and institutional usage, such as for the elderly and demented in hospitals and in nursing homes. Content experts consulted include certified MBCT practitioners as well as VR content researchers in Singapore and Germany.
VR Hardware: This study will utilize the Oculus Go all-in-one HMD set designed by Facebook Reality Labs. This is the first wireless HMD created that is able to display 4K images in a 3-degrees of Freedom environment.
VR Software: In immersive VR, high resolution (minimum 4K) 360-degree video and 3D computer graphics and paired with suitable ambience sounds and audio cues to fully immerse the user in the selected environment.
The proposed VR experiences include the following:
Gardens by the Bay - Limit-Oriented Therapy (Cognitive Restructuring)
Animated Nature Environment - Enhance-Oriented Therapy (Mindfulness Meditation)
Animated Beach Environment - Active-Oriented Therapy (Behavioural Activation)
Underwater Fish & Mammals - Integrated Treatment (Multimodal Treatment)
Content will be a mixture of life-action and animation, as well as foreign and local
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Pain, Chronic
Keywords
virtual reality, pain management, inpatients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open-label, single centre, single-arm pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality intervention
Arm Type
Experimental
Arm Description
Comparison of pain and anxiety levels before and after VR intervention within the same patient.
Intervention Type
Device
Intervention Name(s)
Virtual reality
Intervention Description
5 to 15 minutes of virtual reality exposure
Primary Outcome Measure Information:
Title
Patient acceptability and tolerability
Description
Validated questionnaires - patient experience satisfaction (0 to 10; 0-worst outcome, 10-best outcome), System Usability Scale (<50-not acceptable, 50-70-marginal, >70-acceptable)
Time Frame
post-intervention (up to 1 hr)
Secondary Outcome Measure Information:
Title
Clinical efficacy of virtual reality
Description
Pain and anxiety scores (0 to 10; 0-best outcome, 10-worst outcome)
Time Frame
pre- and post-intervention (up to 1hr)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hospitalised patients with complain of pain issues (at least one of the following),
Acute pain
Acute exacerbations of chronic pain
Chronic non-cancer pain
Post-procedural pain (limited to those who undergo procedures with < 2 hours in duration)
Age equal or more than ≥ 21 years,
No visual or hearing impairment,
English literacy.
Exclusion Criteria:
Cancer-related pain,
Comorbidities affecting usage of VR e.g. motion sickness, stroke, seizure, dementia, transmissible diseases, severe facial eczema,
Undergoing litigation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lydia 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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27349654
Citation
Mosadeghi S, Reid MW, Martinez B, Rosen BT, Spiegel BM. Feasibility of an Immersive Virtual Reality Intervention for Hospitalized Patients: An Observational Cohort Study. JMIR Ment Health. 2016 Jun 27;3(2):e28. doi: 10.2196/mental.5801.
Results Reference
background
PubMed Identifier
27997539
Citation
Jones T, Moore T, Choo J. The Impact of Virtual Reality on Chronic Pain. PLoS One. 2016 Dec 20;11(12):e0167523. doi: 10.1371/journal.pone.0167523. eCollection 2016.
Results Reference
background
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Use of Virtual Reality in Pain Management in Hospitalized Patients
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