NCT05545033

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

1.2 years

First QC Date

September 11, 2022

Last Update Submit

September 14, 2022

Conditions

Keywords

virtual realitypain managementinpatients

Outcome Measures

Primary Outcomes (1)

  • 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)

    post-intervention (up to 1 hr)

Secondary Outcomes (1)

  • Clinical efficacy of virtual reality

    pre- and post-intervention (up to 1hr)

Study Arms (1)

Virtual reality intervention

EXPERIMENTAL

Comparison of pain and anxiety levels before and after VR intervention within the same patient.

Device: Virtual reality

Interventions

5 to 15 minutes of virtual reality exposure

Virtual reality intervention

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Cancer-related pain,
  • Comorbidities affecting usage of VR e.g. motion sickness, stroke, seizure, dementia, transmissible diseases, severe facial eczema,
  • Undergoing litigation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (2)

  • 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.

    PMID: 27349654BACKGROUND
  • 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.

    PMID: 27997539BACKGROUND

MeSH Terms

Conditions

Acute PainChronic PainAgnosia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Lydia Li

    Changi General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open-label, single centre, single-arm pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Department of Anaesthesia and Surgical Intensive Care

Study Record Dates

First Submitted

September 11, 2022

First Posted

September 19, 2022

Study Start

January 20, 2021

Primary Completion

March 16, 2022

Study Completion

March 16, 2022

Last Updated

September 19, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations