Virtual Reality and Standard Care vs. Standard Care Alone for Acute MSK Pain in Geriatric ED Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-120
SponsorAntonios Likourezos

About this trial

The proposed Virtual Reality as an Adjunct to Pain Management for Geriatric Patients in the ED (VRAP-ED) project will take place in the Emergency Medicine Department at Maimonides Medical Center. It seeks to enhance the analgesic practices for geriatric patients with acute painful conditions in the emergency setting. Although virtual reality (VR) has demonstrated effectiveness in reducing pain and anxiety in various clinical settings for juveniles and adults, the analgesic efficacy of VR for geriatric ED patients lacks established data. The project will use a geriatric-focused VR platform.

The project intends to improve pain management for almost 200 geriatric patients by evaluating the effectiveness of virtual reality (VR) in reducing pain and its impact on anxiety \& stress reduction. The research project will conduct a randomized clinical trial to investigate the analgesic efficacy and impact on anxiety \& stress by using VR as an adjunct to the standard of care (SOC) for pain management in elderly patients presenting to the ED with acute musculoskeletal pain. This will be investigated through a prospective, randomized, non-blinded clinical trial conducted over two years. Eligible patients will be randomly assigned to either the control (SOC) or intervention (SOC+VR) groups. The expected outcomes of this research study will provide insight into the feasibility of using VR in a busy emergency setting for one of the most commonly encountered painful syndromes and to assess the analgesic efficacy as well as the satisfaction of VR application by both patients and ED clinicians.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age of 65+

Emergency Medicine patients

non traumatic musculoskeletal painful condition

pain score of 4+ on the numeric rating scale

Disqualifiers

painful syndrome requiring emergent and/or urgent pain control

altered mental status

unstable vital signs

history of recent epilepsy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard of Care Analgesia

    Other intervention

    Analgesia as determined by the treating physician

  • Standard of Care Analgesia + Virtual Reality

    Other intervention

    Analgesia as determined by the treating physician and Virtual Reality experience that will use a geriatric-focused VR platform that has age appropriate VR content and will run for approximately 5-10 minutes

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Standard of Care (SOC)Active comparator 1 intervention
Group B: Virtual Reality (VR) + Standard of Care (SOC)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain Reduction

A reduction of pain scores on the Numeric Rating Scale (0: no pain; 5 moderate pain; 10 extreme pain)

Time frame
60 minutes

Secondary outcomes

1

Anxiety

Anxiety will be measured by the Spielberger State-Trait Anxiety Inventory (STAI-S) scale which range is between 20 and 80, with scores \>40 indicative of appreciable anxiety.

Time frame
60 minutes
2

Acute Stress

Acute Stress will be measured by 11-point stress Numerical Rating Scale (SNRS-11) (0 no stress; 5 moderate stress, 10: extreme stress) and at a self-reported nominal level

Time frame
60 minutes
3

Adverse Effects

Adverse Effects occurring such as headache, dizziness, nausea, motion sickness

Time frame
60 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Antonios Likourezos

Lead sponsor

Maimonides Medical Center

Sponsor institution