An interventional study of Standard of Care Analgesia and Standard of Care Analgesia + Virtual Reality in Acute Musculoskeletal Pain, sponsored by Antonios Likourezos. Recruiting at 1 site in United States. Open to participants aged 65 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Antonios Likourezos · Not applicable, Interventional, and Treatment
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.
The investigators will conduct a prospective, randomized, non-blinded clinical trial, over a 2-year period, to investigate the efficacy of virtual reality (VR) on pain reduction as a primary outcome (quantitative outcome) and its effect on anxiety and stress (qualitative outcomes) as secondary outcomes in geriatric patients presenting to the ED of Maimonides Medical Center. This clinical trial will focus on patients with complaints of acute traumatic and non-traumatic musculoskeletal pain. These patients will be screened for eligibility and approached by study investigators. Upon meeting the eligibility criteria and completing an informed consent form, patients will be randomized into one of two study groups: 1) Standard of Care or 2) Standard of Care (SOC) plus Virtual Reality. Subjects will include geriatric patients, ages 65 and older, presenting to the ED with acute traumatic and non-traumatic musculoskeletal (MSK) painful syndromes with an initial numeric pain score of 4 and above on a standard 11 point (0 to 10) numeric rating scale (NRS) and requiring analgesia as determined by the treating ED physician. The total sample size for this trial will be 180 subjects (90 per group).
Eligible subjects in the trial will be randomized to either the control group or the intervention group. The control group will receive the standard of care (SOC) analgesia as determined by their treating physician and departmental guidelines. The intervention group will receive VR therapy via a headset as an adjunct to the SOC therapies prescribed. Study investigators will record pain scores, vital signs, and adverse effects at 0, 15, 30, 60, 90, and 120 minutes. In addition, anxiety and stress will be assessed before and after utilization of VR in the intervention group at 0, 30, 60 and 120 minutes. Subjects enrolled in the control group will have an evaluation of anxiety and stress recorded at 0, 30, 60, and 120 minutes as a part of secondary outcome measures as well.
Exclusion Criteria:
Analgesia as determined by the treating physician
Other: Standard of Care Analgesia
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
Other: Standard of Care Analgesia + Virtual Reality
Analgesia as determined by the treating physician
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
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
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
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
Adverse Effects
Adverse Effects occurring such as headache, dizziness, nausea, motion sickness
Time frame: 60 minutes
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Antonios Likourezos