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

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 30 days later Sep 30, 2027 → Oct 30, 2027
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Record History

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  1. Minor Primary completion pushed from Sep 30, 2027 to Oct 30, 2027
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 1 of 3 entries
  2. Notable Primary completion date: Sep 30, 2026 to Sep 30, 2027
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  4. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06685107
Lead Sponsor Antonios Likourezos
Conditions
(from sponsor)
Acute Musculoskeletal Pain
Related terms Acute Pain
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov