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

NCT06685107 | Recruiting

• 1 other identifier: 2023-09-05
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Musculoskeletal Pain

Keywords

Geriatric; Emergency Medicine; Virtual Reality; Acute Pain

Outcome Measures

Primary Outcomes (1)

• Pain Reduction

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

  60 minutes

Secondary Outcomes (3)

• Anxiety

  60 minutes

• Acute Stress

  60 minutes

• Adverse Effects

  60 minutes

Study Arms (2)

Standard of Care (SOC)

ACTIVE COMPARATOR

Analgesia as determined by the treating physician

Other: Standard of Care Analgesia

Virtual Reality (VR) + Standard of Care (SOC)

ACTIVE COMPARATOR

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

Interventions

Standard of Care Analgesia OTHER

Analgesia as determined by the treating physician

Standard of Care (SOC)

Standard of Care Analgesia + Virtual Reality OTHER

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

Virtual Reality (VR) + Standard of Care (SOC)

Eligibility Criteria

• Age: 65 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age of 65+
• Emergency Medicine patients
• non traumatic musculoskeletal painful condition
• pain score of 4+ on the numeric rating scale
• patient will warrant parenteral analgesia per treating physician
• patient will have to be awake, alert, and oriented to person, place, and time.
• comprehension of informed consent process and study related content
• ability to complete assessments

You may not qualify if:

• painful syndrome requiring emergent and/or urgent pain control
• altered mental status
• unstable vital signs
• history of recent epilepsy
• seizure disorder
• vertigo
• active headache
• nausea
• motion sickness
• dizziness

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

RECRUITING

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sergey Motov, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergey Motov, MD

CONTACT

718-283-6000; smotov@maimo.org

Antonios Likourezos, MA, MPH

CONTACT

alikourezos@maimo.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Administration Director

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 12, 2024
• Study Start: November 18, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (1)