Clinical trial NCT06685107: Virtual Reality and Standard Care vs. Standard Care Alone for Acute MSK Pain in Geriatric ED Patients
Official title: Combination of Virtual Reality and Standard of Care Versus Standard of Care Alone for Acute Musculoskeletal Pain Management in Geriatric Emergency Department Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Musculoskeletal Pain
Keywords: Geriatric
Emergency Medicine
Virtual Reality
Acute Pain
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 180
Sex: ALL
Minimum age (years): 65
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain Reduction
timeFrame: 60 minutes
Secondary outcomes:
measure: Anxiety
timeFrame: 60 minutes
measure: Acute Stress
timeFrame: 60 minutes
measure: Adverse Effects
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
affiliation: Maimonides Medical Center
name: Sergey Motov, MD
role: PRINCIPAL_INVESTIGATOR
References: