An interventional study of Virtual Reality and Ultrasound in Procedural Pain, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Supportive care
This is a single-site randomized controlled pilot study at Mount Sinai Hospital evaluating the effect of virtual reality on procedural pain and anxiety in obstetric patients undergoing ultrasound-guided needle procedures. Patients will be randomized to receive either VR or standard care during the procedure and complete validated questionnaires assessing pain, anxiety, intervention acceptability, and satisfaction.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's planned enrollment of 50 is below the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion criteria:
Standard of care procedure without virtual reality.
Procedure: Ultrasound
Ultrasound-guided (US-Guided) procedure with virtual reality. Participants will wear a Meta Quest 2 virtual reality headset during their ultrasound-guided needle procedure.
Device: Virtual Reality · Procedure: Ultrasound
Meta Quest 2 virtual reality headset. The VR experience includes an interactive, immersive environment with classical music and wrist-controlled movement to match floating visual cues to a beat. The experience is designed to be soothing and require minimal movement.
Ultrasound-guided (US-Guided) procedure
Short-form McGill Pain Questionnaire
The Short-form McGill Pain Questionnaire (SF-MPQ) is used to assess procedural pain and its qualities, such as 'sharpness.' The total score ranges from 0 to 45, with higher scores indicating more pain. It includes subscales for Sensory (0-33), Affective (0-12), a Visual Analogue Scale (0-10), and Present Pain Intensity (0-5).
Time frame: Immediately post-procedure
Acceptability of Intervention Measure (AIM)
This is a short, 4-question survey that helps the research team understand how acceptable participants found the use of virtual reality (VR) during their procedure. Participants rate each statement (ex: "The VR intervention meets my approval") on a scale from 1 (completely disagree) to 5 (completely agree). The total score ranges from 4 to 20, with higher scores indicating greater acceptability of the VR experience.
Time frame: Immediately post-procedure (procedure lasts approximately 20 minutes)
State-Trait Anxiety Inventory (STAI)
The STAI is a 20-item instrument assessing anxiety before and after procedure. Each item is rated on a 4-point scale from 1-4. Total scale range from 20 to 80, with higher scores indicating higher state anxiety.
Time frame: Immediately Pre-procedure and immediately post-procedure (procedure lasts approximately 20 minutes)
Visual Analog Scale for Satisfaction
This is a simple one-question survey where participants rate how satisfied they were with their overall procedure experience. They will mark their satisfaction on a scale from 1 to 10, where 1 means "not satisfied at all" and 10 means "completely satisfied." The total score ranges from 1 to 10, with higher scores indicating greater satisfaction.
Time frame: Immediately post-procedure (procedure lasts approximately 20 minutes)
Plan to share: No — This is a single-site, small-scale pilot study that does not include the collection of biospecimens or long-term follow-up data. The data collected are limited to de-identified questionnaire responses.
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Apr 2027, 21 months after the start.
Of 141 non-industry interventional studies with no phase under Pain, Procedural, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 21 months is above that.
Counting every sponsor, half of 141 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
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