Virtual Reality for Pain Control in US-Guided Obstetric Needle Procedures

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07094451
Status
Recruiting
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Conditions

  • Procedural Pain

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Virtual Reality — DEVICE
    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 — PROCEDURE
    Ultrasound-guided (US-Guided) procedure

Study Details

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.

Key Dates

Start date
Jul 2, 2025
Status verified
Jul 2025
Primary completion
Mar 30, 2027
Completion
Mar 30, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Patients without Virtual Reality (VR)
    Standard of care procedure without virtual reality.
  • Experimental: Patients with Virtual Reality
    Ultrasound-guided (US-Guided) procedure with virtual reality. Participants will wear a Meta Quest 2 virtual reality headset during their ultrasound-guided needle procedure.

Primary Outcome Measure

Short-form McGill Pain Questionnaire [ Time Frame: Immediately post-procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai Obstetrics and GynecologyNew YorkNew York10029
Lauren Ferrera, MD
[email protected]
Daniel Katz, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Mount Sinai Obstetrics and Gynecology· New York, NY

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