Recruiting

VR

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07094451

Conditions

Procedural Pain

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Virtual Reality

Ultrasound

Study Details

Brief summary:

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.

Conditions

Procedural Pain

Study ID

NCT07094451

Start date

Jul 2, 2025

Status verified date

Aug, 2026

Completion date

Apr 6, 2027

Anticipated

Primary completion date

Apr 6, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Age ≥18
  • English-speaking
  • Undergoing ultrasound-guided needle procedure at Mount Sinai

Exclusion criteria:

  • History of seizures
  • Severe motion sickness

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Virtual Reality

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

Ultrasound-guided (US-Guided) procedure

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Lucy Shang, BA

212-241-7475lucy.shang@icahn.mssm.edu

Locations

Mount Sinai Obstetrics and Gynecology

Recruiting

New York, New York, United States, 10029

Contacts

Lauren Ferrera, MD

lauren.ferrara@mssm.edu

Principal Investigator:

Daniel Katz, MD

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Virtual reality
  • Procedural anxiety
  • Ultrasound-guided
  • Obstetric patients
  • Non-pharmacologic pain control
  • Immersive distraction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-08-27.