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Recruiting NCT07094451

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

No phase Interventional Procedural Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality, Ultrasound.
Who it may be relevant to
Registry conditions: Procedural Pain. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Virtual Reality for Pain Control During US-guided Needle Procedures in Obstetric Patients: A Prospective Pilot Study

Overview

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.

Interventions

  • Device 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.
  • Procedure Ultrasound
    Ultrasound-guided (US-Guided) procedure

Primary outcome measures

  • Short-form McGill Pain Questionnaire [Time frame: Immediately post-procedure]
Secondary outcome measures (3)
  • Acceptability of Intervention Measure (AIM) [Time frame: Immediately post-procedure (procedure lasts approximately 20 minutes)]
  • State-Trait Anxiety Inventory (STAI) [Time frame: Immediately Pre-procedure and immediately post-procedure (procedure lasts approximately 20 minutes)]
  • Visual Analog Scale for Satisfaction [Time frame: Immediately post-procedure (procedure lasts approximately 20 minutes)]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • History of seizures
  • Severe motion sickness

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Mount Sinai Obstetrics and Gynecology — New York

Identifiers

NCT: NCT07094451 · STUDY-25-00020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗