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NCT Number: NCT07094451

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

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.

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Key information

Conditions

Procedural Pain Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Obstetrics and Gynecology

New York, 10029, United States

Location status: Recruiting

Location contact

Daniel Katz, MD

PRINCIPAL_INVESTIGATOR

Lauren Ferrera, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • History of seizures
  • Severe motion sickness

Treatment and study plan

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

Primary outcomes

  1. Short-form McGill Pain Questionnaire

    Time frame: Immediately post-procedure

    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).

Secondary outcomes

  1. Acceptability of Intervention Measure (AIM)

    Time frame: Immediately post-procedure (procedure lasts approximately 20 minutes)

    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.

  2. State-Trait Anxiety Inventory (STAI)

    Time frame: Immediately Pre-procedure and immediately post-procedure (procedure lasts approximately 20 minutes)

    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.

  3. Visual Analog Scale for Satisfaction

    Time frame: Immediately post-procedure (procedure lasts approximately 20 minutes)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lucy Shang, BA

CONTACT

[email protected]

212-241-7475

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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