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

NCT ID: NCT07094451

Last Updated: 2025-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-02

Study Completion Date

2027-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Procedural Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Patients without Virtual Reality (VR)

Standard of care procedure without virtual reality.

Group Type ACTIVE_COMPARATOR

Ultrasound

Intervention Type PROCEDURE

Ultrasound-guided (US-Guided) procedure

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.

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type 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

Intervention Type PROCEDURE

Ultrasound-guided (US-Guided) procedure

Interventions

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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.

Intervention Type DEVICE

Ultrasound

Ultrasound-guided (US-Guided) procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* History of seizures
* Severe motion sickness
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Daniel Katz

Professor and Vice Chair of Education for the Department of Anesthesiology, Pain, & Perioperative Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Mount Sinai Obstetrics and Gynecology

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lucy Shang, BA

Role: CONTACT

212-241-7475

Facility Contacts

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Lauren Ferrera, MD

Role: primary

Other Identifiers

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STUDY-25-00020

Identifier Type: -

Identifier Source: org_study_id

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