NCT07094451

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Jul 2025Mar 2027

Study Start

First participant enrolled

July 2, 2025

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2027

Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

1.7 years

First QC Date

July 23, 2025

Last Update Submit

July 23, 2025

Conditions

Procedural Pain

Keywords

Virtual realityProcedural anxietyUltrasound-guidedObstetric patientsNon-pharmacologic pain controlImmersive distraction

Outcome Measures

Primary Outcomes (1)

  • Short-form McGill Pain Questionnaire

    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).

    Immediately post-procedure

Secondary Outcomes (3)

  • Acceptability of Intervention Measure (AIM)

    Immediately post-procedure (procedure lasts approximately 20 minutes)

  • State-Trait Anxiety Inventory (STAI)

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

  • Visual Analog Scale for Satisfaction

    Immediately post-procedure (procedure lasts approximately 20 minutes)

Study Arms (2)

Patients without Virtual Reality (VR)

ACTIVE COMPARATOR

Standard of care procedure without virtual reality.

Procedure: Ultrasound

Patients with Virtual Reality

EXPERIMENTAL

Ultrasound-guided (US-Guided) procedure with virtual reality. Participants will wear a Meta Quest 2 virtual reality headset during their ultrasound-guided needle procedure.

Device: Virtual RealityProcedure: Ultrasound

Interventions

Virtual RealityDEVICE

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.

Patients with Virtual Reality
UltrasoundPROCEDURE

Ultrasound-guided (US-Guided) procedure

Patients with Virtual RealityPatients without Virtual Reality (VR)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • History of seizures
  • Severe motion sickness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Obstetrics and Gynecology

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Pain, Procedural

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Daniel Katz, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucy Shang, BA

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Vice Chair of Education for the Department of Anesthesiology, Pain, & Perioperative Medicine

Study Record Dates

First Submitted

July 23, 2025

First Posted

July 30, 2025

Study Start

July 2, 2025

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2027

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

This is a single-site, small-scale pilot study that does not include the collection of biospecimens or long-term follow-up data. The data collected are limited to de-identified questionnaire responses.

Locations

US(1)