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

Not Applicable

Recruiting

• Conditions: Procedural Pain

• Registration Number: NCT07094451
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-02
• Study First Submitted: 2025-07-23
• Study First Submitted QC: 2025-07-23
• Last Update Submitted: 2025-07-23
• Study First Posted: 2025-07-30
• Last Update Posted: 2025-07-30
• Primary Completion: 2027-03-30
• Study Completion: 2027-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Short-form McGill Pain Questionnaire	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 Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory (STAI)	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.
Acceptability of Intervention Measure (AIM)	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.
Visual Analog Scale for Satisfaction	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.

Trial Locations

Locations (1)

Mount Sinai Obstetrics and Gynecology; 🇺🇸 New York, New York, United States