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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients without Virtual Reality (VR) | Active Comparator | Standard of care procedure without virtual reality. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Intervention Measure (AIM) | 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucy Shang, BA | Contact | 212-241-7475 | lucy.shang@icahn.mssm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Katz, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Obstetrics and Gynecology | Recruiting | New York | New York | 10029 | United States |
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.
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| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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|
| Ultrasound | Procedure | Ultrasound-guided (US-Guided) procedure |
|
| Immediately post-procedure (procedure lasts approximately 20 minutes) |
| State-Trait Anxiety Inventory (STAI) | 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. | Immediately Pre-procedure and immediately post-procedure (procedure lasts approximately 20 minutes) |
| Visual Analog Scale for Satisfaction | 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. | Immediately post-procedure (procedure lasts approximately 20 minutes) |
| D055585 |
| Physical Phenomena |