Procedural Pain
Conditions
Keywords
Virtual reality, Procedural anxiety, Ultrasound-guided, Obstetric patients, Non-pharmacologic pain control, Immersive distraction
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.
Interventions
DEVICEVirtual 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.
PROCEDUREUltrasound
Ultrasound-guided (US-Guided) procedure
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 * English-speaking * Undergoing ultrasound-guided needle procedure at Mount Sinai
Exclusion criteria
* History of seizures * Severe motion sickness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Contacts
CONTACTLucy Shang, BA
PRINCIPAL_INVESTIGATORDaniel Katz, MD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed