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

ConditionProcedural Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18

English-speaking

Undergoing ultrasound-guided needle procedure at Mount Sinai

Disqualifiers

History of seizures

Severe motion sickness

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Ultrasound

    Procedure/Surgery

    Ultrasound-guided (US-Guided) procedure

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Patients without Virtual Reality (VR)Active comparator 1 intervention
Group B: Patients with Virtual RealityExperimental treatment 2 interventions

Trial outcomes

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).

Time frame
Immediately post-procedure

Secondary outcomes

1

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.

Time frame
Immediately post-procedure (procedure lasts approximately 20 minutes)
2

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.

Time frame
Immediately Pre-procedure and immediately post-procedure (procedure lasts approximately 20 minutes)
3

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.

Time frame
Immediately post-procedure (procedure lasts approximately 20 minutes)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

Source ClinicalTrials.gov
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