Procedural PainNCT07094451
Virtual Reality for Pain Control in US-Guided Obstetric Needle Procedures
A study testing Virtual Reality and Ultrasound in people with Procedural Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Procedural Pain
- What is being tested?
- Virtual Reality and Ultrasound
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2025to 6 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18
- English-speaking
- Undergoing ultrasound-guided needle procedure at Mount Sinai
Who cannot join
- History of seizures
- Severe motion sickness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai Obstetrics and Gynecology
New York, New York, 10029
Lauren Ferrera, MD, lauren.ferrara@mssm.edu
Daniel Katz, MD
About this study
Official title: Virtual Reality for Pain Control During US-guided Needle Procedures in Obstetric Patients: A Prospective Pilot Study
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.
- Conditions
- Procedural Pain
- Being tested
- Virtual Reality, Ultrasound
- Keywords
- Virtual reality, Procedural anxiety, Ultrasound-guided, Obstetric patients, Non-pharmacologic pain control, Immersive distraction
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
UltrasoundProcedure or surgery
Ultrasound-guided (US-Guided) procedure
| Study group | Role | What they receive |
|---|---|---|
| Patients without Virtual Reality (VR) | Active comparator | Standard of care procedure without virtual reality. Receives: 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. Receives: Device: Virtual Reality; Procedure: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Immediately post-procedure
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Immediately post-procedure (procedure lasts approximately 20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start2 Jul 2025
- Primary completion6 Apr 2027 (estimated)
- Study completion6 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Katz, Icahn School of Medicine at Mount Sinai
- Investigators
- Daniel Katz, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094451
- Sponsor's protocol ID
- STUDY-25-00020
- Status last verified
- Aug 2026
- First submitted
- 23 Jul 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for Pain Control During US-guided Needle Procedures in Obstetric Patients: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT07094451
- Acronym / sponsor ID
- STUDY-25-00020
- Conditions
- Procedural Pain
- Keywords
- Virtual reality, Procedural anxiety, Ultrasound-guided, Obstetric patients, Non-pharmacologic pain control, Immersive distraction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 6 Apr 2027 (estimated)
- Study completion
- 6 Apr 2027 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without Virtual Reality (VR) | Active comparator | Procedure: UltrasoundStandard of care procedure without virtual reality. |
| Patients with Virtual Reality | Experimental | Device: Virtual Reality, Procedure: UltrasoundUltrasound-guided (US-Guided) procedure with virtual reality. Participants will wear a Meta Quest 2 virtual reality headset during their ultrasound-guided needle procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18
- English-speaking
- Undergoing ultrasound-guided needle procedure at Mount Sinai
Key exclusion criteria (2 listed)
- History of seizures
- Severe motion sickness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityMeta 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. | Device | Patients with Virtual Reality |
| UltrasoundUltrasound-guided (US-Guided) procedure | Procedure or surgery | Patients with Virtual Reality, Patients without Virtual Reality (VR) |
Primary outcome
Short-form McGill Pain Questionnaire
Time frame: 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).
3 secondary outcomes
Acceptability of Intervention Measure (AIM)
Time frame: Immediately post-procedure (procedure lasts approximately 20 minutes)
State-Trait Anxiety Inventory (STAI)
Time frame: Immediately Pre-procedure and immediately post-procedure (procedure lasts approximately 20 minutes)
Visual Analog Scale for Satisfaction
Time frame: Immediately post-procedure (procedure lasts approximately 20 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Katz, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Ultrasound in people with Procedural Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucy Shang, BA (212-241-7475, lucy.shang@icahn.mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-form McGill Pain Questionnaire (time frame: Immediately post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.