Virtual Reality for Procedural Pain

Overseen By Lucy Shang, BA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Seizures, Severe motion sickness

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality (VR) can reduce pain and anxiety during certain needle procedures for pregnant patients. Participants will either use VR or receive standard care to determine which option improves the experience. The trial seeks English-speaking adults undergoing ultrasound-guided needle procedures at Mount Sinai Hospital who have no history of seizures or severe motion sickness. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance patient comfort during medical procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that virtual reality is safe for reducing procedural pain and anxiety in obstetric patients?

Research has shown that using virtual reality (VR) in medical settings is generally safe. Studies have found that VR can reduce anxiety and pain during medical procedures without causing major side effects. For example, a review of several studies found that VR safely lowers anxiety in hospital patients. Another study showed it successfully reduced pain and anxiety in children undergoing surgery. These findings suggest that VR is well-tolerated and does not cause serious problems. While results can vary, the overall evidence indicates that VR is a safe option for managing pain and anxiety during medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) for procedural pain because it offers a novel way to distract patients during medical procedures. Unlike traditional pain management options like local anesthesia or sedatives, VR immerses patients in a virtual environment, potentially reducing anxiety and discomfort without additional medication. This method could lead to fewer side effects and a more engaging experience for patients undergoing procedures like ultrasound-guided needle insertions. By leveraging technology like the Meta Quest 2 VR headset, this approach aims to make medical procedures less daunting and improve patient comfort.

What evidence suggests that virtual reality is effective for reducing procedural pain and anxiety?

Research shows that virtual reality (VR) can help reduce pain and anxiety during medical procedures. In this trial, some participants will undergo ultrasound-guided procedures using VR, wearing a Meta Quest 2 virtual reality headset. Studies have found that patients using VR report feeling less pain immediately after their procedures. VR distracts patients, allowing them to focus on the virtual world instead of the pain. This approach works well for both adults and children in various situations. Early evidence also suggests that VR can reduce anxiety about upcoming medical procedures. Overall, VR appears to be a promising tool for managing pain and anxiety during medical treatments. ^{2 6 7 8 9}

Who Is on the Research Team?

Daniel Katz, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for obstetric patients at Mount Sinai Hospital who are experiencing procedural pain and will undergo ultrasound-guided needle procedures. Participants should be willing to use VR or receive standard care and complete questionnaires about their pain, anxiety, and satisfaction with the intervention.

Inclusion Criteria

English-speaking

Undergoing ultrasound-guided needle procedure at Mount Sinai

I am 18 years old or older.

Exclusion Criteria

Severe motion sickness

I have a history of seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Participants undergo ultrasound-guided needle procedures with or without virtual reality

20 minutes

1 visit (in-person)

Follow-up

Participants complete questionnaires assessing pain, anxiety, intervention acceptability, and satisfaction immediately after the procedure

Immediately post-procedure

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality

Trial Overview The study is testing whether virtual reality can help control pain and reduce anxiety during ultrasound-guided obstetric needle procedures compared to standard care. It's a pilot study where patients are randomly chosen to get either VR or the usual treatment while being monitored.

How Is the Trial Designed?

Group I: Patients with Virtual Reality Experimental Treatment 2 Interventions

Ultrasound-guided (US-Guided) procedure with virtual reality. Participants will wear a Meta Quest 2 virtual reality headset during their ultrasound-guided needle procedure.

Group II: Patients without Virtual Reality (VR) Active Control 1 Intervention

Standard of care procedure without virtual reality.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10865524/

Efficacy of virtual reality for pain relief in medical procedures Our primary outcome was pain scores measured immediately after or within an hour of the procedure. We also collected data on anxiety scores ...

2. researchprotocols.org researchprotocols.org/2024/1/e52649

Effectiveness of Virtual Reality in Reducing Perceived Pain ... The purpose of this pilot project is to assess the efficacy of using VR as a distraction-based intervention for anxiety or pain management.

3. bmcemergmed.biomedcentral.com bmcemergmed.biomedcentral.com/articles/10.1186/s12873-025-01285-x

The impact of virtual reality (VR) on pain management in the ... Overall, VR offers effective pain management in adults and pediatric patients with non-procedural acute pain and those undergoing painful ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02794103

Virtual Reality Distraction for Procedural Pain Management ... The aim of this study is to assess the feasibility and preliminary efficacy of a virtual reality prototype developed specifically for the hydrotherapy room of ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1524904224001000

Effects of Virtual Reality on Analgesia in Wound Care and ... The results of this meta-analysis indicate that VR can effectively reduce worst pain intensity, pain unpleasantness intensity, and time spent thinking about ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12589719/

Virtual Reality Is Safe and Can Reduce In‐Hospital Anxiety ... The extent to which VR is evident in improving patient outcomes is unknown. This systematic review assesses the impact of VR on adult patients ...

7. frontiersin.org frontiersin.org/journals/virtual-reality/articles/10.3389/frvir.2021.699383/full

The Effects of Virtual Reality on Procedural Pain and ... The present study is a systematic review and meta-analysis of studies that have used VR to reduce procedural pain and anxiety in children.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0882596325000697

Virtual reality for distraction during painful procedures in ... The study shows how VR affects the pain and anxiety of pediatric surgery patients. Children in the experimental group reported less pain and anxiety.

9. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-024-03266-6

Efficacy of virtual reality for pain relief in medical procedures Immersive VR technology offers effective pain control across various medical procedures, albeit statistical heterogeneity.