Virtual Reality for Pain Management During Anesthesia

Recruiting in Palo Alto (17 mi)

Overseen by Mary Vijjeswarapu, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Visual impairment, Epilepsy, Dementia, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests if using VR headsets showing calming scenes can help reduce pain and anxiety in patients aged 18-64 at Cedars-Sinai Medical Center during regional anesthesia. By distracting patients, VR may make them feel less pain and stress. Advancements in virtual reality (VR) technology have resulted in its expansion into health care.

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 data supports the effectiveness of the treatment Virtual Reality for pain management during anesthesia?

Research shows that virtual reality (VR) can help reduce pain and anxiety during medical procedures. For example, a case study found that using VR during an orthopedic procedure led to 43% less pain and anxiety compared to not using VR. This suggests VR could be a helpful tool for managing pain during anesthesia. ^{1 2 3 4 5}

Is virtual reality safe for use in pain management during anesthesia?

Research suggests that virtual reality (VR) is generally safe for use in medical settings, including during anesthesia, as it helps reduce anxiety and pain without the side effects associated with medications. VR has been used successfully in various procedures, such as dental work and orthopedic surgeries, with no significant safety concerns reported. ^{1 3 5 6 7}

How does virtual reality treatment for pain management during anesthesia differ from other treatments?

Virtual reality (VR) for pain management is unique because it offers a non-drug, immersive experience that distracts patients from pain by engaging them in a virtual environment. Unlike traditional pain medications, VR can reduce pain and anxiety without the side effects associated with drugs, and it can be used alongside other treatments to enhance pain relief. ^{1 8 9 10 11}

Research Team

Mary Vijjeswarapu, MD

Principal Investigator

CSMC Department of Anesthesiology

Eligibility Criteria

This trial is for elective pre-operative patients aged 18-64 at Cedars-Sinai Medical Center who are scheduled to receive regional anesthesia and can consent to participate. It excludes those with epilepsy, dementia, cognitive or visual impairments, pregnant women, and anyone outside the age range.

Inclusion Criteria

Patient must be able to provide informed consent

I am scheduled for surgery at Cedars-Sinai and will receive regional anesthesia.

I am between 18 and 64 years old.

Exclusion Criteria

I have been diagnosed with epilepsy, dementia, or cognitive issues.

I have trouble seeing.

I am younger than 18 or older than 64.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-operative Assessment

Participants complete a questionnaire to assess anxiety and pain levels prior to regional anesthesia

1 hour

1 visit (in-person)

Regional Anesthesia Procedure

Participants undergo regional anesthesia with or without VR, and complete a questionnaire to assess anxiety and pain levels during the procedure

1 hour

1 visit (in-person)

Post-procedure Assessment

Participants complete a questionnaire to assess anxiety and pain levels after the regional anesthesia procedure

1 hour

1 visit (in-person)

Treatment Details

Interventions

• Virtual Reality with Oculus Go headset (Behavioural Intervention)

Trial Overview The study investigates how using Virtual Reality (VR) via an Oculus Go headset affects pain and anxiety management in patients undergoing regional anesthesia before surgery.

Participant Groups

Group I: Experimental Group (VR) Experimental Treatment 1 Intervention

Patients will be randomly allocated to the the experimental group, which receives VR during the regional anesthesia procedure.

Group II: Control Group (no VR) Active Control 1 Intervention

Patients will be randomly allocated to the control group, which receives no Virtual Reality (VR) during the regional anesthesia procedure.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

David E. Cohen

Cedars-Sinai Medical Center

Chief Medical Officer

MD and PhD in Physiology and Biophysics from Harvard University

Peter L. Slavin

Cedars-Sinai Medical Center

Chief Executive Officer

MD from Harvard Medical School, MBA from Harvard Business School

Findings from Research

A study involving 42 laboring women found that immersive virtual reality (VR) significantly increased patient satisfaction during labor, with a high mean satisfaction score of 87.7 out of 100, and 95% of participants expressing a desire to use VR in future labors.

The use of VR also led to a notable reduction in pain scores during early labor, decreasing from a mean of 2.6 to 2.0 on a visual pain rating scale, indicating its potential as an effective pain relief tool in labor settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive virtual reality on childbirth experience for women: a randomized controlled trial. Carus, EG., Albayrak, N., Bildirici, HM., et al.[2022]

Virtual reality (VR) therapies have shown promise in effectively distracting patients from both acute and chronic pain, suggesting a new approach to pain management beyond traditional methods like opioids and physical therapy.

Clinical studies indicate that VR can be beneficial for various pain conditions, including fibromyalgia and phantom limb pain, by immersing patients in interactive environments that reduce their perception of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality as a Clinical Tool for Pain Management. Pourmand, A., Davis, S., Marchak, A., et al.[2018]

A study involving 32 patients undergoing head and neck surgery found that different virtual reality (VR) experiences did not significantly differ in their effectiveness for reducing perioperative anxiety and pain, suggesting that both preoperative gaming and postoperative mindfulness VR can be equally beneficial.

Patients reported high satisfaction with both VR interventions, and there were no adverse events, indicating that VR is a safe and effective tool for managing anxiety and pain in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Perioperative Virtual Reality Experiences on Anxiety and Pain: A Randomized Comparative Trial. Pandrangi, VC., Low, G., Slijepcevic, A., et al.[2023]

Over the past 20 years, there has been a notable decrease in adverse events related to sedation outside of operating rooms, highlighting improvements in patient safety during procedures.

Immersive virtual reality (VR) is emerging as an effective non-pharmacologic technique to distract patients from anxiety and pain during various medical procedures, with its application expected to grow as technology advances and costs decrease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role of Virtual Reality as an Adjunct to Procedural Sedation and Anesthesia: A Narrative Review. Hitching, R., Hoffman, HG., Garcia-Palacios, A., et al.[2023]

A study involving 100 hospitalized patients showed that a one-time 3D virtual reality (VR) intervention significantly reduced pain more than a 2D distraction video, with an average pain reduction of -1.3 points compared to -0.6 points for the control group.

The VR intervention was not only effective, with 65% of patients experiencing a meaningful pain response, but it was also safe, as no adverse events were reported during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. Tashjian, VC., Mosadeghi, S., Howard, AR., et al.[2020]

This umbrella review analyzed 21 systematic reviews and meta-analyses involving 17,680 patients, confirming that virtual reality is effective in managing various pain conditions, including chronic pain and pain related to medical procedures.

Virtual reality is a promising alternative therapy for pain management in both children and adults, showing benefits across multiple pain settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality for pain management: an umbrella review. Viderman, D., Tapinova, K., Dossov, M., et al.[2023]

A study involving 77 healthy volunteers demonstrated that a High-Tech VR helmet significantly reduced procedural pain more effectively than a Low-Tech VR helmet, with participants reporting up to 34% less worst pain and 46% less pain unpleasantness.

The High-Tech VR helmet also led to a higher percentage of participants experiencing clinically significant pain reduction (65% vs. 29% in the Low-Tech group), emphasizing the importance of VR technology quality in pain management during medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality helmet display quality influences the magnitude of virtual reality analgesia. Hoffman, HG., Seibel, EJ., Richards, TL., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Case Report: Virtual Reality Analgesia in an Opioid Sparing Orthopedic Outpatient Clinic Setting: A Case Study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Immersive virtual reality on childbirth experience for women: a randomized controlled trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Virtual Reality as a Clinical Tool for Pain Management. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Use of Perioperative Virtual Reality Experiences on Anxiety and Pain: A Randomized Comparative Trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Use of Virtual Reality as a Surrogate for Parental Presence During Anesthetic Induction: A Case Report. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Emerging Role of Virtual Reality as an Adjunct to Procedural Sedation and Anesthesia: A Narrative Review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Guided relaxation-based virtual reality versus distraction-based virtual reality or passive control for postoperative pain management in children and adolescents undergoing Nuss repair of pectus excavatum: protocol for a prospective, randomised, controlled trial (FOREVR Peds trial). [2021]

8. Canada pubmed.ncbi.nlm.nih.gov

Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

[Use of Virtual Reality as a Component of Acute and Chronic Pain Treatment]. [2020]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual reality for pain management: an umbrella review. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Virtual reality helmet display quality influences the magnitude of virtual reality analgesia. [2022]