Virtual Reality + Olfactory Intervention for Postoperative Pain and Anxiety

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Massachusetts General Hospital

Disqualifiers: Cardiogenic shock, Hypertension, Heart disease, Renal insufficiency, Cirrhosis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if using virtual reality and pleasant smells can help reduce pain and anxiety in patients having heart or lung surgery. The treatment aims to offer a safer alternative to traditional medications like opioids. Patients will use VR headsets and scented necklaces to see if it helps them feel better. Virtual reality (VR) has been studied as an effective non-drug method for pain and anxiety management in various medical conditions and procedures.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It seems you may continue your usual medical care, but it's best to confirm with the trial coordinators.

What data supports the effectiveness of the treatment Virtual Reality and Olfactory Stimuli Therapy for postoperative pain and anxiety?

Research shows that virtual reality (VR) can help reduce pain and anxiety in patients undergoing surgery and those with burn injuries. Patients using VR for postsurgical pain management reported benefits without serious drawbacks, suggesting it can be a helpful non-drug option for recovery. ^{1 2 3 4 5}

Is the combination of virtual reality and olfactory stimuli safe for reducing pain and anxiety?

Research on virtual reality (VR) for reducing pain and anxiety shows it is generally safe, with no significant side effects reported. Studies have found VR helpful in reducing anxiety and pain during medical procedures, and it is considered a promising non-drug option for managing these symptoms. ^{1 2 6 7 8}

How is the VR/OS Multimodal Intervention treatment different from other treatments for postoperative pain and anxiety?

The VR/OS Multimodal Intervention is unique because it combines virtual reality (VR) with olfactory stimuli (smell-based therapy) to manage postoperative pain and anxiety, offering a non-drug approach that uses immersive experiences to distract and alter perception of pain. This treatment is novel as it leverages both visual and olfactory senses to enhance the therapeutic effect, potentially reducing the need for traditional pain medications like opioids. ^{1 7 9 10 11}

Research Team

Eligibility Criteria

Adults over 18 scheduled for certain cardiothoracic surgeries (like bypass grafting or lung resection) can join, except those with severe heart, kidney, liver issues, odor allergies, anosmia or cognitive/psychiatric conditions affecting consent.

Inclusion Criteria

I do not have any mental health conditions that prevent me from understanding or participating in the study.

I am scheduled for a major heart or chest surgery.

I am older than 18 years.

Exclusion Criteria

I showed signs of heart failure during surgery.

I have high blood pressure that cannot be controlled.

I have allergies to smells or I've lost my sense of smell.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Intervention

Participants receive the first virtual reality and olfactory stimuli therapy session approximately 2-4 weeks before surgery

2-4 weeks

1 visit (in-person)

Surgery and Immediate Pre-Surgery Intervention

Participants receive a virtual reality and olfactory stimuli session 90 minutes before surgery

1 day

1 visit (in-person)

Post-Surgery In-Hospital Recovery

Participants receive daily virtual reality and olfactory stimuli sessions in the afternoon and nighttime olfactory stimulation during in-hospital recovery

4 days

Daily sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Virtual Reality and Olfactory Stimuli Multimodal Intervention (Behavioural Intervention)

Trial Overview The study tests if a combo of virtual reality and scented devices can reduce pain and anxiety better than usual care in patients before and after cardiothoracic surgery. Participants are randomly chosen to receive either the VR/olfactory intervention or standard treatment.

Participant Groups

Group I: Virtual Reality and Olfactory Stimuli Arm Experimental Treatment 3 Interventions

Patients will undergo a virtual reality and olfactory stimuli therapy session at their appointment where they receive their pulmonary function test, 90 minutes before surgery, and each day they recover in the hospital. In addition, patients will receive nighttime olfactory stimulation using a bedside olfaction device.

Group II: Usual Care Arm Active Control 1 Intervention

No intervention will be given to patients in the usual care arm.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

Findings from Research

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]

Virtual Reality (VR) significantly reduces pain in burn injury patients during wound dressing changes and physiotherapy when used alongside pharmacologic analgesics, based on a systematic review of nine studies.

The evidence for VR's effectiveness in reducing anxiety during these procedures is less clear, indicating a need for further research to explore its potential benefits in managing anxiety for burn patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of virtual reality on reducing pain and anxiety in burn injury patients: a systematic review. Morris, LD., Louw, QA., Grimmer-Somers, K.[2022]

A systematic review of 11 randomized controlled trials involving 892 adult patients found that virtual reality (VR) interventions significantly reduce preoperative anxiety, with VR exposure being particularly effective.

In addition to lowering anxiety, VR interventions also effectively reduced heart rate and blood pressure compared to traditional methods, although they did not significantly impact respiration rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality in reducing preoperative anxiety in adults: A systematic review and meta-analysis. Gao, Y., Wang, N., Liu, N.[2023]

Self-administered Virtual Reality (VR) has been found to effectively aid in managing postsurgical pain, with patients reporting benefits and no serious drawbacks during its use.

Patients preferred intuitive, immersive 3D VR experiences and recommended using VR 2-3 times a day for 10-15 minutes, highlighting the importance of tailoring VR interventions to individual needs for optimal recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Administered Virtual Reality for Postsurgical Pain Management: A Qualitative Study of Hospital Patients' Reported Experiences. Lier, EJ., Smits, MLM., de Vries, M., et al.[2023]

Virtual reality (VR) interventions significantly reduce pain during burn wound care procedures compared to standard care, with a moderate effect size (SMD = -0.49) and even greater effectiveness when immersive VR is used (SMD = -0.71).

While VR shows promise in alleviating pain, it does not significantly improve range of motion outcomes, indicating that further research is needed to fully understand its benefits and to standardize its use in medical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality intervention as a support method during wound care and rehabilitation after burns: A systematic review and meta-analysis. Czech, O., Wrzeciono, A., Batalík, L., et al.[2022]

The use of interactive eye-tracked virtual reality (VR) significantly reduced presurgical anxiety by 67% in a case study of a 44-year-old female patient, demonstrating its potential as a nonpharmacologic anxiolytic.

The patient reported experiencing 'no fear' during VR compared to 'strong fear' without VR, indicating that VR can effectively distract and calm patients before surgery, suggesting a promising alternative to sedatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Immersive Virtual Reality Distraction to Reduce Fear and Anxiety before Surgery. Flores, A., Hoffman, HG., Navarro-Haro, MV., et al.[2023]

Virtual reality (VR) significantly reduces pain in pediatric patients undergoing needle-related procedures, with a meta-analysis of 3204 patients showing a mean difference of -2.85 on the Wong-Baker Faces Pain Rating Scale.

While VR was effective in decreasing pain, it did not show significant improvements in fear, anxiety, or satisfaction scores, indicating that more research is needed to fully understand its impact in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Interventions for Needle-Related Procedural Pain, Fear and Anxiety-A Systematic Review and Meta-Analysis. Czech, O., Wrzeciono, A., Rutkowska, A., et al.[2021]

Virtual reality (VR) is an effective non-drug method for pain management in hospitals, showing that higher levels of immersion, presence, and agency in VR experiences lead to greater pain relief across various medical conditions and procedures.

The use of VR not only helps reduce pain but may also alleviate anxiety, suggesting a shared biological mechanism between pain and anxiety that VR can target, making it a promising alternative to traditional analgesics amidst the opioid crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality as a Non-Pharmacological Adjunct to Reduce the Use of Analgesics in Hospitals. Theingi, S., Leopold, I., Ola, T., et al.[2022]

In a study of 106 adults recovering from hip arthroplasty, the use of virtual reality for relaxation and distraction did not significantly reduce postoperative pain or opioid consumption compared to a control group watching nature films.

The results showed no meaningful differences in pain scores or opioid requirements, indicating that the virtual reality program tested may not be an effective analgesic intervention in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Distraction for Reducing Acute Postoperative Pain After Hip Arthroplasty: A Randomized Trial. Araujo-Duran, J., Kopac, O., Montalvo Campana, M., et al.[2023]

References

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

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

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

The effectiveness of virtual reality on reducing pain and anxiety in burn injury patients: a systematic review. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality in reducing preoperative anxiety in adults: A systematic review and meta-analysis. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Self-Administered Virtual Reality for Postsurgical Pain Management: A Qualitative Study of Hospital Patients' Reported Experiences. [2023]

5. Scotland pubmed.ncbi.nlm.nih.gov

Virtual reality intervention as a support method during wound care and rehabilitation after burns: A systematic review and meta-analysis. [2022]

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

Using Immersive Virtual Reality Distraction to Reduce Fear and Anxiety before Surgery. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality Interventions for Needle-Related Procedural Pain, Fear and Anxiety-A Systematic Review and Meta-Analysis. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality as a Non-Pharmacological Adjunct to Reduce the Use of Analgesics in Hospitals. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Virtual reality and pain management: current trends and future directions. [2023]

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

Virtual Reality Distraction for Reducing Acute Postoperative Pain After Hip Arthroplasty: A Randomized Trial. [2023]