Virtual Reality + Olfactory Intervention for Postoperative Pain and Anxiety

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

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

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

Compensation: Varies

Number of Visits: 2

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage pain and anxiety for individuals undergoing heart or lung surgery. Instead of relying on drugs like opioids, which can cause serious side effects, the study tests a combination of virtual reality and pleasant scents (Virtual Reality and Olfactory Stimuli Multimodal Intervention) to determine if they improve patient well-being before and after surgery. Participants will either receive this new therapy or continue with their usual care. This trial suits those scheduled for specific heart or lung surgeries, provided they do not have extreme blood pressure issues or allergies to scents. As an unphased trial, it offers patients the opportunity to explore innovative therapies that could enhance their surgical experience.

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 prior data suggests that this virtual reality and olfactory intervention is safe for postoperative pain and anxiety management?

Research shows that using virtual reality (VR) with pleasant smells can help reduce pain and anxiety. Although this method is new, early studies suggest it is safe for people. VR is often used for anxiety without serious issues. Pleasant smells are generally well-tolerated as well. Overall, reports of significant negative effects from combining VR and scents are lacking. This approach offers a promising option for managing pain and anxiety without the side effects of traditional medications like opioids and benzodiazepines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Reality and Olfactory Stimuli treatment because it combines immersive technology with scent therapy to tackle postoperative pain and anxiety in a new way. Unlike traditional pain management options, which often rely on medication, this approach uses virtual reality to distract and engage the mind, while olfactory stimuli can have a calming effect, potentially enhancing overall patient comfort. This multimodal intervention is non-invasive and could provide a complementary or alternative option to pharmaceuticals, offering a holistic way to manage recovery.

What evidence suggests that the Virtual Reality and Olfactory Stimuli Multimodal Intervention is effective for postoperative pain and anxiety?

Research has shown that virtual reality (VR) can lower pain levels and increase pain tolerance in people with chronic pain. Studies suggest that combining VR with pleasant smells might reduce pain and anxiety more effectively than some medications, such as opioids and benzodiazepines, which can cause side effects. A review of several studies found that VR slightly reduced anxiety before surgery. Another study indicated that olfactory virtual reality (a combination of VR and scents) improved well-being and reduced stress, anxiety, and pain for hospital patients. In this trial, participants in the Virtual Reality and Olfactory Stimuli Arm will experience this combined approach, which could be a promising way to manage pain and anxiety around surgeries. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality and Olfactory Stimuli Multimodal 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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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) 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 case study demonstrated that immersive virtual reality (VR) significantly reduced pain intensity by 43% and anxiety by 43% during the removal of external fixator pins in a conscious patient, compared to standard care without VR.

Using VR as a non-pharmacologic analgesic not only improved patient satisfaction with pain management but also has the potential to lower opioid use and associated risks during outpatient orthopedic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: Virtual Reality Analgesia in an Opioid Sparing Orthopedic Outpatient Clinic Setting: A Case Study. Firoozabadi, R., Elhaddad, M., Drever, S., et al.[2021]

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]

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]

Virtual reality (VR) has been shown to effectively reduce pain and distress during various medical procedures, with participants expressing a desire to use VR again for similar experiences.

The exact neurobiological mechanisms of how VR provides pain relief are still being studied, but it is believed to work through emotional and cognitive processes that influence the body's pain modulation system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality and pain management: current trends and future directions. Li, A., Montaño, Z., Chen, VJ., et al.[2023]

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/19799?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Virtual Reality and Olfactory Stimuli Multimodal Interven... Encouragingly, studies have demonstrated the ability of VR to decrease pain intensity and increase pain tolerance in patients suffering from chronic pain. In ...

2. ctv.veeva.com ctv.veeva.com/study/virtual-reality-and-olfactory-stimuli-multimodal-intervention-to-reduce-post-operative-pain-and-anxi

Virtual Reality and Olfactory Stimuli Multimodal Intervention to ... Interventions combining virtual reality with olfactory stimuli are a promising alternative to opioids and benzodiazepines in the treatment of ...

3. withpower.com withpower.com/trial/phase-pain-postoperative-9-2021-75cbe

Virtual Reality + Olfactory Intervention for Postoperative Pain and ... This trial tests if using virtual reality and pleasant smells can help reduce pain and anxiety in patients having heart or lung surgery.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12340745/

Effectiveness of Virtual Reality Interventions for Perioperative ... The meta‐analysis revealed a small, non‐significant reduction in preoperative anxiety, favouring VR (Standardised Mean Difference − 0.29, 95% Confidence ...

5. researchgate.net researchgate.net/publication/350157692_Olfactory_Virtual_Reality_OVR_for_Wellbeing_and_Reduction_of_Stress_Anxiety_and_Pain

(PDF) Olfactory Virtual Reality (OVR) for Wellbeing and ... This study investigates the utilization of Olfactory Virtual Reality (OVR) in an inpatient psychiatry unit, more specifically in the Shepardson 3

6. clinicaltrial.be clinicaltrial.be/en/details/19799?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Virtual Reality and Olfactory Stimuli Multimodal Interven... There is potential for an intervention combining VR and OS to lead to a greater reduction in pain and anxiety. Pain and anxiety are ...