80 Participants Needed

Virtual Reality + Olfactory Intervention for Postoperative Pain and Anxiety

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.23456

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.
See 3 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual Reality and Olfactory Stimuli ArmExperimental Treatment3 Interventions
Group II: Usual Care ArmActive Control1 Intervention

Find a Clinic Near You

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

Citations

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 ...
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 ...
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.
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 ...
(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
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 ...
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