Virtual Reality and Olfactory Stimuli Multimodal Intervention to Reduce Post-Operative Pain and Anxiety in Patients Undergoing Cardiothoracic Surgery (NCT04912531)
Using a Virtual Reality and Olfactory Stimuli Multimodal Intervention to Reduce Post-Operative Pain and Anxiety in Patients Undergoing Cardiothoracic Surgery
🩺 Plain-English Summary (8th-Grade Level)
Patients who undergo cardiothoracic surgery often experience pain and anxiety around the time of surgery. Currently, treatments for pain and anxiety around the time of surgery include opioids and benzodiazepines, which can have severe side effects and can be ineffective. Interventions combining virtual reality with olfactory stimuli are a promising alternative to opioids and benzodiazepines in the treatment of pain and anxiety around the time of surgery. The aim of this study is to evaluate the feasibility of a virtual reality and olfactory stimuli multimodal intervention in patients undergoing cardiothoracic surgery. In addition, the investigators will evaluate the preliminary effects of the VR/OS intervention on patient pain and anxiety before and after cardiothoracic surgery. Patients who meet study inclusion criteria and are undergoing cardiothoracic surgery may participate in this study. Patients have an equal being assigned to undergo the virtual reality and olfactory stimuli intervention or continue getting usual medical care with their doctor. If the patient is assigned to receive the virtual reality and olfactory stimuli intervention, the first therapy session will take place approximately two to four weeks before surgery. This will involve wearing a virtual reality headset and scented necklace for approximately 10 minutes. The second session will occur 90 minutes before the surgery. Additionally, for each day the patient recovers in the hospital after surgery, the patient will receive one session in the afternoon. During the patient's in-hospital recovery at night, they will receive lavender scented therapy.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (7 items).
Location: Massachusetts General Hospital — Boston, Massachusetts
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Clinical signs of cardiogenic shock at time of surgery
- Severe irreversible hypertension
- Congenital heart disease
- Chronic renal insufficiency defined by Cr ≥ 2.5 or chronic renal replacement therapy
- Evidence of cirrhosis or hepatic synthetic failure
- Patients with odor allergies or anosmia (lost their sense of smell)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Massachusetts General Hospital — Boston, Massachusetts
📞 Contact the Study Coordinator
Phone: (814) 574-8695
Email: cjyang@mgh.harvard.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: Additionally, for each day the patient recovers in the hospital after surgery, the patient will receive one session in the afternoon.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.