NCT04912531 Virtual Reality and Olfactory Stimuli Multimodal Intervention to Reduce Post-Operative Pain and Anxiety in Patients Undergoing Cardiothoracic Surgery

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 80 participants in total. It began in 2022-10-01 with a primary completion date of 2028-05-31.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Be scheduled to undergo any one of the 5 major types of cardiothoracic surgical operations: coronary artery bypass grafting, aortic valve replacement, aortic valve repair, lung resection, and esophagectomy * Age \> 18 * No cognitive or psychiatric conditions prohibiting study consent or participation. 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)

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