Status:

RECRUITING

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

Lead Sponsor:

Massachusetts General Hospital

Conditions:

Postoperative Pain

Anxiety Postoperative

Eligibility:

All Genders

18+ years

Phase:

NA

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 benz...

Detailed Description

Every year, over 500,000 individuals in the United States undergo cardiothoracic surgery for heart and lung disease. Cardiothoracic surgery can be an extremely traumatic experience for the patient. Th...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

October 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2025

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT04912531

Start Date

October 1 2022

End Date

June 30 2025

Last Update

November 19 2024

Active Locations (1)

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1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114