NCT03956264

Interest of Virtual Reality in the Management of Anxiety and Pain Related to Post-cardiac Surgery Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: CMC Ambroise Paré · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study compares Virtual Reality versus Nitrous oxide administration for the management of anxiety and pain related to post-cardiac surgery care, especially during removal of mediastinal drainage.

Detailed description

After cardiac surgery, the mediastinal and pleural drains are usually removed the second postoperative day, in the absence of complications. This procedure, realized by nurses, is a source of anxiety and pain for patients. Nitrous oxide (Kalinox®) is commonly used to manage many situations of anxiety, including the removal of mediastinal and/or pleural drains, and has shown a greater effect than placebo in this indication. Virtual Reality (VR) is a recent technology that allows the representation of a pleasant environment in three dimensions with a complete immersion by a helmet. By distracting patients, this technology can reduce anxiety, discomfort and ultimately pain associated with care. This randomized monocentric trial compares VR versus Kalinox® administration for the management of anxiety and pain related to post-cardiac surgery care, especially mediastinal and/or pleural drain removal.

Conditions

• Surgery, Cardiac

Interventions

Type	Name	Description
DEVICE	Virtual Reality	Deepsen offers a VR platform that provides patients with immersive contents aimed to distract, inform, soften and improve the healthcare experience
DRUG	Kalinox	Gas mixture composed of 50% Nitrous Oxide and 50% Oxygen

Timeline

• Start date: 2019-09-26
• Primary completion: 2020-07-24
• Completion: 2020-07-24
• First posted: 2019-05-20
• Last updated: 2026-04-08

Locations

1 site across 1 country: France