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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
200
Deepsen offers a VR platform that provides patients with immersive contents aimed to distract, inform, soften and improve the healthcare experience
Gas mixture composed of 50% Nitrous Oxide and 50% Oxygen
CMC Ambroise Paré
Neuilly-sur-Seine, Île-de-France Region, France
Assessment of patient comfort
Variation of the Analgesia / Nociception Index (ANI)
Time frame: 30 minutes
Level of pain during drain removal
Pain numerical rating scale (NRS) ranging from 0 to 10 (0=no pain, 10=worst possible pain)
Time frame: 30 minutes
Level of anxiety during drain removal
Anxiety NRS ranging from 0 to 10 (0=no stress, 10=worst possible stress)
Time frame: 30 minutes
Morphine consumption
Cumulated dose of oxynorm (mg)
Time frame: 1 hour
Side effects due to Virtual Reality
Onset of vertigo, nausea or vomiting
Time frame: 2 hours
Patient satisfaction
Satisfaction verbal rating scale (VRS) ranging from 0 to 4 (0=unsatisfied, 4=very satisfied)
Time frame: 2 hours
Health staff satisfaction
Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied)
Time frame: 30 minutes
Side effects due to Kalinox
Onset of delirium, euphoria or headache
Time frame: 2 hours
Correlation between ANI and Pain NRS
Time frame: 30 minutes
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Correlation between ANI and Anxiety NRS
Time frame: 30 minutes