CMC Ambroise Paré
Neuilly-sur-Seine, Île-de-France Region, 92200, France
NCT Number: NCT03956264
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Neuilly-sur-Seine, Île-de-France Region, 92200, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 30 minutes
Variation of the Analgesia / Nociception Index (ANI)
Time frame: 30 minutes
Pain numerical rating scale (NRS) ranging from 0 to 10 (0=no pain, 10=worst possible pain)
Time frame: 30 minutes
Anxiety NRS ranging from 0 to 10 (0=no stress, 10=worst possible stress)
Time frame: 1 hour
Cumulated dose of oxynorm (mg)
Time frame: 2 hours
Onset of vertigo, nausea or vomiting
Time frame: 2 hours
Satisfaction verbal rating scale (VRS) ranging from 0 to 4 (0=unsatisfied, 4=very satisfied)
Time frame: 30 minutes
Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied)
Time frame: 2 hours
Onset of delirium, euphoria or headache
Time frame: 30 minutes
Time frame: 30 minutes
CMC Ambroise Paré
Other
Acronym: ARVACC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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