Surgery, Cardiac
Conditions
Keywords
Pain, Anxiety, Mediastinal drain removal
Brief 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.
Interventions
DEVICEVirtual Reality
Deepsen offers a VR platform that provides patients with immersive contents aimed to distract, inform, soften and improve the healthcare experience
DRUGKalinox
Gas mixture composed of 50% Nitrous Oxide and 50% Oxygen
Sponsors
CMC Ambroise Paré
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Extubated after cardiac surgery * Sinus rhythm * Consent for participation * Affiliation to the social security system
Exclusion criteria
* Pacemaker * Visual acuity making impossible the use of virtual reality * Intolerance to morphine * Contraindication to Kalinox® * Pregnant or breastfeeding women * Patients under protection of the adults (guardianship, curators or safeguard of justice) * Communication difficulties or neuropsychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of patient comfort | 30 minutes | Variation of the Analgesia / Nociception Index (ANI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of pain during drain removal | 30 minutes | Pain numerical rating scale (NRS) ranging from 0 to 10 (0=no pain, 10=worst possible pain) |
| Level of anxiety during drain removal | 30 minutes | Anxiety NRS ranging from 0 to 10 (0=no stress, 10=worst possible stress) |
| Morphine consumption | 1 hour | Cumulated dose of oxynorm (mg) |
| Side effects due to Virtual Reality | 2 hours | Onset of vertigo, nausea or vomiting |
| Patient satisfaction | 2 hours | Satisfaction verbal rating scale (VRS) ranging from 0 to 4 (0=unsatisfied, 4=very satisfied) |
| Health staff satisfaction | 30 minutes | Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied) |
| Side effects due to Kalinox | 2 hours | Onset of delirium, euphoria or headache |
| Correlation between ANI and Pain NRS | 30 minutes | — |
| Correlation between ANI and Anxiety NRS | 30 minutes | — |
Countries
France
Outcome results
None listed