ARVACC: Interest of Virtual Reality in the Management of Anxiety and Pain Related to Post-cardiac Surgery Care
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: VR VR Installation 5 min before the drain removal and stop 10 min after the procedure. If Pain assessed by numerical rating scale (NRS) > 4, administration of morphine. |
Device: Virtual Reality
Deepsen offers a VR platform that provides patients with immersive contents aimed to distract, inform, soften and improve the healthcare experience
|
| Active Comparator: Kalinox® Start of Kalinox® administration by inhalation with a facial mask 1 min before the drain removal and stop after the procedure according to the usual procedure of the service. If Pain NRS > 4, administration of morphine. |
Drug: Kalinox
Gas mixture composed of 50% Nitrous Oxide and 50% Oxygen
|
Outcome Measures
Primary Outcome Measures
- Assessment of patient comfort [30 minutes]
Variation of the Analgesia / Nociception Index (ANI)
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Extubated after cardiac surgery
-
Sinus rhythm
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Consent for participation
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Affiliation to the social security system
Exclusion Criteria:
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Pacemaker
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Visual acuity making impossible the use of virtual reality
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Intolerance to morphine
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Contraindication to Kalinox®
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Pregnant or breastfeeding women
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Patients under protection of the adults (guardianship, curators or safeguard of justice)
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Communication difficulties or neuropsychiatric disorder
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CMC Ambroise Paré | Neuilly-sur-Seine | Ile-de-France | France | 92200 |
Sponsors and Collaborators
- CMC Ambroise Paré
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019/01