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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgery, Cardiac

Intervention / Treatment
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* Device: Virtual Reality
* Drug: Kalinox


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR<br>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<br>* Deepsen offers a VR platform that provides patients with immersive contents aimed to distract, inform, soften and improve the healthcare experience<br>|
| Active Comparator: Kalinox®<br>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<br>* Gas mixture composed of 50% Nitrous Oxide and 50% Oxygen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of patient comfort | Variation of the Analgesia / Nociception Index (ANI) | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of pain during drain removal | Pain numerical rating scale (NRS) ranging from 0 to 10 (0=no pain, 10=worst possible pain) | 30 minutes | 
| Level of anxiety during drain removal | Anxiety NRS ranging from 0 to 10 (0=no stress, 10=worst possible stress) | 30 minutes | 
| Morphine consumption | Cumulated dose of oxynorm (mg) | 1 hour | 
| Side effects due to Virtual Reality | Onset of vertigo, nausea or vomiting | 2 hours | 
| Patient satisfaction | Satisfaction verbal rating scale (VRS) ranging from 0 to 4 (0=unsatisfied, 4=very satisfied) | 2 hours | 
| Health staff satisfaction | Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied) | 30 minutes | 
| Side effects due to Kalinox | Onset of delirium, euphoria or headache | 2 hours | 
| Correlation between ANI and Pain NRS |  | 30 minutes | 
| Correlation between ANI and Anxiety NRS |  | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Anxiety, Mediastinal drain removal