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

CMC Ambroise Paré

Status: Completed

Conditions: Surgery, Cardiac

Treatments: Drug: Kalinox; Device: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT03956264

2019/01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

VR

Experimental group

Description:

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.

Treatment:

Device: Virtual Reality

Kalinox®

Active Comparator group

Description:

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.

Treatment:

Drug: Kalinox